- 2026.03.19
Active ingredients Message type Date of last report Type of reason AM designation Salbutamol sulfate Change notification 13.03.2026 Other Bronchospray Autohaler Beclometasone dipropionate (Ph.Eur.) Change notification 13.03.2026 Production issue Junik Metered-Dose Inhaler 100 micrograms Beclometasone dipropionate (Ph.Eur.) Change notification 13.03.2026 Production issue Junik Autohaler 100 micrograms Salbutamol sulfate Change notification 13.03.2026 Other Bronchospray novo Rizatriptan benzoate Change notification 13.03.2026 Other Rizatriptan PUREN 10 mg tablets Risperidone Change notification 13.03.2026 Other Risperidone PUREN 3 mg film-coated tablets Oxycodone hydrochloride (Ph.Eur.) Change notification 13.03.2026 Other Oxycodone hydrochloride Puren 10 mg extended-release tablets Ondansetron hydrochloride dihydrate Change notification 13.03.2026 Production issue Ondansetron Aurobindo 4 mg film-coated tablets Atomoxetine hydrochloride Change notification 13.03.2026 Other Atomoxetine PUREN 10 mg hard capsules Anastrozole Change notification 13.03.2026 Production issue AnastroPUREN 1 mg film-coated tablets Quetiapine fumarate (Ph.Eur.) Change notification 13.03.2026 Production issue Quetiapine – 1 A Pharma 150 mg extended-release tablets Valaciclovir hydrochloride Change notification 13.03.2026 Other Valaciclovir – 1A Pharma 500 mg film-coated tablets Levetiracetam Change notification 13.03.2026 Other Levetiracetam – 1 A Pharma 1500 mg film-coated tablets Atorvastatin calcium trihydrate (Ph. Eur.) Initial report 13.03.2026 Other ATORVASTATIN BASICS 60 mg film-coated tablets Vinorelbine tartrate Change notification 12.03.2026 Production issue Bendarelbin 10 mg/mL concentrate for solution for infusion Prednisolone acetate Initial report 12.03.2026 Production issue Dontisolon D oral paste Prednisolone Initial report 12.03.2026 Production issue Dontisolon D Cylinder Ampoules Clomiphene citrate Initial report 12.03.2026 Production issue Clomifen-ratiopharm 50 mg tablets Tacrolimus monohydrate Change notification 12.03.2026 Other Tacrolimus AL 3 mg extended-release hard capsules Tacrolimus monohydrate Change notification 12.03.2026 Other Tacrolimus AL 0.5 mg extended-release hard capsules Tacrolimus monohydrate Change notification 12.03.2026 Other Tacrolimus AL 1 mg extended-release hard capsules Tacrolimus monohydrate Change notification 12.03.2026 Other Tacrolimus AL 5 mg extended-release hard capsules Fluoxetine hydrochloride Change notification 12.03.2026 Other Fluoxetine Micro Labs 60 mg hard capsules Fluoxetine hydrochloride Change notification 12.03.2026 Other Fluoxetine Micro Labs 30 mg hard capsules Mannitol (Ph.Eur.) Change notification 12.03.2026 Other Bronchitol 40 mg hard capsule with powder for inhalation – OP10(1×10) Methanthelinium bromide Change notification 11.03.2026 Production issue Vagantin RIEMSER Primidone Change notification 11.03.2026 Other Primidone Holsten Amlodipine besylate; Hydrochlorothiazide; Valsartan Initial report 11.03.2026 Other Amlodipine/Valsartan/HCT Holsten 5 mg/160 mg/12.5 mg film-coated tablets Methylphenidate hydrochloride Change notification 11.03.2026 Other Methylphenidate-ratiopharm 20 mg modified-release hard capsules Everolimus Change notification 11.03.2026 Other Everolimus-ratiopharm 2.5 mg tablets Clonidine hydrochloride Change notification 11.03.2026 Production issue Clonidine-ratiopharm 75 Clonidine hydrochloride Change notification 11.03.2026 Production issue Clonidine-ratiopharm 150 Clonidine hydrochloride Change notification 11.03.2026 Production issue Clonidine-ratiopharm 300 (2-Aminoethyl)dihydrogenphosphate calcium salt (1:1) Change notification 11.03.2026 Other Calcium-EAP Buspirone hydrochloride Change notification 10.03.2026 Other Busp 5 mg Pineapple stem bromelain Change notification 10.03.2026 Other NexoBrid Ezetimibe Change notification 10.03.2026 Production issue Ezetimibe Glenmark 10 mg tablets Ezetimibe; Simvastatin Change notification 10.03.2026 Production issue Ezetimibe/Simvastatin Glenmark 10 mg/80 mg tablets Ezetimibe; Simvastatin Change notification 10.03.2026 Production issue Ezetimibe/Simvastatin Glenmark 10 mg/40 mg tablets Ezetimibe; Simvastatin Change notification 10.03.2026 Production issue Ezetimibe/Simvastatin Glenmark 10 mg/20 mg tablets Zonisamide Change notification 10.03.2026 Production issue Zonisamide Glenmark 100 mg hard capsules Quetiapine fumarate (Ph.Eur.) Change notification 10.03.2026 Production issue Quetiapine Glenmark 50 mg extended-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 10.03.2026 Production issue Quetiapine Glenmark 200 mg extended-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 10.03.2026 Production issue Quetiapine Glenmark 300 mg extended-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 10.03.2026 Production issue Quetiapine Glenmark 400 mg extended-release tablets Galantamine hydrobromide Change notification 10.03.2026 Production issue Galantamine Glenmark 24 mg extended-release hard capsules Galantamine hydrobromide Change notification 10.03.2026 Production issue Galantamine Glenmark 16 mg extended-release hard capsules Urapidil Change notification 10.03.2026 Production issue Urapidil Bluefish 90 mg extended-release hard capsules Urapidil Change notification 10.03.2026 Production issue Urapidil Bluefish 30 mg extended-release hard capsules Prednisolone acetate Change notification 10.03.2026 Production issue Prednifluid 10 mg/mL eye drop suspension Methylprednisolone Change notification 10.03.2026 Other Methylprednisolone 8 mg JENAPHARM Dexamethasone dihydrogen phosphate disodium (Ph.Eur.) Initial report 09.03.2026 Other Dexahexal 8 mg Dexamethasone dihydrogen phosphate disodium (Ph.Eur.) Initial report 09.03.2026 Other Dexahexal 4 mg Abiraterone acetate Initial report 09.03.2026 Other Abiraterone HEXAL 1000 mg film-coated tablets Alprazolam Initial report 09.03.2026 Other Alprazolam – 1 A Pharma 1 mg tablets Clindamycin hydrochloride Initial report 09.03.2026 Other ClindaHEXAL 600 mg film-coated tablets Ritonavir Initial report 09.03.2026 Other Ritonavir HEXAL 100 mg film-coated tablets Carbamazepine Change notification 09.03.2026 Production issue Tegretal 200 mg Sufentanil citrate Change notification 09.03.2026 Production issue Sufenta mite Ivermectin Change notification 09.03.2026 Other DRIPONIN 3 mg tablets - 2026.03.09
Active ingredients Message type Date of last message Type of reason AM designation Ritonavir Change notification 06.03.2026 Other Norvir 100 mg film-coated tablets – OP30 Levetiracetam Initial report 06.03.2026 Other LEVETIRACETAM BASICS 1000 mg film-coated tablets Levetiracetam Initial report 06.03.2026 Other LEVETIRACETAM BASICS 250 mg film-coated tablets Fluconazole Initial report 06.03.2026 Other FLUCONAZOLE BASICS 150 mg capsules Candesartan cilexetil Change notification 06.03.2026 Other CANDESARTAN BASICS 16 mg tablets Esomeprazole hemimagnesium Change notification 06.03.2026 Production problem ESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsules Rifampicin Change notification 06.03.2026 Production problem EREMFAT 450 mg Pregabalin Initial report 06.03.2026 Other LYRICA 25 mg hard capsules – OP112(2×56) Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 06.03.2026 Other Atorvastatin Micro Labs 30 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 06.03.2026 Other Atorvastatin Micro Labs 80 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 06.03.2026 Other Atorvastatin Micro Labs 80 mg film-coated tablets Primidone Change notification 05.03.2026 Other Primidone Holsten Hydrocortisone Initial report 05.03.2026 Production problem Efmody Colistimethate sodium Change notification 05.03.2026 Production problem Colistin CF Nitrendipine Change notification 05.03.2026 Other Nitrendipine AbZ 20 mg tablets Quetiapine fumarate (Ph.Eur.) Change notification 05.03.2026 Other Quetiapine AbZ 150 mg prolonged-release tablets Ribavirin Change notification 05.03.2026 Other Ribavirin-ratiopharm 400 mg film-coated tablets Ribavirin Change notification 05.03.2026 Production problem Ribavirin-ratiopharm 200 mg film-coated tablets Quetiapine fumarate (Ph.Eur.) Change notification 05.03.2026 Production problem Quetiapine HEXAL 400 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 05.03.2026 Production problem Quetiapine HEXAL 200 mg prolonged-release tablets Propranolol hydrochloride Change notification 05.03.2026 Other Propra-ratiopharm 10 mg film-coated tablets Nitrendipine Change notification 05.03.2026 Other Nitrendipine-ratiopharm 10 mg tablets Atomoxetine hydrochloride Change notification 05.03.2026 Other Atomoxe – 1 A Pharma 18 mg hard capsules