- 2025.12.22
Active ingredients Message type Date of last message Type of reason AM designation Aprepitant Change notification 19.12.2025 Other EMEND 125 mg powder for oral suspension – OPXXXXmg Erythromycin Initial report 19.12.2025 Production problem Aknemycin solution Fibrinogen, human Change notification 19.12.2025 Production problem Haemocomplettan P 1g Fibrinogen, human Change notification 19.12.2025 Production problem Haemocomplettan P 2g Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y) Change notification 19.12.2025 Other Ferrlecit 62.5 mg Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y) Change notification 19.12.2025 Other Ferrlecit 40 mg Posaconazole Change notification 19.12.2025 Production problem Noxafil Esomeprazole hemimagnesium Change notification 19.12.2025 Production problem ESOMEPRAZOLE BASICS 40 mg gastro-resistant hard capsules Candesartan cilexetil Change notification 19.12.2025 Other CANDESARTAN BASICS 32 mg tablets Candesartan cilexetil Change notification 19.12.2025 Other CANDESARTAN BASICS 16 mg tablets Candesartan cilexetil Change notification 19.12.2025 Other CANDESARTAN BASICS 8 mg tablets Candesartan cilexetil Change notification 19.12.2025 Other CANDESARTAN BASICS 4 mg tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 19.12.2025 Other ATORVASTATIN BASICS 80 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 19.12.2025 Other ATORVASTATIN BASICS 30 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 19.12.2025 Other ATORVASTATIN BASICS 20 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 19.12.2025 Other ATORVASTATIN BASICS 10 mg film-coated tablets Ciprofloxacin hydrochloride monohydrate Change notification 19.12.2025 Other CIPRO BASICS 750 mg film-coated tablets Ciprofloxacin hydrochloride monohydrate Change notification 19.12.2025 Other CIPRO BASICS 250 mg film-coated tablets Ezetimibe; simvastatin Change notification 19.12.2025 Production problem EZETIMIB/SIMVA BASICS 10 mg/80 mg tablets Ezetimibe; simvastatin Change notification 19.12.2025 Production problem EZETIMIB/SIMVA BASICS 10 mg/40 mg tablets Ezetimibe; simvastatin Change notification 19.12.2025 Production problem EZETIMIB/SIMVA BASICS 10 mg/20 mg tablets Ezetimibe; simvastatin Change notification 19.12.2025 Production problem EZETIMIBE/SIMVA BASICS 10 mg/10 mg tablets Esomeprazole hemimagnesium Change notification 19.12.2025 Production problem ESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsules Betamethasone acetate (Ph.Eur.); Betamethasone dihydrogen phosphate disodium (Ph.Eur.) Initial report 19.12.2025 Other Celestan Depot Mesalazine Change notification 19.12.2025 Other Claversal 500 mg tablets Terazosin hydrochloride dihydrate Change notification 19.12.2025 Other Heitrin 2 mg Proxymetacaine hydrochloride Change notification 19.12.2025 Production problem Proparacaine-POS 0.5% Gentamicin sulfate Change notification 19.12.2025 Production problem Gentamicin POS Phenylephrine hydrochloride Change notification 19.12.2025 Production problem Neosynephrine-POS 10% Epoetin theta Initial report 18.12.2025 Production problem Eporatio 4000 IU/0.5 ml injection solution in pre-filled syringe – OP (6×0.5 ml) Etanercept Initial report 18.12.2025 Other Nepexto 50 mg solution for injection in a pre-filled syringe Etanercept Initial report 18.12.2025 Other Nepexto 50 mg solution for injection in a pre-filled syringe Etanercept Initial report 18.12.2025 Other Nepexto 50 mg solution for injection in a pre-filled pen Etanercept Initial report 18.12.2025 Other Nepexto 50 mg solution for injection in a pre-filled pen Rifampicin sodium Change notification 18.12.2025 Other Eremfat i.v. 600mg Urapidil Change notification 18.12.2025 Production problem Urapidil Bluefish 90 mg hard capsules, delayed release Urapidil Change notification 18.12.2025 Production problem Urapidil Bluefish 30 mg hard capsules, delayed release Hydromorphone hydrochloride Change notification 18.12.2025 Other Hydromorphone PAINBREAK 8 mg prolonged-release tablets Hydromorphone hydrochloride Change notification 18.12.2025 Other Hydromorphone PAINBREAK 4 mg prolonged-release tablets Hydromorphone hydrochloride Change notification 18.12.2025 Other Hydromorphone PAINBREAK 24 mg prolonged-release tablets Hydromorphone hydrochloride Change notification 18.12.2025 Other Hydromorphone PAINBREAK 16 mg prolonged-release tablets Dexamethasone dihydrogen phosphate disodium (Ph.Eur.) Initial