Methylphenidate hydrochloride Change notification 05.03.2026 Other Methylphenidate-ratiopharm 30 mg modified-release hard capsules Quetiapine fumarate (Ph.Eur.) Change notification 05.03.2026 Production problem Quetiapine HEXAL 150 mg prolonged-release tablets Cinacalcet hydrochloride Change notification 05.03.2026 Other Cinacalcet-ratiopharm 30 mg film-coated tablets Doxepin hydrochloride (Ph.Eur.) Change notification 05.03.2026 Other Doxepin-ratiopharm 25 mg film-coated tablets Quetiapine fumarate (Ph.Eur.) Change notification 05.03.2026 Production problem Quetiapine HEXAL 300 mg prolonged-release tablets Pramipexole dihydrochloride monohydrate Change notification 05.03.2026 Other Pramipexole – 1 A Pharma 0.26 mg prolonged-release tablets Thioctic acid trometamol salt (1:1) Change notification 05.03.2026 Other Thioctacid 600 T Clonidine hydrochloride Change notification 05.03.2026 Other Clonidine-ratiopharm 300 Clonidine hydrochloride Change notification 05.03.2026 Other Clonidine-ratiopharm 150 Clonidine hydrochloride Change notification 05.03.2026 Other Clonidine-ratiopharm 75 Amlodipine besylate; Hydrochlorothiazide; Valsartan Change notification 05.03.2026 Other Amlodipine/Valsartan/HCT Holsten 10 mg/160 mg/12.5 mg film-coated tablets Carmustine Initial report 04.03.2026 Production problem Carmustine-ratiopharm Busulfan Initial report 04.03.2026 Production problem Busulfan-ratiopharm 6 mg/ml concentrate for solution for infusion Fluorouracil Change notification 04.03.2026 Other Fluorouracil PhaRes 50 mg/ml solution for injection Deferasirox Change notification 04.03.2026 Other Deferasirox Mylan 180 mg film-coated tablets Nitrendipine Change notification 04.03.2026 Other Nitrendipine AL 10 Nitrendipine Change notification 04.03.2026 Other Nitrendipine AL 20 Rivaroxaban Initial report 03.03.2026 Other Xarelto 1 mg/ml granules for oral suspension Aflibercept Change notification 03.03.2026 Other MYNZEPLI Primidone Change notification 03.03.2026 Production problem Mylepsinum Quetiapine fumarate (Ph.Eur.) Change notification 03.03.2026 Other Quetiapine AL 50 mg prolonged-release tablets Etoricoxib Initial report 03.03.2026 Other Etorican 120 mg film-coated tablets Terazosin hydrochloride dihydrate Change notification 03.03.2026 Other Heitrin 2 mg Oxycodone hydrochloride (Ph.Eur.) Change notification 03.03.2026 Other Oxycan uno 10 mg prolonged-release tablets Sumatriptan succinate Change notification 03.03.2026 Production problem MIGRAPEN 3 mg/0.5 ml solution for injection in a pre-filled pen Tirofiban hydrochloride monohydrate Initial report 03.03.2026 Production problem Aggrastat 250 micrograms/ml concentrate for solution for infusion Quetiapine fumarate (Ph.Eur.) Change notification 03.03.2026 Other Quetiapine hormosan 200 mg prolonged-release tablets Tobramycin Initial report 03.03.2026 Other TOBI Podhaler 28 mg hard capsules with powder for inhalation – OP224(4×56) Atomoxetine hydrochloride Change notification 03.03.2026 Production problem Atomoxetine beta 80 mg hard capsules Fluoxetine hydrochloride Change notification 03.03.2026 Other Fluoxetine beta 20 Epinephrine/adrenaline Change notification 03.03.2026 Production problem Anapen 500 micrograms solution for injection Hydrochlorothiazide; losartan potassium Change notification 03.03.2026 Other LosarHCT-Denk 50 mg/12.5 mg film-coated tablets Phenylephrine hydrochloride Change notification 03.03.2026 Production problem Neosynephrine-POS 5% Proxymetacaine hydrochloride Change notification 03.03.2026 Production problem Proparacaine-POS 0.5% Human immunoglobulin G Initial report 02.03.2026 Production problem IQYMUNE Human immunoglobulin G Initial report 02.03.2026 Production problem IQYMUNE Carbamazepine Change notification 02.03.2026 Other Timonil Syrup Fenoterol hydrobromide Initial report 02.03.2026 Production problem Intrapartum obstetricians Etanercept Change notification 02.03.2026 Other Nepexto 50 mg solution for injection in a pre-filled syringe - 2026.03.03
Active ingredients Message type Date of last message Type of reason AM designation Fibrinogen, human Change notification 27.02.2026 Production problem Haemocomplettan P 2g Fibrinogen, human Change notification 27.02.2026 Production problem Haemocomplettan P 1g Atorvastatin calcium trihydrate (Ph.Eur.) Initial report 27.02.2026 Other Atorvastatin Micro Labs 80 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 27.02.2026 Other Atorvastatin Micro Labs 30 mg film-coated tablets Efavirenz; emtricitabine; tenofovir disoproxil Initial report 27.02.2026 Production problem Efavirenz/emtricitabine/tenofovir disoproxil Heumann 600 mg/200 mg/245 mg film-coated tablets Mesalazine Initial report 27.02.2026 Other Asacol 1600 mg modified-release tablet Arsenic(III) oxide Change notification 27.02.2026 Other TRISENOX 2 mg/ml concentrate for solution for infusion Valaciclovir hydrochloride Change notification 27.02.2026 Other Valaciclovir – 1A Pharma 500 mg film-coated tablets Dexketoprofen trometamol Change notification 27.02.2026 Production problem Sympal inject 50 mg solution for injection/infusion Quetiapine fumarate (Ph.Eur.) Change notification 27.02.2026 Production problem Quetiapine – 1 A Pharma 400 mg prolonged-release tablets Rifampicin sodium Change notification 27.02.2026 Other Eremfat i.v. 600mg Oxcarbazepine Change notification 27.02.2026 Other Oxcarbazepine – 1 A Pharma 60 mg/ml oral suspension Imiquimod Initial report 27.02.2026 Other AKSUNIM 50 mg/g cream Oxytocin Change notification 27.02.2026 Production problem Oxytocin 3 I.E. Hexal Esomeprazole hemimagnesium Change notification 26.02.2026 Production problem ESOMEPRAZOLE BASICS 40 mg gastro-resistant hard capsules Esomeprazole hemimagnesium Change notification 26.02.2026 Production problem ESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsules Ezetimibe; simvastatin Change notification 26.02.2026 Production problem EZETIMIBE/SIMVA BASICS 10 mg/10 mg tablets Ezetimibe; simvastatin Change notification 26.02.2026 Production problem EZETIMIBE/SIMVA BASICS 10 mg/20 mg tablets Ezetimibe; simvastatin Change notification 26.02.2026 Production problem EZETIMIBE/SIMVA BASICS 10 mg/40 mg tablets Ezetimibe; simvastatin Change notification 26.02.2026 Production problem EZETIMIB/SIMVA BASICS 10 mg/80 mg tablets Isotretinoin Change notification 26.02.2026 Other ISOTRETINOIN BASICS 20 mg soft capsules Isotretinoin Change notification 26.02.2026 Other ISOTRETINOIN BASICS 10 mg soft capsules Ciprofloxacin hydrochloride monohydrate Change notification 26.02.2026 Other CIPRO BASICS 250 mg film-coated tablets Ciprofloxacin hydrochloride monohydrate Change notification 26.02.2026 Other CIPRO BASICS 750 mg film-coated tablets Ciprofloxacin hydrochloride monohydrate Change notification 26.02.2026 Other CIPRO BASICS 500 mg film-coated tablets Candesartan cilexetil Change notification 26.02.2026 Other CANDESARTAN BASICS 8 mg tablets Candesartan cilexetil Change notification 26.02.2026 Other CANDESARTAN BASICS 4 mg tablets Candesartan cilexetil Change notification 26.02.2026 Other CANDESARTAN BASICS 32 mg tablets Candesartan cilexetil Change notification 26.02.2026 Other CANDESARTAN BASICS 16 mg tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 26.02.2026 Other ATORVASTATIN BASICS 30 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 26.02.2026 Other ATORVASTATIN BASICS 40 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 26.02.2026 Other ATORVASTATIN BASICS 80 mg film-coated tablets Tobramycin Initial report 26.02.2026 Other Tobramycin SUN 300 mg solution for nebulizer Lacosamide Change notification 26.02.2026 Other Vimpat 100 mg film-coated tablets – OP14 Hydrochlorothiazide; Losartan potassium Initial report 26.02.2026 Other LosarHCT-Denk 50 mg/12.5 mg film-coated tablets Imatinib mesylate Change notification 26.02.2026 Other Imatinib Denk 100 mg film-coated tablets Quetiapine fumarate (Ph.Eur.) Change notification 26.02.2026 Other Seroquel Prolong 200 mg prolonged-release tablets Clonidine hydrochloride Initial report 26.02.2026 Other Catapresan 150 Paliperidone palmitate Change notification 26.02.2026 Other Niapelf Sodium valproate; valproic acid Initial report 26.02.2026 Other Valpro AL 300 mg prolonged-release tablets Eletriptan hydrobromide Initial report 26.02.2026 Production problem Eletriptan Bluefish 20 mg film-coated tablets Alanine; Arginine; Glycine; Histidine; Isoleucine; Leucine; Lysine acetate; Methionine; Phenylalanine; Proline; Serine; Taurine; Threonine; Tryptophan; Tyrosine; Valine Initial report 26.02.2026 Other Aminoven 10% Acetylcysteine; alanine; arginine; acetic acid 99%; glycine; histidine; isoleucine; leucine; lysine