report 18.12.2025 Other Dexafluid 1 mg/ml eye drops Ipratropium bromide (Ph.Eur.) Change notification 18.12.2025 Production problem Ipratropium Teva 250 micrograms/1 ml solution for nebulizer Quetiapine fumarate (Ph.Eur.) Change notification 18.12.2025 Other Quetiapine AbZ 150 mg prolonged-release tablets Nitrendipine Change notification 18.12.2025 Other Nitrendipine AbZ 10 mg tablets Quetiapine fumarate (Ph.Eur.) Change notification 18.12.2025 Other Quetiapine-ratiopharm 300 mg prolonged-release tablets Pramipexole dihydrochloride monohydrate Change notification 18.12.2025 Other Pramipexole-ratiopharm 0.52 mg prolonged-release tablets Propranolol hydrochloride Change notification 18.12.2025 Other Propra-ratiopharm 10 mg film-coated tablets Propranolol hydrochloride Change notification 18.12.2025 Other Propra-ratiopharm 40 mg film-coated tablets Propranolol hydrochloride Change notification 18.12.2025 Other Propra-ratiopharm 80 mg film-coated tablets Nitrendipine Change notification 18.12.2025 Other Nitrendipine-ratiopharm 20 mg tablets Galantamine hydrobromide Change notification 18.12.2025 Other Galantamine-ratiopharm 24 mg hard capsules, delayed release Galantamine hydrobromide Change notification 18.12.2025 Other Galantamine-ratiopharm 16 mg hard capsules, delayed release Galantamine hydrobromide Change notification 18.12.2025 Other Galantamine-ratiopharm 8 mg hard capsules, delayed release Doxepine hydrochloride (Ph.Eur.) Change notification 18.12.2025 Other Doxepin-ratiopharm 50 mg film-coated tablets Doxepine hydrochloride (Ph.Eur.) Change notification 18.12.2025 Other Doxepin-ratiopharm 25 mg film-coated tablets Dexamethasone dihydrogen phosphate disodium (Ph.Eur.) Change notification 18.12.2025 Other Dexa-ratiopharm 4 mg solution for injection Clonidine hydrochloride Change notification 18.12.2025 Other Clonidine-ratiopharm 300 Clonidine hydrochloride Change notification 18.12.2025 Other Clonidine-ratiopharm 150 Clonidine hydrochloride Change notification 18.12.2025 Other Clonidine-ratiopharm 75 Cinacalcet hydrochloride Change notification 18.12.2025 Other Cinacalcet-ratiopharm 30 mg film-coated tablets Alprazolam Change notification 18.12.2025 Other Alprazolam-ratiopharm 1.0 mg tablets Alprazolam Change notification 18.12.2025 Other Alprazolam-ratiopharm 0.5 mg tablets Nitrendipine Change notification 18.12.2025 Other Nitrendipine AL 10 Anastrozole Change notification 18.12.2025 Other Anastrozole Denk 1 mg film-coated tablets Folic acid hydrate (with information on water content (1:x)) Change notification 18.12.2025 Other Folic acid AL 5 mg tablets Erythromycin lactobionate Change notification 17.12.2025 Production problem Erythrocin-i.v. 1.0 g Methyldopa (Ph.Eur.) Change notification 17.12.2025 Production problem Methyldopa STADA 250 mg film-coated tablet Insulin aspart Change notification 17.12.2025 Other NovoRapid PumpCart 100 E/ml solution for injection in cartridge – OP[5x(5×1.6ml)] Paliperidone palmitate Change notification 17.12.2025 Other Paliperidone AL 50 mg Depot injection suspension in a pre-filled syringe Aprepitant Change notification 17.12.2025 Other Aprepitant AL 80 mg hard capsules Aprepitant Change notification 17.12.2025 Other Aprepitant AL 125 mg hard capsules Aprepitant Change notification 17.12.2025 Other Aprepitant AL 125 mg and 80 mg hard capsules Zoledronic acid monohydrate Change notification 17.12.2025 Other Zoledronic acid AL 4 mg/100 ml solution for infusion Potassium canrenoate Initial report 17.12.2025 Production problem Aldactone 10 ml Canrenoate Salbutamol sulfate Initial report 16.12.2025 Other Bronchospray novo Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 16.12.2025 Other Atorvastatin Micro Labs 10 mg film-coated tablets Levetiracetam Change notification 16.12.2025 Production problem Levetiracetam Holsten 250 mg film-coated tablets Moxifloxacin hydrochloride (Ph.Eur.) ((with information on water content (1:x))) Change notification 16.12.2025 Other Moxifloxacin Holsten 400 mg film-coated tablets Quetiapine fumarate (Ph.Eur.) Change notification 16.12.2025 Other Quetiapine AL 50 mg prolonged-release tablets Propofol Initial report 16.12.2025 Production problem Propofol-Lipuro 10 mg/ml Isosorbide mononitrate Change notification 16.12.2025 Other ISMN AL40 retard Isosorbide mononitrate Change notification 16.12.2025 Other ISMN AL 100 retard Primidone Initial report 16.12.2025 Other Primidone Holsten