acetate; methionine; phenylalanine; proline; serine; threonine; tryptophan; valine Initial report 26.02.2026 Other Aminosteril N-Hepa 8% Acetylcysteine; alanine; arginine; glycine; histidine; isoleucine; L-malic acid; leucine; lysine acetate; methionine; N-acetyl tyrosine (Ph.Eur.); phenylalanine; proline; serine; taurine; threonine; tryptophan; valine Initial report 26.02.2026 Other Aminoven infant 10% Prednisolone Initial report 26.02.2026 Other Prednisolone AL 20 mg tablets Nilotinib hydrochloride dihydrate Initial report 26.02.2026 Other Nilotinib AL 50 mg hard capsules Calcium folinate hydrate Change notification 26.02.2026 Production problem Calcium folinate onkovis 10 mg/ml solution for injection Rosuvastatin hemicalcium Change notification 25.02.2026 Other Rosuvastatin Aristo 5 mg film-coated tablets Dexamethasone dihydrogen phosphate disodium (Ph.Eur.) Change notification 25.02.2026 Other Dexafluid 1 mg/ml eye drops Betamethasone dipropionate (Ph.Eur.); calcipotriol monohydrate Initial report 25.02.2026 Other Calcipotriol comp. 50 micrograms/g + 0.5 mg/g gel Quetiapine fumarate (Ph.Eur.) Change notification 25.02.2026 Other Quetiapine-neuraxpharm 600 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 25.02.2026 Other Quetiapine-neuraxpharm 400 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 25.02.2026 Other Quetiapine-neuraxpharm 300 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 25.02.2026 Other Quetiapine-neuraxpharm 200 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 25.02.2026 Other Quetiapine-neuraxpharm 150 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 25.02.2026 Other Quetiapine-neuraxpharm 50 mg prolonged-release tablets Propranolol hydrochloride Initial report 25.02.2026 Other Propranolol AL 80 Pregabalin Initial report 25.02.2026 Other Pregabalin Aurobindo 200 mg hard capsules Quetiapine fumarate (Ph.Eur.) Change notification 25.02.2026 Other Seroquel Prolong 150 mg prolonged-release tablets Risperidone Initial report 25.02.2026 Other Risperidone Aurobindo 1 mg film-coated tablets Flutamide Change notification 25.02.2026 Other Flutamide AL 250 Sumatriptan succinate Initial report 25.02.2026 Other Sumatriptan Aurobindo 50 mg tablets Rizatriptan benzoate Initial report 25.02.2026 Other Rizatriptan Aurobindo 10 mg tablets Lamotrigine Change notification 25.02.2026 Production problem Lamotrigine Aurobindo 5 mg tablets for oral suspension Dutasteride; tamsulosin hydrochloride Change notification 25.02.2026 Production problem Dutasteride/tamsulosin PUREN 0.5 mg/0.4 mg hard capsules Buprenorphine hydrochloride Change notification 25.02.2026 Other Buprenorphine PUREN 8 mg sublingual tablets Propranolol hydrochloride Initial report 25.02.2026 Other Propranolol-CT 80 mg film-coated tablets Propranolol hydrochloride Initial report 25.02.2026 Other Propranolol-CT 40 mg film-coated tablets Arsenic(III) oxide Change notification 25.02.2026 Production problem Arsenic trioxide STADA 1 mg/ml concentrate for solution for infusion Tranexamic acid Change notification 24.02.2026 Production problem Tranexamic acid PUREN 100 mg/ml solution for injection Risedronate sodium 2.5 hydrate (Ph.Eur.) Change notification 24.02.2026 Other Risedronate Aurobindo once weekly 35 mg film-coated tablets Risperidone Change notification 24.02.2026 Other Risperidone PUREN 3 mg film-coated tablets Flurazepam Change notification 24.02.2026 Production problem Flurazepam real Tropicamide Change notification 24.02.2026 Production problem Mydriaticum Stulln UD Quetiapine fumarate (Ph.Eur.) Initial report 24.02.2026 Other Seroquel Prolong 50 mg prolonged-release tablets Ritonavir Change notification 24.02.2026 Other Ritonavir Viatris 100 mg film-coated tablets – OP30 Ethambutol dihydrochloride Initial report 24.02.2026 Production problem EMB-FATOL 500 mg Valaciclovir hydrochloride Initial report 24.02.2026 Production problem Valaciclovir Aurobindo 500 mg film-coated tablets Ethambutol dihydrochloride Initial report 24.02.2026 Other EMB-FATOL 100 mg Thioctic acid trometamol salt (1:1) Change notification 24.02.2026 Other Thioctacid 600 T Telmisartan Initial report 23.02.2026 Other Telmisartan Micro Labs 20 mg tablets Entecavir Initial report 23.02.2026 Production problem Baraclude 0.5 mg film-coated tablets – OP90(90×1) Doxorubicin hydrochloride Change notification 23.02.2026 Production problem DOXO-cell 150 mg solution for injection Doxorubicin hydrochloride Change notification 23.02.2026 Production problem DOXO-cell 50 mg solution for injection Mivacurium chloride Change notification 23.02.2026 Production problem Mivacron 20mg Amlodipine besylate; Hydrochlorothiazide; Valsartan Initial report 23.02.2026 Other Amlodipine/Valsartan/HCT Holsten 10 mg/160 mg/25 mg film-coated tablets Primidone Change notification 23.02.2026 Other Primidone Holsten - 2026.02.23
Active ingredients Message type Date of last message Type of reason AM designation Acetylcholine chloride Change notification 20.02.2026 Production problem Miochol-E powder and solvent for the preparation of an instillation solution for intraocular use Sodium (methylprednisolone-21-succinate) Change notification 19.02.2026 Other Urbason solubile forte 1000 mg Beclomethasone dipropionate (Ph.Eur.) Initial report 19.02.2026 Production problem Junik metered dose inhaler 100 micrograms Quetiapine fumarate (Ph.Eur.) Change notification 19.02.2026 Other Seroquel Prolong 300 mg prolonged-release tablets Beclomethasone dipropionate (Ph.Eur.) Initial report 19.02.2026 Production problem Junik Autohaler 100 micrograms Acetylcysteine; alanine; arginine; acetic acid 99%; glycine; histidine; isoleucine; leucine; lysine acetate; methionine; phenylalanine; proline; serine; threonine; tryptophan; valine Initial report 19.02.2026 Production problem Aminosteril N-Hepa 8% Amidotrizoate meglumine; sodium amidotrizoate Initial report 19.02.2026 Other Gastrografin Salbutamol sulfate Change notification 19.02.2026 Other Bronchospray Autohaler Isosorbide mononitrate Change notification 19.02.2026 Production problem ISMN STADA 50 mg hard capsules, delayed release Isosorbide mononitrate Change notification 19.02.2026 Production problem ISMN STADA 20 mg tablets Aprepitant Change notification 19.02.2026 Production problem Aprepitant STADA 125 mg and 80 mg hard capsules Aprepitant Change notification 19.02.2026 Production problem Aprepitant STADA 80 mg hard capsules Atomoxetine hydrochloride Change notification 19.02.2026 Other Atomoxetine PUREN 10 mg hard capsules Escitalopram oxalate Initial report 19.02.2026 Other Escitalopram Aurobindo 20 mg film-coated tablets Nitrendipine Change notification 19.02.2026 Other Nitrendipine AbZ 10 mg tablets Clonidine hydrochloride Change notification 19.02.2026 Other Clonidine-ratiopharm 300 Clonidine hydrochloride Change notification 19.02.2026 Other Clonidine-ratiopharm 150 Clonidine hydrochloride Change notification 19.02.2026 Other Clonidine-ratiopharm 75 Pantoprazole sodium sesquihydrate Initial report 19.02.2026 Other Pantoprazole Denk 40 mg gastro-resistant tablets Alprazolam Change notification 19.02.2026 Other Alprazolam-ratiopharm 1.0 mg tablets Quetiapine fumarate (Ph.Eur.) Change notification 19.02.2026 Other Quetiapine-ratiopharm 300 mg prolonged-release tablets Propranolol hydrochloride Change notification 19.02.2026 Other Propra-ratiopharm 80 mg film-coated tablets Propranolol hydrochloride Change notification 19.02.2026 Other Propra-ratiopharm 40 mg film-coated tablets Colistimethate sodium Change notification 19.02.2026 Production problem Colistin CF Ipratropium bromide (Ph.Eur.) Change notification 19.02.2026 Production problem Ipratropium Teva 250 micrograms/1 ml solution for nebulizer Aprepitant Change notification 19.02.2026 Production problem Aprepitant STADA 125 mg hard capsules Aciclovir Initial report 19.02.2026 Production problem Aciclovir AbZ Cold sore cream Aciclovir Initial report 19.02.2026 Production problem Aciclovir-ratiopharm 50 mg/g cream Oxytocin Change notification 19.02.2026 Production problem Oxytocin 3 I.E. Hexal Pramipexole dihydrochloride monohydrate Change notification 19.02.2026 Other Pramipexole – 1 A Pharma 0.26 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 19.02.2026 Production problem Quetiapine HEXAL 150 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 19.02.2026 Production problem Quetiapine – 1 A Pharma 150 mg prolonged-release tablets Thioctic acid trometamol salt (1:1) Change notification 19.02.2026 Other Thioctacid 600 T Quetiapine fumarate (Ph.Eur.) Change notification 19.02.2026 Production problem Quetiapine – 1 A Pharma 50 mg prolonged-release tablets Methyldopa (Ph.Eur.) Change notification 18.02.2026 Production problem Methyldopa STADA 250 mg film-coated tablet Atorvastatin calcium trihydrate (Ph.Eur.) Initial report 18.02.2026 Other Atorvastatin Micro Labs 80 mg film-coated tablets Von Willebrand factor Change notification 18.02.2026 Other WILLFACT 1000 IU Primidone Change notification 17.02.2026 Other Primidone Holsten Methylprednisolone Initial report 17.02.2026 Other Methylprednisolone 8 mg JENAPHARM Sitagliptin hydrochloride monohydrate Initial report 17.02.2026 Other Sitagliptin PUREN 50 mg film-coated tablets Mirtazapine Initial report 17.02.2026 Other Mirtazapine Aurobindo 30 mg film-coated tablets Levetiracetam Initial report 17.02.2026 Other Levetiracetam Aurobindo 750 mg film-coated tablets Tamsulosin hydrochloride Initial report 17.02.2026 Other Tamsulosin Aurobindo 0.4 mg prolonged-release capsules Methylphenidate hydrochloride Change notification 17.02.2026 Other Methylphenidate hydrochloride-neuraxpharm 27 mg prolonged-release tablets Tamsulosin hydrochloride Change notification 17.02.2026 Other Tamsulosin hydrochloride PUREN 0.4 mg prolonged-release capsules Urapidil Initial report 17.02.2026 Production problem Urapidil PUREN 90 mg prolonged-release capsules Teriflunomide Initial report 17.02.2026 Production problem Teriflunomide PUREN 14 mg film-coated tablets Trandolapril; verapamil hydrochloride Change notification 17.02.2026 Other Tarka 180 mg/2 mg modified-release tablets Fluoxetine hydrochloride Change notification 16.02.2026 Other Fluoxetine Micro Labs 30 mg hard capsules Fluoxetine hydrochloride Change notification 16.02.2026 Other Fluoxetine Micro Labs 60 mg hard capsules Methylphenidate hydrochloride Change notification 16.02.2026 Other METHYLPHENIDATE 5 mg tablets Lacosamide Initial report 16.02.2026 Other Vimpat 100 mg film-coated tablets – OP14 Lorazepam Change notification 16.02.2026 Other Tavor 2.5 mg Expidet Terazosin hydrochloride dihydrate Change notification 16.02.2026 Other Heitrin 2 mg Terazosin hydrochloride dihydrate Change notification 16.02.2026 Other Heitrin 1 mg Terazosin hydrochloride dihydrate Change notification 16.02.2026 Other Heitrin 5mg Ritonavir Initial report 16.02.2026 Other Ritonavir Viatris 100 mg film-coated tablets – OP30 Flurazepam Initial report 16.02.2026 Production problem Flurazepam real - 2026.02.16
Active ingredients Message type Date of last message Type of reason AM designation Trimipramine mesylate Change notification 13.02.2026 Other Trimipramine – 1 A Pharma 40 mg/ml oral drops, solution Alprazolam Change notification 13.02.2026 Other Alprazolam – 1 A Pharma 0.5 mg tablets Chlortalidone Change notification 13.02.2026 Other Chlortalidone HEXAL 12.5 mg tablets Dexketoprofen trometamol Change notification 13.02.2026 Production problem Sympal inject 50 mg injection/infusion solution Anastrozole Change notification 13.02.2026 Production problem AnastroPUREN 1 mg film-coated tablets Isoniazid Change notification 13.02.2026 Other Isozid 100 mg Potassium iodide; levothyroxine sodium Change notification 13.02.2026 Other Thyronajod 75 Henning Potassium iodide; levothyroxine sodium Initial report 13.02.2026 Other Thyronajod 100 Henning Atorvastatin calcium trihydrate (Ph.Eur.) Initial report 12.02.2026 Other ATORVASTATIN BASICS 60 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 12.02.2026 Other ATORVASTATIN BASICS 30 mg film-coated tablets Ciprofloxacin hydrochloride monohydrate Initial report 12.02.2026 Other CIPRO BASICS 500 mg film-coated tablets Esomeprazole hemimagnesium Change notification 12.02.2026 Production problem ESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsules Candesartan cilexetil Change notification 12.02.2026 Other CANDESARTAN BASICS 4 mg tablets Candesartan cilexetil Change notification 12.02.2026 Other CANDESARTAN BASICS 8 mg tablets Candesartan cilexetil Change notification 12.02.2026 Other CANDESARTAN BASICS 32 mg tablets Ciprofloxacin hydrochloride monohydrate Change notification 12.02.2026 Other CIPRO BASICS 250 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Initial report 12.02.2026 Other ATORVASTATIN BASICS 40 mg film-coated tablets Esomeprazole hemimagnesium Change notification 12.02.2026 Production problem ESOMEPRAZOLE BASICS 40 mg gastro-resistant hard capsules Tacrolimus monohydrate Initial report 12.02.2026 Production problem Tacpan 5 mg hard capsules Zidovudine Initial report 12.02.2026 Production problem Zidovudine Aurobindo 250 mg hard capsules Ondansetron hydrochloride dihydrate Initial report 12.02.2026 Production problem Ondansetron Aurobindo 4 mg film-coated tablets Escitalopram oxalate Initial report 12.02.2026 Other Escitalopram Aurobindo 10 mg film-coated tablets Duloxetine hydrochloride Initial report 12.02.2026 Other Duloxetine Aurobindo 60 mg gastro-resistant hard capsules Venlafaxine hydrochloride Initial report 12.02.2026 Production problem Venlafaxine Aurobindo 75 mg hard capsule, delayed release Dutasteride; tamsulosin hydrochloride Initial report 12.02.2026 Production problem Dutasteride/tamsulosin PUREN 0.5 mg/0.4 mg hard capsules Deferoxamine mesylate Initial report 12.02.2026 Production problem Deferoxamine mesylate 2 g powder for solution for injection or infusion Amiodarone hydrochloride Initial report 12.02.2026 Production problem Amiodarone Aurobindo 200 mg tablets Paliperidone palmitate Change notification 12.02.2026 Other Paliperidone AL 25 mg depot injection suspension in a pre-filled syringe Dexamethasone acetate (Ph.Eur.); lidocaine hydrochloride monohydrate Initial report 11.02.2026 Production problem Supertendin 5 Dexamethasone acetate (Ph.Eur.); lidocaine hydrochloride monohydrate Initial report 11.02.2026 Production problem Supertendin 10 Lidocaine hydrochloride monohydrate Change notification 10.02.2026 Other Xylocaine Gel 2% Estriol Initial report 10.02.2026 Other Ovestin 1 mg tablets Sertraline hydrochloride Change notification 10.02.2026 Production problem Sertraline-neuraxpharm 200 mg film-coated tablets Sertraline hydrochloride Change notification 10.02.2026 Production problem Sertraline-neuraxpharm 150 mg film-coated tablets Levetiracetam Change notification 10.02.2026 Production problem Levetiracetam Holsten 750 mg film-coated tablets Human insulin ((with manufacturing details)) Initial report 09.02.2026 Other Huminsulin Basal (NPH) 100 100 IU/ml injection suspension in vial Thioctic acid trometamol salt (1:1) Change notification 09.02.2026 Other Thioctacid 600 T Prednisolone acetate Change notification 09.02.2026 Production problem Prednifluid 10 mg/ml eye drop suspension Terazosin hydrochloride dihydrate Change notification 09.02.2026 Other Heitrin 5 mg Terazosin hydrochloride dihydrate Change notification 09.02.2026 Other Heitrin 1mg Terazosin hydrochloride dihydrate Change notification 09.02.2026 Other Heitrin 2 mg Dapson Initial report 09.02.2026 Other Dapsone Zentiva 50 mg tablets Mometasone furoate (Ph.Eur.) Change notification 09.02.2026 Production problem Momecutan solution Isoniazid Change notification 09.02.2026 Other Isozid 50 mg Rifampicin sodium Change notification 09.02.2026 Other Eremfat i.v. 600mg - 2026.02.09
Active ingredients Message type Date of last message Type of reason AM designation Salbutamol sulfate Initial report 08.02.2026 Other Sultanol forte ready-to-use inhalation solution Isotretinoin Change notification 06.02.2026 Other ISOTRETINOIN BASICS 10 mg soft capsules Isotretinoin Initial report 06.02.2026 Other ISOTRETINOIN BASICS 20 mg soft capsules Mitomycin Change notification 06.02.2026 Other Mitem 20mg Epoetin alfa Initial report 06.02.2026 Other Epoetin alfa HEXAL 40000 IU/1 ml solution for injection in pre-filled syringe – OP6 Ivermectin Change notification 06.02.2026 Other DRIPONIN 3 mg tablets Oxcarbazepine Change notification 06.02.2026 Other Oxcarbazepine – 1 A Pharma 60 mg/ml oral suspension Pramipexole dihydrochloride monohydrate Change notification 06.02.2026 Other Pramipexole – 1 A Pharma 0.26 mg prolonged-release tablets Dexamethasone dihydrogen phosphate disodium (Ph.Eur.) Initial report 05.02.2026 Other Dexabene Ibuprofen Change notification 05.02.2026 Production problem Ibuprofen PUREN 600 mg film-coated tablets Docetaxel Change notification 05.02.2026 Production problem Docetaxel Aurobindo 20 mg/ml concentrate for solution for infusion Buprenorphine hydrochloride Change notification 05.02.2026 Other Buprenorphine PUREN 8 mg sublingual tablets Anastrozole Change notification 05.02.2026 Production problem AnastroPUREN 1 mg film-coated tablets Quetiapine fumarate (Ph.Eur.) Change notification 05.02.2026 Production problem Quetiapine beta 150 