Amikacin sulfate Change notification 16.12.2025 Production problem Amikacin B. Braun 5 mg/ml infusion solution Amoxicillin trihydrate Change notification 16.12.2025 Other Amoxicillin AL TS Cefixime 3 H<2>O Change notification 16.12.2025 Other Cefixime AL 100 mg/5 ml powder for oral suspension Dexketoprofen trometamol Change notification 16.12.2025 Production problem Sympal inject 50 mg solution for injection/infusion Selegiline hydrochloride Change notification 16.12.2025 Other Selegiline AL 5 Clonidine hydrochloride Change notification 15.12.2025 Production problem Clonistada 0.15 mg tablets Lidocaine hydrochloride monohydrate Change notification 15.12.2025 Other Xylocaine Gel 2% Lidocaine Change notification 15.12.2025 Other XYLOCAIN PUMP SPRAY dental Calcium chloride dihydrate; histidine; histidine hydrochloride monohydrate; potassium hydrogen 2-oxopentanedioate; potassium chloride; magnesium chloride hexahydrate; mannitol (Ph.Eur.); sodium chloride; tryptophan Change notification 15.12.2025 Production problem Custodiol Rosuvastatin calcium (Ph.Eur.) Change notification 15.12.2025 Other Rosuvastatin Aurobindo 20 mg film-coated tablets Buprenorphine hydrochloride Change notification 15.12.2025 Other Buprenorphine PUREN 8 mg sublingual tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 15.12.2025 Other Atorvastatin PUREN 40 mg film-coated tablets Alprazolam Change notification 15.12.2025 Other Alprazolam – 1 A Pharma 0.5 mg tablets Oxytocin Change notification 15.12.2025 Production problem Oxytocin 3 I.E. Hexal Galantamine hydrobromide Change notification 15.12.2025 Other Galantamine – 1A Pharma 24 mg prolonged-release hard capsules Galantamine hydrobromide Change notification 15.12.2025 Other Galantamine – 1A Pharma 8 mg prolonged-release hard capsules Galantamine hydrobromide Change notification 15.12.2025 Other Galantamine – 1A Pharma 16 mg prolonged-release hard capsules Oxcarbazepine Change notification 15.12.2025 Other Oxcarbazepine – 1 A Pharma 60 mg/ml oral suspension Quetiapine fumarate (Ph.Eur.) Change notification 15.12.2025 Production problem Quetiapine HEXAL 300 mg prolonged-release tablets Indapamide; Perindopril arginine Initial report 15.12.2025 Other Perindopril arginine/indapamide Viatris 5 mg/1.25 mg film-coated tablets - 2025.12.15
Active ingredients Message type Date of last message Type of reason AM designation Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y) Change notification 12.12.2025 Other Ferrlecit 40 mg Clomipramine hydrochloride Initial report 12.12.2025 Other Clomipramine-neuraxpharm 75 mg retard Epoetin zeta Initial report 12.12.2025 Other Retacrit 40,000 IU/1 ml solution for injection in pre-filled syringe Epoetin zeta Initial report 12.12.2025 Other Retacrit 40,000 IU/1 ml solution for injection in pre-filled syringe Atorvastatin calcium trihydrate (Ph.Eur.) Initial report 11.12.2025 Other Atorvastatin Micro Labs 10 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 11.12.2025 Other Atorvastatin Micro Labs 30 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 11.12.2025 Other Atorvastatin Micro Labs 60 mg film-coated tablets Fluoxetine hydrochloride Change notification 11.12.2025 Other Fluoxetine Micro Labs 60 mg hard capsules Fluoxetine hydrochloride Change notification 11.12.2025 Other Fluoxetine Micro Labs 30 mg hard capsules Quetiapine fumarate (Ph.Eur.) Change notification 11.12.2025 Other Quetiapine AL 200 mg prolonged-release tablets Prednicarbate Change notification 11.12.2025 Other Prednicarbate acis solution Zoledronic acid monohydrate Initial report 11.12.2025 Other Zoledronic acid AL 4 mg/100 ml infusion solution Ibandronate sodium monohydrate Initial report 11.12.2025 Other Ibandronic acid AL 3 mg solution for injection in a pre-filled syringe Fibrinogen, human Initial report 10.12.2025 Other Fibryga Sodium (hydrocortisone-21-succinate) Change notification 10.12.2025 Production problem Hydrocortisone PANPHARMA 100 mg Methylphenidate hydrochloride Change notification 10.12.2025 Other CONCERTA 54 mg prolonged-release tablets Methylphenidate hydrochloride Change notification 10.12.2025 Other CONCERTA 36 mg prolonged-release tablets Methylphenidate hydrochloride Change notification 10.12.2025 Other CONCERTA 27 mg prolonged-release tablets Methylphenidate hydrochloride Change notification 10.12.2025 Other CONCERTA 18 mg prolonged-release tablets Dimenhydrinate Initial report 10.12.2025 Production