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 05.02.2026 Production problem Quetiapine beta 200 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 05.02.2026 Production problem Quetiapine beta 300 mg prolonged-release tablets Atomoxetine hydrochloride Change notification 05.02.2026 Production problem Atomoxetine beta 18 mg hard capsules Fluoxetine hydrochloride Change notification 05.02.2026 Other Fluoxetine beta 20 Atomoxetine hydrochloride Change notification 05.02.2026 Production problem Atomoxetine beta 80 mg hard capsules Aprepitant Change notification 05.02.2026 Production problem Aprepitant beta 125 mg and 80 mg hard capsules Tacrolimus monohydrate Initial report 04.02.2026 Other Takrozem 1 mg/g ointment Lidocaine hydrochloride monohydrate Change notification 04.02.2026 Other Xylocaine Gel 2% Alprostadil Initial report 04.02.2026 Other Prostavasin 20 µg Gabapentin Change notification 04.02.2026 Production problem Gabapentin Holsten 600 mg film-coated tablets Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y) Change notification 04.02.2026 Other Ferrlecit 40 mg Risperidone Change notification 04.02.2026 Production problem Risperidone-ratiopharm 50 mg powder and solvent for the preparation of a depot injection suspension Risperidone Change notification 04.02.2026 Production problem Risperidone-ratiopharm 37.5 mg powder and solvent for the preparation of a depot injection suspension Risperidone Change notification 04.02.2026 Production problem Risperidone-ratiopharm 25 mg powder and solvent for the preparation of a depot injection suspension Candesartan cilexetil Initial report 03.02.2026 Other ATACAND 16 mg Crisantaspase Change notification 03.02.2026 Other Erwinase 10,000 IU/vial powder for the preparation of an injection/infusion solution Calcitriol Initial report 03.02.2026 Other Renatriol 0.25 µg Calcitriol Initial report 03.02.2026 Other Calcitriol KyraMed 0.25 micrograms Fluoxetine hydrochloride Change notification 03.02.2026 Other Fluoxetine Micro Labs 30 mg hard capsules Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 03.02.2026 Other Atorvastatin Micro Labs 60 mg film-coated tablets Prednisolone acetate Initial report 03.02.2026 Production problem Predni-POS 0.5% Propranolol hydrochloride Change notification 03.02.2026 Other Propra-ratiopharm 10 mg film-coated tablets Methylphenidate hydrochloride Initial report 03.02.2026 Other Methylphenidate-ratiopharm 30 mg modified-release hard capsules Methylphenidate hydrochloride Initial report 03.02.2026 Other Methylphenidate-ratiopharm 20 mg modified-release hard capsules Ipratropium bromide (Ph.Eur.) Change notification 03.02.2026 Production problem Ipratropium Teva 250 micrograms/1 ml solution for nebulizer Quetiapine fumarate (Ph.Eur.) Change notification 03.02.2026 Other Quetiapine AbZ 150 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 03.02.2026 Other Quetiapine-ratiopharm 300 mg prolonged-release tablets Everolimus Change notification 03.02.2026 Other Everolimus-ratiopharm 5 mg tablets Everolimus Change notification 03.02.2026 Other Everolimus-ratiopharm 2.5 mg tablets Doxepine hydrochloride (Ph.Eur.) Change notification 03.02.2026 Other Doxepin-ratiopharm 25 mg film-coated tablets Alprazolam Change notification 03.02.2026 Other Alprazolam-ratiopharm 1.0 mg tablets Prednisolone acetate Change notification 03.02.2026 Production problem Predni-POS 1% Proxymetacaine hydrochloride Change notification 03.02.2026 Production problem Proparacaine-POS 0.5% Fluorometholone Change notification 03.02.2026 Production problem Fluoropos Gentamicin sulfate Change notification 03.02.2026 Production problem Gentamicin-POS Salbutamol sulfate Change notification 02.02.2026 Other Bronchospray novo - 2026.02.02
Active ingredients Message type Date of last message Type of reason AM designation Atomoxetine hydrochloride Change notification 30.01.2026 Other Atomoxe – 1 A Pharma 10 mg hard capsules Valaciclovir hydrochloride Change notification 30.01.2026 Other Valaciclovir – 1A Pharma 500 mg film-coated tablets Salbutamol sulfate Change notification 30.01.2026 Other SalbuHEXAL N metered-dose inhaler Salbutamol sulfate Change notification 30.01.2026 Other Salbutamol – 1 A Pharma 0.1 mg pressurized gas inhalation, suspension Lorazepam Change notification 30.01.2026 Other Tavor 2.5 mg Expidet Quetiapine fumarate (Ph.Eur.) Change notification 30.01.2026 Production problem Quetiapine – 1 A Pharma 600 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 30.01.2026 Production problem Quetiapine – 1 A Pharma 50 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 30.01.2026 Production problem Quetiapine – 1 A Pharma 300 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 30.01.2026 Production problem Quetiapine – 1 A Pharma 200 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 30.01.2026 Production problem Quetiapine – 1 A Pharma 150 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 30.01.2026 Production problem Quetiapine HEXAL 50 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 30.01.2026 Production problem Quetiapine HEXAL 400 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 30.01.2026 Production problem Quetiapine HEXAL 200 mg prolonged-release tablets Methylphenidate hydrochloride Change notification 30.01.2026 Other Methylphenidate hydrochloride HEXAL 36 mg prolonged-release tablets Levetiracetam Change notification 30.01.2026 Other Levetiracetam – 1 A Pharma 1500 mg film-coated tablets Ciprofloxacin hydrochloride (1:1) 1 H<2>O Change notification 30.01.2026 Other Ciprohexal 100 mg Ciprofloxacin hydrochloride (1:1) 1 H<2>O Change notification 30.01.2026 Other Cipro-1 A Pharma 100 mg Trimipramine mesylate Change notification 30.01.2026 Other Trimipramine – 1 A Pharma 40 mg/ml Oral drops, solution Oxytocin Change notification 30.01.2026 Production problem Oxytocin 3 I.E. Hexal Insulin glargine Change notification 30.01.2026 Other Semglee Alprazolam Change notification 30.01.2026 Other Alprazolam – 1 A Pharma 0.5 mg tablets Chlortalidone Change notification 30.01.2026 Other Chlortalidone HEXAL 12.5 mg tablets Dinoprostone Change notification 30.01.2026 Other Propess 10 mg vaginal delivery system Rifampicin Change notification 30.01.2026 Production problem Eremfat syrup Ezetimibe; simvastatin Change notification 30.01.2026 Production problem EZETIMIB/SIMVA BASICS 10 mg/80 mg tablets Ezetimibe; simvastatin Change notification 30.01.2026 Production problem EZETIMIB/SIMVA BASICS 10 mg/40 mg tablets Ezetimibe; simvastatin Change notification 30.01.2026 Production problem EZETIMIB/SIMVA BASICS 10 mg/20 mg tablets Ezetimibe; simvastatin Change notification 30.01.2026 Production problem EZETIMIB/SIMVA BASICS 10 mg/10 mg tablets Ciprofloxacin hydrochloride monohydrate Change notification 30.01.2026 Other CIPRO BASICS 750 mg film-coated tablets Ciprofloxacin hydrochloride monohydrate Change notification 30.01.2026 Other CIPRO BASICS 250 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 30.01.2026 Other ATORVASTATIN BASICS 30 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 30.01.2026 Other ATORVASTATIN BASICS 20 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 30.01.2026 Other ATORVASTATIN BASICS 10 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 30.01.2026 Other ATORVASTATIN BASICS 80 mg film-coated tablets Candesartan cilexetil Change notification 30.01.2026 Other CANDESARTAN BASICS 32 mg tablets Candesartan cilexetil Change notification 30.01.2026 Other CANDESARTAN BASICS 16 mg tablets Candesartan cilexetil Change notification 30.01.2026 Other CANDESARTAN BASICS 8 mg tablets Candesartan cilexetil Change notification 30.01.2026 Other CANDESARTAN BASICS 4 mg tablets Esomeprazole hemimagnesium Change notification 30.01.2026 Production problem ESOMEPRAZOLE BASICS 40 mg gastro-resistant hard capsules Esomeprazole hemimagnesium Change notification 30.01.2026 Production problem ESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsules Quetiapine fumarate (Ph.Eur.) Initial report 30.01.2026 Other Seroquel Prolong 400 mg prolonged-release tablets Clonidine hydrochloride Initial report 29.01.2026 Other Catapresan 300 Pramipexole dihydrochloride monohydrate Change notification 29.01.2026 Other Pramipexole-ratiopharm 0.52 mg prolonged-release tablets Folic acid hydrate (with information on water content (1:x)) Initial report 29.01.2026 Production problem Folsan 0.4 mg Methyldopa (Ph.Eur.) Initial report 29.01.2026 Production problem Presinol 500 Prednicarbat Initial report 29.01.2026 Other Prednitop Crinale Mometasone furoate (Ph.Eur.) Change notification 29.01.2026 Production problem Momecutan solution Imatinib mesylate Initial report 28.01.2026 Other Imatinib Denk 100 mg film-coated tablets Amlodipine besylate; Perindopril tert-butylamine Change notification 28.01.2026 Other Perindopril/Amlodipine Denk 4 mg/10 mg tablets Amlodipine besylate; Perindopril tert-butylamine Change notification 28.01.2026 Other Perindopril/Amlodipine Denk 8 mg/10 mg tablets Rifampicin sodium Change notification 28.01.2026 Other Eremfat i.v. 600mg Quetiapine fumarate (Ph.Eur.) Change notification 28.01.2026 Other Quetiapine AL 50 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 28.01.2026 Other Quetiapine AL 150 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 28.01.2026 Other Quetiapine AL 300 mg prolonged-release tablets Aprepitant Change notification 28.01.2026 Other Aprepitant AL 80 mg hard capsules Aprepitant Change notification 28.01.2026 Other Aprepitant AL 125 mg hard capsules Nitrendipine Change notification 28.01.2026 Other Nitrendipine AL 20 Nitrendipine Change notification 28.01.2026 Other Nitrendipine AL 10 Methylphenidate hydrochloride Change notification 28.01.2026 Other METHYLPHENIDATE 20 mg tablets Thioctic acid trometamol salt (1:1) Initial report 28.01.2026 Other Thioctacid 600 T Duloxetine hydrochloride Initial report 27.01.2026 Production problem Duloxetine Zentiva 30 mg gastro-resistant hard capsules Duloxetine hydrochloride Initial report 27.01.2026 Production problem Duloxetine Zentiva 60 mg gastro-resistant hard capsules Doxepin hydrochloride (Ph.Eur.) Change notification 27.01.2026 Other Doxepin 50 Holsten Gabapentin Change notification 27.01.2026 Other Gabapentin Holsten 100 mg hard capsules Moxifloxacin hydrochloride (Ph.Eur.) ((with information on water content (1:x))) Change notification 27.01.2026 Other Moxifloxacin Holsten 400 mg film-coated tablets Atomoxetine hydrochloride Change notification 27.01.2026 Production problem Atomoxetine-neuraxpharm 100 mg hard capsules Atomoxetine hydrochloride Change notification 27.01.2026 Production problem Atomoxetine-neuraxpharm 80 mg hard capsules Atomoxetine hydrochloride Change notification 27.01.2026 Production problem Atomoxetine-neuraxpharm 40 mg hard capsules Atomoxetine hydrochloride Change notification 27.01.2026 Production problem Atomoxetine-neuraxpharm 25 mg hard capsules Atomoxetine hydrochloride Change notification 27.01.2026 Production problem Atomoxetine-neuraxpharm 18 mg hard capsules Atomoxetine hydrochloride Change notification 27.01.2026 Production problem Atomoxetine-neuraxpharm 10 mg hard capsules Atomoxetine hydrochloride Change notification 27.01.2026 Production problem Atomoxetine-neuraxpharm 60 mg hard capsules Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 26.01.2026 Other Atorvastatin Micro Labs 60 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 26.01.2026 Other Atorvastatin Micro Labs 30 mg film-coated tablets Fluoxetine hydrochloride Change notification 26.01.2026 Other Fluoxetine Micro Labs 60 mg hard capsules Fluoxetine hydrochloride Change notification 26.01.2026 Other Fluoxetine Micro Labs 30 mg hard capsules Naloxone hydrochloride dihydrate; oxycodone hydrochloride (Ph.Eur.) Change notification 26.01.2026 Production problem Targin 40 mg/20 mg prolonged-release tablets Zonisamide Change notification 26.01.2026 Production problem Zonisamide Glenmark 100 mg hard capsules Levofloxacin hemihydrate Change notification 26.01.2026 Production problem Levofloxacin Kabi 5 mg/ml solution for infusion Ciprofloxacin sulfate (1:1) Change notification 26.01.2026 Production problem Ciprofloxacin Kabi 200 mg/100 ml solution for infusion Rizatriptan benzoate Change notification 26.01.2026 Production problem Rizatriptan Glenmark 5 mg tablets Rizatriptan benzoate Change notification 26.01.2026 Production problem Rizatriptan Glenmark 5 mg orodispersible tablets Quetiapine fumarate (Ph.Eur.) Initial report 26.01.2026 Production problem Quetiapine Glenmark 50 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 26.01.2026 Production problem Quetiapine Glenmark 150 mg prolonged-release tablets - 2026.01.26
Active ingredients Message type Date of last message Type of reason AM designation Quetiapine fumarate (Ph.Eur.) Change notification 23.01.2026 Production problem Quetiapine Glenmark 200 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 23.01.2026 Production problem Quetiapine Glenmark 400 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 23.01.2026 Production problem Quetiapine Glenmark 150 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 23.01.2026 Production problem Quetiapine Glenmark 300 mg prolonged-release tablets Rifampicin sodium Change notification 23.01.2026 Other Eremfat i.v. 300mg Ivermectin Change notification 23.01.2026 Other DRIPONIN 3 mg tablets Galantamine hydrobromide Change notification 23.01.2026 Production problem Galantamine Glenmark 8 mg hard capsules, delayed release Galantamine hydrobromide Change notification 23.01.2026 Production problem Galantamine Glenmark 24 mg hard capsules, delayed release Galantamine hydrobromide Change notification 23.01.2026 Production problem Galantamine Glenmark 16 mg hard capsules, delayed release Fibrinogen, human Change notification 23.01.2026 Other Fibryga Isoniazid Initial report 23.01.2026 Other Isozid 50 mg Mannitol (Ph.Eur.) Change notification 23.01.2026 Other Bronchitol 40 mg hard capsule with powder for inhalation – OP10(1×10) Dexketoprofen trometamol Change notification 23.01.2026 Production problem Sympal inject 50 mg solution for injection/infusion Valaciclovir hydrochloride Initial report 22.01.2026 Other Valaciclovir – 1A Pharma 500 mg film-coated tablets Valaciclovir hydrochloride Initial report 22.01.2026 Other Valaciclovir – 1A Pharma 1000 mg film-coated tablets Fluoxetine hydrochloride Change notification 22.01.2026 Other Fluoxetine Micro Labs 30 mg hard capsules Clomipramine hydrochloride Change notification 22.01.2026 Production problem Anafranil 75 mg retard Ropivacaine hydrochloride monohydrate Initial report 21.01.2026 Production problem NAROPIN 10mg/ml Amp.10ml Solution for injection Ropivacaine hydrochloride monohydrate Initial report 21.01.2026 Other NAROPIN 2 mg/ml Amp. 20 ml Solution for injection Quetiapine fumarate (Ph.Eur.) Change notification 21.01.2026 Other Seroquel Prolong 200 mg prolonged-release tablets Epirubicin hydrochloride Change notification 21.01.2026 Production problem Epirubicin Hikma 2 mg/ml concentrate for solution for infusion Vancomycin hydrochloride Change notification 21.01.2026 Other Vancomycin CP 500mg Lidocaine hydrochloride monohydrate Change notification 21.01.2026 Other Xylocaine Gel 2% Cyclophosphamide monohydrate Initial report 21.01.2026 Production problem Endoxan 200 mg Cyclophosphamide monohydrate Initial report 21.01.2026 Production problem Endoxan 500 mg Cyclophosphamide monohydrate Initial report 21.01.2026 Production problem Endoxan 1 g Ifosfamide Initial report 21.01.2026 Production problem Holoxan Phenobarbital sodium Change notification 20.01.2026 Other Luminal injection solution Salbutamol sulfate Initial report 20.01.2026 Other Bronchospray Autohaler Lorazepam Change notification 20.01.2026 Other Tavor 2.5 mg Expidet Epinephrine/Adrenaline Change notification 20.01.2026 Production problem Anapen 500 micrograms solution for injection Insulin glargine Change notification 20.01.2026 Other Semglee Insulin glargine Change notification 20.01.2026 Other Semglee 100 units/ml solution for injection in pre-filled pen – OP (5x3ml) Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y) Change notification 20.01.2026 Other Ferrlecit 40 mg Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y) Change notification 20.01.2026 Other Ferrlecit 62.5 mg Tamsulosin hydrochloride Change notification 20.01.2026 Other Tamsulosin hydrochloride PUREN 0.4 mg prolonged-release capsules Pregabalin Change notification 20.01.2026 Other Pregabalin Aurobindo 25 mg hard capsules Buprenorphine hydrochloride Change notification 20.01.2026 Other Buprenorphine PUREN 8 mg sublingual tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 20.01.2026 Other Atorvastatin PUREN 40 mg film-coated tablets Rosuvastatin calcium (Ph.Eur.) Change notification 20.01.2026 Other Rosuvastatin Aurobindo 20 mg film-coated tablets Anastrozole Change notification 20.01.2026 Other Anastrozole Denk 1 mg film-coated tablets Propranolol hydrochloride Initial report 19.01.2026 Other DOCITON 10mg Nitrendipine Initial report 19.01.2026 Other Nitrendipine Aristo 10 mg film-coated tablets Arsenic(III) oxide Change notification 19.01.2026 Other TRISENOX 2 mg/ml concentrate for solution for infusion Dinoprost Initial report 19.01.2026 Other Propess 10 mg vaginal delivery system Adalimumab Change notification 19.01.2026 Other Amsparity Adalimumab Change notification 19.01.2026 Other Amsparity Methanthelinium bromide Initial report 19.01.2026 Production problem Vagantin RIEMSER Betamethasone dipropionate (Ph.Eur.); salicylic acid Initial report 19.01.2026 Other Soderm plus solution 0.64 mg/g + 20 mg/g solution for application to the skin - 2026.01.19