problem Dimenhydrinate PANPHARMA 6.2 mg/ml solution for injection (i.v.) Metformin hydrochloride Initial report 10.12.2025 Other Metformin 500 – 1 A Pharma Candesartan cilexetil Initial report 10.12.2025 Other Blopress 16 mg Colistimethate sodium Initial report 10.12.2025 Production problem Colistin CF Risperidone Change notification 10.12.2025 Production problem Risperidone-ratiopharm 50 mg powder and solvent for the preparation of a depot injection suspension Risperidone Change notification 10.12.2025 Production problem Risperidone-ratiopharm 37.5 mg powder and solvent for the preparation of a depot injection suspension Risperidone Change notification 10.12.2025 Production problem Risperidone-ratiopharm 25 mg powder and solvent for the preparation of a depot injection suspension Ribavirin Change notification 10.12.2025 Production problem Ribavirin-ratiopharm 200 mg film-coated tablets Ribavirin Change notification 10.12.2025 Other Ribavirin-ratiopharm 400 mg film-coated tablets Levothyroxine sodium Initial report 10.12.2025 Other L-thyroxine-Na-ratiopharm 50 microgram tablets Levothyroxine sodium Initial report 10.12.2025 Other L-Thyroxine-Na-ratiopharm 25 microgram tablets Isoniazid; pyridoxine hydrochloride Initial report 09.12.2025 Other Isozid comp. 200 mg N Isoniazid Initial report 09.12.2025 Other Isozid 0.5 N Pyrazinamide Initial report 09.12.2025 Production problem Pyrafat 500mg Dapsone Initial report 09.12.2025 Production problem Dapson-Fatol Filgrastim Initial report 09.12.2025 Other Nivestim 12 million E/0.2 ml injection/infusion solution – OP (5×0.2 ml) Adalimumab Initial report 09.12.2025 Other Amsparity Adalimumab Initial report 09.12.2025 Other Amsparity Adalimumab Initial report 09.12.2025 Other Amsparity Adalimumab Initial report 09.12.2025 Other Amsparity Risedronate sodium 2.5 hydrate (Ph.Eur.) Initial report 09.12.2025 Other Risedronate Aurobindo once weekly 35 mg film-coated tablets Terazosin hydrochloride dihydrate Change notification 09.12.2025 Other Heitrin 1mg Terazosin hydrochloride dihydrate Change notification 09.12.2025 Other Heitrin 5mg Terazosin hydrochloride dihydrate Change notification 09.12.2025 Other Heitrin 2 mg Metamizole sodium monohydrate Initial report 08.12.2025 Production problem Novaminsulfon – 1 A Pharma Drops Methylphenidate hydrochloride Initial report 08.12.2025 Other Equasym Retard 40 mg hard capsules with modified release Atorvastatin calcium trihydrate (Ph.Eur.) Initial report 08.12.2025 Other Atorvastatin – 1A Pharma 40 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Initial report 08.12.2025 Other Atorvastatin – 1A Pharma 10 mg film-coated tablets Quetiapine fumarate (Ph.Eur.) Change notification 08.12.2025 Other Seroquel Prolong 50 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 08.12.2025 Other Seroquel Prolong 300 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 08.12.2025 Other Seroquel Prolong 200 mg prolonged-release tablets - 2025.12.08
供給不足データベースLieferengpass Datenbankenが一時的にダウンしているようです（12月8日）。
- 2025.12.01
Active ingredients Message type Date of last message Type of reason AM designation Moxifloxacin hydrochloride (Ph.Eur.) ((with information on water content (1:x))) Change notification 28.11.2025 Other Moxifloxacin Micro Labs 400 mg film-coated tablets Levothyroxine sodium Change notification 28.11.2025 Production problem L-thyroxine Henning 50 Levothyroxine sodium Change notification 28.11.2025 Production problem L-Thyroxine Aventis 150 microgram tablets Ivermectin Initial report 28.11.2025 Other DRIPONIN 3 mg tablets Escitalopram oxalate Initial report 28.11.2025 Production problem Escitalopram STADA 20 mg film-coated tablets Rifampicin sodium Change notification 28.11.2025 Other Eremfat i.v. 600mg Insulin glargine Change notification 28.11.2025 Other Semglee Insulin glargine Change notification 28.11.2025 Other Semglee 100 units/ml solution for injection in pre-filled pen – OP(5x3ml) Posaconazole Initial report 28.11.2025 Production problem Noxafil Olanzapine Initial report 27.11.2025 Production problem Zyprexa 2.5 mg coated tablets – OP70 (blister pack) Ibuprofen Initial report 27.11.2025 Production problem Ibuprofen Kabi 400 mg solution for infusion Adenosine Change notification 27.11.2025 Production problem Adenosine Altamedics 3 mg/ml solution for injection Adenosine Change notification 27.11.2025 Production problem Adenosine Altamedics 30 mg/10 ml solution for infusion Tacrolimus monohydrate Change notification 27.11.2025 Other Tacrolimus AL 3 mg hard capsules, delayed release Tacrolimus monohydrate Change notification 27.11.2025 Other Tacrolimus AL 0.5 mg hard capsules, delayed release Tacrolimus monohydrate Change notification 27.11.2025 Other Tacrolimus AL 1 mg hard capsules, delayed release Tacrolimus monohydrate Change notification 27.11.2025 Other Tacrolimus AL 5 mg hard capsules, delayed release Quetiapine fumarate (Ph.Eur.) Initial report 27.11.2025 Other Seroquel 25 mg film-coated tablets Quetiapine fumarate (Ph.Eur.) Change notification 27.11.2025 Other Seroquel Prolong 200 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 27.11.2025 Other Seroquel Prolong 300 mg prolonged-release tablets Tolterodine tartrate Change notification 27.11.2025 Other Detrusitol 2 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 27.11.2025 Other Atorvastatin Aristo 80 mg film-coated tablets Primidone Change notification 27.11.2025 Production problem Mylepsinum Doxepin hydrochloride (Ph.Eur.) Change notification 26.11.2025 Production problem Doxepin 25 Holsten Doxepin hydrochloride (Ph.Eur.) Change notification 26.11.2025 Production problem Doxepin 75 Holsten Amlodipine besylate; hydrochlorothiazide; valsartan Change notification 26.11.2025 Other Amlodipine/Valsartan/HCT Holsten 5 mg/160 mg/12.5 mg film-coated tablets Gabapentin Change notification 26.11.2025 Production problem Gabapentin Holsten 800 mg film-coated tablets Prednicarbat Initial report 26.11.2025 Production problem Prednicarbat acis solution Haloperidol decanoate Change notification 26.11.2025 Production problem Haloperidol-neuraxpharm decanoate 100 mg/ml Haloperidol decanoate Change notification 26.11.2025 Production problem Haloperidol-neuraxpharm decanoate 50 mg/ml Dexketoprofen trometamol Change notification 26.11.2025 Production problem Sympal inject 50 mg solution for injection/infusion Pramipexole dihydrochloride monohydrate Change notification 26.11.2025 Other Pramipexole Mylan 3.15 mg prolonged-release tablets Isosorbide mononitrate Change notification 26.11.2025 Production problem ISMN STADA 40 mg tablets Isosorbide mononitrate Change notification 26.11.2025 Production problem ISMN STADA 20 mg tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 25.11.2025 Other Atorvastatin PUREN 40 mg film-coated tablets Rivastigmine hydrogen tartrate Change notification 25.11.2025 Production problem Rivastigmine Aurobindo 6 mg hard capsules Prasugrel Change notification 25.11.2025 Production problem Prasugrel PUREN 5 mg film-coated tablets Nevirapine Change notification 25.11.2025 Other Nevirapine Aurobindo 400 mg prolonged-release tablets Flucloxacillin sodium 1 H<2>O Change notification 25.11.2025 Production problem Staphylex 250 mg capsules Moxifloxacin hydrochloride (Ph.Eur.) ((with information on water content (1:x))) Change notification 25.11.2025 Other Moxifloxacin Holsten 400 mg film-coated tablets Oxazepam Change notification 25.11.2025 Other Oxazepam AL 10 Methylphenidate hydrochloride Change notification 25.11.2025 Other Metiphenal 10 mg modified-release hard capsules Mannitol (Ph.Eur.) Initial report 25.11.2025 Other Bronchitol 40 mg hard capsule with powder for inhalation – OP10(1×10) Alprazolam Initial report 25.11.2025 Other Alprazolam – 1 A Pharma 0.5 mg tablets Gabapentin Change notification 25.11.2025 Other Gabapentin Holsten 100 mg hard capsules Oxycodone hydrochloride Change notification 24.11.2025 Other OXYGESIC 10 mg Olipudase alfa Initial report 24.11.2025 Production problem Xenpozyme Benzylpenicillin benzathine tetrahydrate (Ph.Eur.) ((with information on the dispersing or suspending agent)) Initial report 24.11.2025 Production problem Tardocillin 1200 Benperidol Initial report 24.11.2025 Production problem Glianimon 2 ml Mivacurium chloride Initial report 24.11.2025 Production problem Mivacron 20mg Pregabalin Change notification 24.11.2025 Other Pregabalin PUREN 100 mg hard capsules Quetiapine fumarate (Ph.Eur.) Change notification 24.11.2025 Production problem Quetiapine – 1 A Pharma 150 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 24.11.2025 Production problem Quetiapine HEXAL 150 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 24.11.2025 Production problem Quetiapine HEXAL 50 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 24.11.2025 Production problem Quetiapine HEXAL 400 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 