Active ingredients Message type Date of last message Type of reason AM designation Metformin hydrochloride Change notification 16.01.2026 Other Metformin 500 – 1 A Pharma Pramipexole dihydrochloride monohydrate Change notification 16.01.2026 Other Pramipexole – 1 A Pharma 0.26 mg prolonged-release tablets Alprazolam Change notification 16.01.2026 Other Alprazolam – 1 A Pharma 0.5 mg tablets Tetrabenazine Change notification 16.01.2026 Other Tetrabenazine Aristo 25 mg tablets Tamoxifen citrate Change notification 16.01.2026 Production problem Tamoxifen Aristo 10 mg tablets Nitrendipine Change notification 16.01.2026 Production problem Nitrendipine Aristo 20 mg film-coated tablets Von Willebrand factor Change notification 16.01.2026 Other WILLFACT 1000 I.U. Calcium acetate; heavy, basic magnesium carbonate Change notification 16.01.2026 Production problem OsvaRen Methyldopa (Ph.Eur.) Initial report 16.01.2026 Other Dopegyt tablets Rifampicin sodium Change notification 16.01.2026 Other Eremfat i.v. 600mg Lorazepam Change notification 15.01.2026 Other Tavor 2.5 mg Expidet Insulin aspart Initial report 15.01.2026 Production problem Fiasp 100 units/ml solution for injection in pre-filled pen – OP10[2x(5x3ml)] Clonidine hydrochloride Change notification 15.01.2026 Other Clonidine-ratiopharm 75 Clonidine hydrochloride Change notification 15.01.2026 Other Clonidine-ratiopharm 150 Clonidine hydrochloride Change notification 15.01.2026 Other Clonidine-ratiopharm 300 Sufentanil citrate Change notification 15.01.2026 Production problem Sufenta mite Naloxone hydrochloride dihydrate; oxycodone hydrochloride (Ph.Eur.) Initial report 15.01.2026 Production problem Targin 40 mg/20 mg prolonged-release tablets Primidone Change notification 15.01.2026 Production problem Mylepsinum Buprenorphine Change notification 15.01.2026 Other Buprenorphine AWD Matrix 70 micrograms/h Transdermal patch Buprenorphine Change notification 15.01.2026 Other Buprenorphine AWD Matrix 52.5 micrograms/h Transdermal patch Colistimethate sodium Change notification 15.01.2026 Production problem Colistin CF Ipratropium bromide (Ph.Eur.) Change notification 15.01.2026 Production problem Ipratropium Teva 250 micrograms/1 ml solution for nebulizer Nitrendipine Change notification 15.01.2026 Other Nitrendipine AbZ 20 mg tablets Nitrendipine Change notification 15.01.2026 Other Nitrendipine-ratiopharm 10 mg tablets Buprenorphine Change notification 15.01.2026 Other Buprenorphine-ratiopharm 35 micrograms/h transdermal patch Buprenorphine Change notification 15.01.2026 Other Buprenorphine-ratiopharm 52.5 micrograms/h transdermal patch Buprenorphine Change notification 15.01.2026 Other Buprenorphine-ratiopharm 70 micrograms/h transdermal patch Everolimus Change notification 15.01.2026 Other Everolimus-ratiopharm 10 mg tablets Everolimus Change notification 15.01.2026 Other Everolimus-ratiopharm 2.5 mg tablets Everolimus Change notification 15.01.2026 Other Everolimus-ratiopharm 5 mg tablets Fibrinogen, human Change notification 15.01.2026 Other Fibryga Alprazolam Change notification 15.01.2026 Other Alprazolam-ratiopharm 1.0 mg tablets Nitrendipine Change notification 15.01.2026 Other Nitrendipine-ratiopharm 20 mg tablets Methylphenidate hydrochloride Change notification 14.01.2026 Other METHYLPHENIDATE 20 mg tablets Sumatriptan succinate Initial report 14.01.2026 Production problem MIGRAPEN 3 mg/0.5 ml solution for injection in a pre-filled pen Ipratropium bromide (Ph.Eur.); salbutamol sulfate Change notification 14.01.2026 Production problem COMBIPRASAL 0.5 mg / 2.5 mg solution for nebulizer Tropicamide Change notification 14.01.2026 Production problem Mydriaticum Stulln UD Ethambutol dihydrochloride Initial report 14.01.2026 Production problem EMB-FATOL 400 mg Dinoprostone Change notification 14.01.2026 Production problem Minprostin E2 vaginal tablets Dinoprostone Change notification 14.01.2026 Other Minprostin E2 vaginal gel 1mg Dinoprostone Change notification 14.01.2026 Other Minprostin E2 vaginal gel 2 mg Tacrolimus monohydrate Change notification 14.01.2026 Other Tacrolimus AL 5 mg hard capsules, delayed release Tacrolimus monohydrate Change notification 14.01.2026 Other Tacrolimus AL 1 mg hard capsules, delayed release Tacrolimus monohydrate Change notification 14.01.2026 Other Tacrolimus AL 0.5 mg hard capsules, delayed release Tacrolimus monohydrate Change notification 14.01.2026 Other Tacrolimus AL 3 mg hard capsules, delayed release Rifampicin Initial report 14.01.2026 Production problem Eremfat syrup Rifampicin Initial report 14.01.2026 Production problem EREMFAT 450 mg Alprazolam Change notification 14.01.2026 Other Alprazolam AbZ 0.5 mg tablets Methylphenidate hydrochloride Change notification 14.01.2026 Other Methylphenidate hydrochloride-neuraxpharm 27 mg prolonged-release tablets (2-aminoethyl)dihydrogen phosphate calcium salt (1:1) Change notification 14.01.2026 Other Calcium EAP Sodium (methylprednisolone-21-succinate) Change notification 13.01.2026 Other Urbason solubile forte 250 mg Sodium (methylprednisolone-21-succinate) Change notification 13.01.2026 Other Urbason soluble forte 1000 mg Rizatriptan benzoate Change notification 13.01.2026 Other Rizatriptan PUREN 10 mg tablets Levetiracetam Initial report 13.01.2026 Production problem Levetiracetam Holsten 750 mg film-coated tablets Levetiracetam Initial report 13.01.2026 Production problem Levetiracetam Holsten 500 mg film-coated tablets Levetiracetam Change notification 13.01.2026 Production problem Levetiracetam Holsten 250 mg film-coated tablets Fluphenazine decanoate Change notification 13.01.2026 Production problem Fluphenazine-neuraxpharm D 100 mg/ml Fluphenazine decanoate Change notification 13.01.2026 Production problem Fluphenazine-neuraxpharm D 25 mg/ml Fluphenazine decanoate Change notification 13.01.2026 Production problem Fluphenazine-neuraxpharm D 12.5 mg/0.5 ml Fluphenazine decanoate Change notification 13.01.2026 Production problem Fluphenazine-neuraxpharm D 50 mg/0.5 ml Clonidine hydrochloride Initial report 13.01.2026 Production problem Clonistada 0.3 mg tablets Erythromycin Initial report 13.01.2026 Other Inderm Aprepitant Change notification 13.01.2026 Other Aprepitant AL 125 mg and 80 mg hard capsules Aprepitant Change notification 13.01.2026 Other Aprepitant AL 125 mg hard capsules Aprepitant Change notification 13.01.2026 Other Aprepitant AL 80 mg hard capsules Quetiapine fumarate (Ph.Eur.) Change notification 13.01.2026 Other Quetiapine AL 50 mg prolonged-release tablets Propranolol hydrochloride Initial report 13.01.2026 Other DOCITON 80mg Fluoxetine hydrochloride Change notification 13.01.2026 Other Fluoxetine Micro Labs 60 mg hard capsules Fluoxetine hydrochloride Change notification 13.01.2026 Other Fluoxetine Micro Labs 30 mg hard capsules Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 13.01.2026 Other Atorvastatin Micro Labs 30 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 13.01.2026 Other Atorvastatin Micro Labs 60 mg film-coated tablets Citalopram hydrobromide Change notification 13.01.2026 Production problem Citalopram STADA 10 mg film-coated tablets Ciprofloxacin sulfate (1:1) Initial report 12.01.2026 Production problem Ciprofloxacin Kabi 200 mg/100 ml solution for infusion Galantamine hydrobromide Change notification 12.01.2026 Other Galanaxiro 8 mg hard capsules, delayed release Galantamine hydrobromide Change notification 12.01.2026 Other Galanaxiro 16 mg hard capsules, delayed release Galantamine hydrobromide Change notification 12.01.2026 Other Galanaxiro 24 mg hard capsules, delayed release - 2026.01.12