24.11.2025 Production problem Quetiapine – 1 A Pharma 300 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 24.11.2025 Production problem Quetiapine – 1 A Pharma 400 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 24.11.2025 Production problem Quetiapine – 1 A Pharma 50 mg prolonged-release tablets Salbutamol sulfate Change notification 24.11.2025 Other Bronchospray novo Quetiapine fumarate (Ph.Eur.) Change notification 24.11.2025 Production problem Quetiapine – 1 A Pharma 600 mg prolonged-release tablets Cefaclor monohydrate Change notification 24.11.2025 Other Cefaclor 125 TS – 1 A Pharma Progesterone Change notification 24.11.2025 Production problem LUTINUS 100 mg vaginal tablets Tinzaparin sodium Initial report 24.11.2025 Production problem innohep 4,500 Anti-Xa I.E. Solution for injection Vancomycin hydrochloride Change notification 24.11.2025 Other Vancomycin “Lederle” 1000mg - 2025.11.24
Active ingredients Message type Date of last message Type of reason AM designation Levothyroxine sodium Initial report 21.11.2025 Production problem L-thyroxine Aventis 150 microgram tablets Levothyroxine sodium Change notification 21.11.2025 Production problem L-Thyroxine Henning 50 Sevelamer carbonate Change notification 21.11.2025 Other Renvela 0.8 g powder for oral suspension – OP(90×842.32mg) Rizatriptan benzoate Change notification 21.11.2025 Production problem Rizatriptan Glenmark 5 mg orodispersible tablets Moxifloxacin hydrochloride (Ph.Eur.) ((with information on water content (1:x))) Initial report 20.11.2025 Other Moxifloxacin Micro Labs 400 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 20.11.2025 Other Atorvastatin Micro Labs 60 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Initial report 20.11.2025 Other Atorvastatin Micro Labs 40 mg film-coated tablets Sunitinib Initial report 20.11.2025 Other Sunitinib AL 37.5 mg hard capsules Sunitinib Initial report 20.11.2025 Other Sunitinib AL 12.5 mg hard capsules Atorvastatin calcium trihydrate (Ph.Eur.) Initial report 20.11.2025 Other Atorvastatin Micro Labs 30 mg film-coated tablets Isoniazid Initial report 20.11.2025 Other Isozid 100 mg Diazepam Initial report 20.11.2025 Other Diazepam-ratiopharm 10 mg/2 ml solution for injection Rifampicin sodium Initial report 20.11.2025 Other Eremfat i.v. 300mg Alprazolam Initial report 20.11.2025 Other Alprazolam AbZ 0.5 mg tablets Alprazolam Initial report 20.11.2025 Other Alprazolam-ratiopharm 0.5 mg tablets Trandolapril; verapamil hydrochloride Change notification 20.11.2025 Other Tarka 180 mg/2 mg modified-release tablets Morphine hemisulfate 2.5 hydrate Initial report 19.11.2025 Production problem Substitol 30 mg hard capsules, delayed release Hydromorphone hydrochloride Change notification 19.11.2025 Production problem Palladon injection 2 mg Aprepitant Change notification 19.11.2025 Other Aprepitant AL 125 mg and 80 mg hard capsules Quetiapine fumarate (Ph.Eur.) Change notification 19.11.2025 Other Quetiapine AL 300 mg film-coated tablets Beclomethasone dipropionate (Ph.Eur.) Change notification 19.11.2025 Other Beclorhinol aquosum 50 micrograms Nitrendipine Change notification 19.11.2025 Other Nitrendipine AL 20 Vinflunine bis[(R,R)-tartrate] Change notification 18.11.2025 Production problem Javlor 25 mg/ml concentrate for solution for infusion – OP(1x2ml) Chlortalidone Change notification 18.11.2025 Other Chlortalidone HEXAL 12.5 mg tablets Calcium trisodium pentetate (with information on water content, if applicable) Change notification 18.11.2025 Other Technescan DTPA Medium-chain triglycerides; omega-3 acid triglycerides (with information on origin and/or composition); refined soybean oil (Ph.Eur.) Change notification 18.11.2025 Production problem Lipidem Emulsion for infusion Aprepitant Change notification 18.11.2025 Production problem Aprepitant STADA 125 mg and 80 mg hard capsules Aprepitant Change notification 18.11.2025 Production problem Aprepitant STADA 80 mg hard capsules Aprepitant Change notification 18.11.2025 Production problem Aprepitant STADA 125 mg hard capsules Misoprostol Change notification 17.11.2025 Other Angusta 25 microgram tablets Insulin glargine Initial report 17.11.2025 Other ABASAGLAR 100 IU/ml solution for injection in pre-filled pen – OP (5x3ml) Posaconazole Change notification 17.11.2025 Other Posaconazole HEXAL 40 mg/ml oral suspension Lidocaine hydrochloride monohydrate Change notification 17.11.2025 Other Xylocaine Gel 2% Vancomycin hydrochloride Change notification 17.11.2025 Other Vancomycin “Lederle” 1000mg - 2025.11.18
Active ingredients Message type Date of last message Type of reason AM designation Hydromorphone hydrochloride Initial report 14.11.2025 Production problem Palladon inject 2 mg Sevelamer carbonate Initial report 14.11.2025 Other Renvela 0.8 g powder for oral suspension – OP(90×842.32mg) Pirfenidone Change notification 14.11.2025 Production problem Pirfenidone Accord 801 mg film-coated tablets Dinoprostone Initial report 14.11.2025 Other Minprostin E2 vaginal gel 2 mg Dinoprostone Initial report 14.11.2025 Other Minprostin E2 vaginal gel 1 mg Sertraline hydrochloride Change notification 14.11.2025 Other Sertraline TAD 100 mg film-coated tablets Sertraline hydrochloride Change notification 14.11.2025 Other Sertraline TAD 50 mg film-coated tablets Methyldopa (Ph.Eur.) Change notification 14.11.2025 Other Dopegyt tablets Quetiapine fumarate (Ph.Eur.) Change notification 14.11.2025 Other Seroquel Prolong 150 mg prolonged-release tablets Trandolapril; verapamil hydrochloride Change notification 13.11.2025 Other Tarka 240 mg/4 mg modified-release tablets Posaconazole Change notification 13.11.2025 Other Posaconazole AL 40 mg/ml oral suspension Methylphenidate hydrochloride Change notification 13.11.2025 Other Metiphenal 10 mg modified-release hard capsules Quetiapine fumarate (Ph.Eur.) Change notification 13.11.2025 Other Quetiapine AL 150 mg prolonged-release tablets Proxymetacaine hydrochloride Initial report 12.11.2025 Production problem Proparacaine-POS 0.5% Quetiapine fumarate (Ph.Eur.) Change notification 12.11.2025 Other Seroquel Prolong 50 mg prolonged-release tablets Tamsulosin hydrochloride Initial report 12.11.2025 Other Tamsulosin hydrochloride PUREN 0.4 mg prolonged-release capsules Pregabalin Change notification 12.11.2025 Other Pregabalin Aurobindo 25 mg hard capsules Ibuprofen Initial report 12.11.2025 Production problem Ibuprofen PUREN 600 mg film-coated tablets Gabapentin Initial report 12.11.2025 Other Gabapentin Aurobindo 600 mg film-coated tablets Urapidil Initial report 12.11.2025 Other Urapidil PUREN 60 mg prolonged-release capsules Urapidil Initial report 12.11.2025 Other Urapidil PUREN 30 mg prolonged-release capsules Fentanyl Change notification 12.11.2025 Production problem Fentanyl PUREN 25 micrograms/h transdermal patch Lamotrigine Initial report 12.11.2025 Production problem Lamotrigine Aurobindo 5 mg tablets for oral suspension Rizatriptan benzoate Change notification 12.11.2025 Production problem Rizatriptan PUREN 5 mg tablets Sitagliptin hydrochloride monohydrate Initial report 12.11.2025 Other Sitagliptin PUREN 25 mg film-coated tablets Gemcitabine hydrochloride Initial report 12.11.2025 Other Gemcitabine Aurobindo 40 mg/ml concentrate for solution for infusion Mesalazine Change notification 12.11.2025 Production problem Claversal Micropellets 1.5 g Risperidone Initial report 12.11.2025 Other Risperidone PUREN 3 mg film-coated tablets Risperidone Initial report 12.11.2025 Other Risperidone PUREN 0.5 mg film-coated tablets Mesalazine Initial report 12.11.2025 Other Claversal 500 mg tablets Propranolol hydrochloride Initial report 12.11.2025 Other Propranolol PUREN 10 mg film-coated tablets Buprenorphine hydrochloride Initial report 12.11.2025 Other Buprenorphine PUREN 8 mg sublingual tablets Oxycodone hydrochloride (Ph.Eur.) Initial report 12.11.2025 Other Oxycodone hydrochloride Puren 10 mg prolonged-release tablets Levetiracetam Initial report 12.11.2025 Other Levetiracetam PUREN 1000 mg film-coated tablets Levetiracetam Initial report 12.11.2025 Other Levetiracetam Aurobindo 1000 mg film-coated tablets Lamotrigine Initial report 12.11.2025 Other Lamotrigine Aurobindo 25 mg tablets Efavirenz; emtricitabine; tenofovir disoproxil fumarate Initial report 12.11.2025 Other Efavirenz/emtricitabine/tenofovir disoproxil PUREN 600 mg/200 mg/245 mg film-coated tablets Linezolid Initial report 12.11.2025 Other Linezolid PUREN 600 mg film-coated tablets Risperidone Initial report 12.11.2025 Other Risperidone Aurobindo 1 mg film-coated tablets Olanzapine embonate monohydrate Initial report 11.11.2025 Production problem ZYPADHERA 405 mg powder and solvent for the preparation of a depot injection suspension – OP(931mg+3ml) Aprepitant Change notification 11.11.2025 Other Aprepitant AL 125 mg