Active ingredients Message type Date of last message Type of reason AM designation Human fibrinogen Change notification 11.01.2026 Other FibCLOT Trimipramine mesylate Change notification 09.01.2026 Other Trimipramine – 1 A Pharma 40 mg/ml oral drops, solution Etoposide phosphate Initial report 09.01.2026 Production problem Etopophos 1000 mg, powder for solution for infusion Vandetanib Initial report 09.01.2026 Other Caprelsa 300 mg film-coated tablets – OP30 Phenobarbital sodium Initial report 09.01.2026 Other Luminal solution for injection Levetiracetam Initial report 09.01.2026 Other Keppra 100 mg/ml oral solution – OP (1x150ml) Morphine hemisulfate 2.5 hydrate Initial report 09.01.2026 Production problem Substitol 60 mg hard capsule, delayed release Erythromycin lactobionate Initial report 09.01.2026 Production problem Erythromycin Inresa i.v. 1g Lidocaine hydrochloride monohydrate Change notification 09.01.2026 Other Xylocaine Gel 2% Mometasone furoate (Ph.Eur.) Initial report 09.01.2026 Production problem Momecutan solution Insulin aspart Initial report 09.01.2026 Other NovoRapid 100 E/ml solution for injection in vial – OP[5x(1x10ml)] Pramipexole dihydrochloride monohydrate Change notification 09.01.2026 Other Pramipexole – 1 A Pharma 0.26 mg prolonged-release tablets Aprepitant Change notification 09.01.2026 Other EMEND 125 mg powder for oral suspension – OPXXXXmg Oxytocin Change notification 09.01.2026 Production problem Oxytocin 3 IU Hexal Metamizole sodium monohydrate Change notification 09.01.2026 Production problem Novaminsulfon – 1 A Pharma Drops Digoxin Change notification 08.01.2026 Production problem Lanicor Methylprednisolone Change notification 08.01.2026 Production problem Urbason 16 mg tablets (RS)-2,3-Bis(sulfanyl)propane-1-sulfonic acid sodium salt monohydrate Initial report 08.01.2026 Production problem Dimaval Epoetin theta Initial report 08.01.2026 Other Eporatio 5000 IU/0.5 ml injection solution in pre-filled syringe – OP (6×0.5 ml) Insulin aspart Change notification 08.01.2026 Other Kirsty 100 units/ml solution for injection in a pre-filled pen Insulin aspart Change notification 08.01.2026 Other Kirsty 100 units/ml solution for injection in a pre-filled pen Doxycycline monohydrate Initial report 08.01.2026 Other Doxycycline AL 200 Dinoprostone Initial report 08.01.2026 Other Prepidil Gel Fusidic acid (Ph.Eur.) Change notification 08.01.2026 Production problem Fucithalmic 10 mg/g eye drops Indomethacin Initial report 08.01.2026 Other Indomethacin AL 50 Oxycodone hydrochloride (Ph.Eur.) Change notification 08.01.2026 Production problem Oxygesic injection 10 mg/ml Lanreotide acetate (1:x) ((with information on acetic acid content)) Change notification 08.01.2026 Production problem Mytolac 120 mg solution for injection in a pre-filled syringe Lanreotide acetate (1:x) ((with information on acetic acid content)) Change notification 08.01.2026 Production problem Mytolac 90 mg solution for injection in a pre-filled syringe Risperidone Change notification 08.01.2026 Production problem Risperidone-ratiopharm 25 mg powder and solvent for the preparation of a prolonged-release injection suspension Risperidone Change notification 08.01.2026 Production problem Risperidone-ratiopharm 37.5 mg powder and solvent for the preparation of a prolonged-release injection suspension Risperidone Change notification 08.01.2026 Production problem Risperidone-ratiopharm 50 mg powder and solvent for the preparation of a depot injection suspension Sodium (methylprednisolone-21-succinate) Change notification 07.01.2026 Other Urbason solubile forte 1000 mg Paliperidone palmitate Initial report 07.01.2026 Production problem Paliperidone Advanz Pharma 150 mg depot injection suspension in a pre-filled syringe Paliperidone palmitate Initial report 07.01.2026 Production problem Paliperidone Advanz Pharma 100 mg Depot injection suspension in a pre-filled syringe Paliperidone palmitate Change notification 07.01.2026 Production problem Paliperidone Advanz Pharma 25 mg prolonged-release suspension for injection in a pre-filled syringe Paliperidone palmitate Change notification 07.01.2026 Production problem Paliperidone Advanz Pharma 50 mg prolonged-release suspension for injection in a pre-filled syringe Paliperidone palmitate Change notification 07.01.2026 Production problem Paliperidone Advanz Pharma 75 mg depot injection suspension in a pre-filled syringe Albendazole Initial report 07.01.2026 Other Eskazole Lamotrigine Initial report 07.01.2026 Other Lamictal 5 mg tablets for the preparation of an oral suspension or chewable tablets Disodium pamidronate Initial report 07.01.2026 Production problem PAMIDRO-cell 3 mg/ml concentrate for solution for infusion Biperiden hydrochloride Change notification 07.01.2026 Production problem Biperiden-neuraxpharm 4 mg Biperiden hydrochloride Change notification 07.01.2026 Production problem Biperiden-neuraxpharm 2 mg Galantamine hydrobromide Change notification 07.01.2026 Other Galantamine-neuraxpharm 8 mg hard capsules, delayed release Galantamine hydrobromide Change notification 07.01.2026 Other Galantamine-neuraxpharm 16 mg Hard capsules, delayed release Galantamine hydrobromide Change notification 07.01.2026 Other Galantamine-neuraxpharm 24 mg hard capsules, delayed release Cisatracurium besylate Change notification 07.01.2026 Other Nimbex 5mg Doxorubicin hydrochloride Change notification 07.01.2026 Production problem Doxorubicin hydrochloride Bendalis 2 mg/ml Fluorouracil Change notification 07.01.2026 Other Benda-5 FU Somatostatin acetate Change notification 07.01.2026 Production problem Somatostatin 3 mg Inresa Deferasirox Change notification 06.01.2026 Other Deferasirox Mylan 180 mg film-coated tablets Tenofovir disoproxil Change notification 06.01.2026 Other Tenofovir disoproxil Viatris 245 mg film-coated tablets – OP30 Tenofovir disoproxil Change notification 06.01.2026 Other Tenofovir disoproxil Mylan 245 mg film-coated tablets – OP90(3×30) Hydrochlorothiazide; Valsartan Change notification 06.01.2026 Other VALSARTAN COMP BASICS 160 mg/25 mg film-coated tablets Hydrochlorothiazide; Valsartan Change notification 06.01.2026 Other VALSARTAN COMP BASICS 80 mg/12.5 mg film-coated tablets Hydrochlorothiazide; Valsartan Change notification 06.01.2026 Other VALSARTAN COMP BASICS 160 mg/12.5 mg film-coated tablets Beclomethasone dipropionate (Ph.Eur.); formoterol fumarate dihydrate (Ph.Eur.); glycopyrronium bromide (Ph.Eur.) Initial report 06.01.2026 Production problem Trimbow 87 micrograms/5 micrograms/9 micrograms pressurized gas inhalation, solution – OP360 cans (3×120 cans) Aprepitant Change notification 05.01.2026 Production problem Aprepitant beta 125 mg and 80 mg hard capsules Atomoxetine hydrochloride Change notification 05.01.2026 Production problem Atomoxetine beta 80 mg hard capsules Aprepitant Change notification 05.01.2026 Production problem Aprepitant beta 80 mg hard capsules Fluoxetine hydrochloride Change notification 05.01.2026 Other Fluoxetine beta 20 Penicillamine Change notification 05.01.2026 Production problem Metalcaptase 150 mg Iron(III) hexacyanoferrate(II) Change notification 05.01.2026 Other Thallium antidote Rivastigmine hydrogen tartrate Change notification 05.01.2026 Production problem Rivastigmine Aurobindo 6 mg hard capsules Insulin lispro Initial report 05.01.2026 Other Liprolog 200 units/ml solution for injection in pre-filled pen – OP[2x(5x3ml)] Hydromorphone hydrochloride Change notification 05.01.2026 Other Hydromorphone HCl PUREN 4 mg hard capsules, delayed release Escitalopram oxalate Change notification 05.01.2026 Other Escitalopram Aurobindo 10 mg film-coated tablets Flucloxacillin sodium 1 H<2>O Change notification 05.01.2026 Production problem Staphylex 250 mg capsules Moxifloxacin hydrochloride (Ph.Eur.) ((with information on water content (1:x))) Change notification 05.01.2026 Other Moxifloxacin Holsten 400 mg film-coated tablets Insulin lispro Initial report 05.01.2026 Other Liprolog 100 E/ml KwikPen solution for injection – OP[2x(5x3ml)] Clomipramine hydrochloride Change notification 05.01.2026 Production problem Anafranil 75mg retard Quetiapine fumarate (Ph.Eur.) Change notification 05.01.2026 Other Seroquel Prolong 150 mg prolonged-release tablets Amlodipine besylate; Perindopril tert-butylamine Change notification 05.01.2026 Production problem Perindopril/amlodipine Denk 8 mg/5 mg tablets Gentamicin sulfate Change notification 05.01.2026 Production problem Gentamicin-POS Phenylephrine hydrochloride Change notification 05.01.2026 Production problem Neosynephrine-POS 5% Minocycline hydrochloride dihydrate (Ph.Eur.) Change notification 05.01.2026 Production problem Skid 50 mg Minocycline hydrochloride dihydrate (Ph.Eur.) Change notification 05.01.2026 Production problem Skid 100 mg Quetiapine fumarate (Ph.Eur.) Change notification 05.01.2026 Other Quetiapine Hormosan 300 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 05.01.2026 Other Quetiapine Hormosan 400 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 05.01.2026 Other Quetiapine-Hormosan 200 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 05.01.2026 Other Quetiapine-Hormosan 150 mg prolonged-release tablets Oxycodone hydrochloride (Ph.Eur.) Change notification 05.01.2026 Other Oxycan uno 10 mg prolonged-release tablets