hard capsules Oxazepam Change notification 11.11.2025 Other Oxazepam AL 10 Ciprofloxacin hydrochloride (1:1) 1 H<2>O Change notification 11.11.2025 Other Ciprohexal 100 mg Ciprofloxacin hydrochloride (1:1) 1 H<2>O Change notification 11.11.2025 Other Cipro-1 A Pharma 100mg Terbutaline sulfate (Ph.Eur.) Change notification 11.11.2025 Production problem BRICANYL 0.5 mg Nimodipine Change notification 10.11.2025 Other Nimodipine Hexal 30mg Insulin lispro Initial report 10.11.2025 Other Liprolog 100 E/ml solution for injection in cartridge – OP[2x(5x3ml)] Human insulin (with manufacturing details) Initial report 10.11.2025 Other Huminsulin Normal KwikPen 100 IU/ml solution for injection Calcium trisodium pentetate (with information on water content, if applicable) Initial report 10.11.2025 Other Technescan DTPA Sevelamer Change notification 10.11.2025 Other Renagel 800 mg film-coated tablets – OP(1×180) Tenofovir disoproxil fumarate Initial report 10.11.2025 Other Tenofovir disoproxil PUREN 245 mg film-coated tablets Lidocaine Initial report 10.11.2025 Other XYLOCAIN PUMP SPRAY Vinflunine bis[(R,R)-tartrate] Initial report 10.11.2025 Production problem Javlor 25 mg/ml concentrate for solution for infusion – OP (1x2ml) Ipratropium bromide (Ph.Eur.); salbutamol sulfate Change notification 10.11.2025 Production problem Ipratropium/salbutamol Cipla 0.5 mg/2.5 mg solution for nebulizer Valsartan Initial report 10.11.2025 Production problem Valsartan STADA 80 mg film-coated tablets Valsartan Initial report 10.11.2025 Production problem Valsartan STADA 160 mg film-coated tablets Aprepitant Initial report 10.11.2025 Other EMEND 125 mg powder for oral suspension – OPXXXXmg Amikacin sulfate Change notification 10.11.2025 Production problem Amikacin B. Braun 2.5 mg/ml solution for infusion Amikacin sulfate Change notification 10.11.2025 Production problem Amikacin B. Braun 5 mg/ml solution for infusion Tolterodine tartrate Change notification 10.11.2025 Other Detrusitol 2 mg film-coated tablets Ipratropium bromide Change notification 10.11.2025 Production problem Ipratropium bromide 125 micrograms/1 ml Stulln Duloxetine hydrochloride Initial report 10.11.2025 Other Cymbalta 60 mg gastro-resistant hard capsules – OP28 - 2025.11.10
Active ingredients Message type Date of last message Type of reason AM designation Darifenacin hydrobromide Initial report 07.11.2025 Other Darifenacin Aristo 15 mg prolonged-release tablets Tolterodine tartrate Initial report 07.11.2025 Other Tolterodine Aristo 1 mg film-coated tablets Tolterodine tartrate Initial report 07.11.2025 Other Tolterodine-Aristo 2 mg film-coated tablets Posaconazole Change notification 07.11.2025 Other Posaconazole HEXAL 40 mg/ml oral suspension Tolterodine tartrate Initial report 07.11.2025 Other Detrusitol 1 mg film-coated tablets Beclomethasone dipropionate (Ph.Eur.) Change notification 07.11.2025 Other Beclorhinol aquosum 50 micrograms Paliperidone palmitate Change notification 06.11.2025 Other XEPLION 25 mg prolonged-release suspension for injection – OP1ml Rifampicin sodium Change notification 06.11.2025 Other Eremfat i.v. 600mg Nitrendipine Initial report 06.11.2025 Other Nitrendipine AL 10 Urapidil Initial report 06.11.2025 Other Urapidil AL 90 mg hard capsules, delayed release Urapidil Initial report 06.11.2025 Other Urapidil AL 30 mg hard capsules, delayed release Imiquimod Change notification 06.11.2025 Production problem Aldara 5% cream – OP24 Calcium folinate hydrate Change notification 06.11.2025 Production problem Calcium folinate onkovis 10 mg/ml solution for injection Quetiapine fumarate (Ph.Eur.) Change notification 06.11.2025 Other Quetiapine AL 100 mg film-coated tablets Salbutamol sulfate Initial report 05.11.2025 Other Bronchospray Autohaler Imiquimod Change notification 05.11.2025 Production problem Imikeraderm 50 mg/g cream Sodium mycophenolate Initial report 05.11.2025 Other Mycophenolic acid HEXAL 180 mg gastro-resistant tablets Sodium mycophenolate Change notification 05.11.2025 Other Mycophenolic acid HEXAL 360 mg gastro-resistant tablets Sitagliptin hydrochloride monohydrate Change notification 05.11.2025 Production problem Sitagliptin PUREN 50 mg film-coated tablets Nimodipine Change notification 05.11.2025 Other Nimodipine Hexal 30 mg Propranolol hydrochloride Initial report 05.11.2025 Other Propra-ratiopharm 40 mg film-coated tablets Propranolol hydrochloride Initial report 05.11.2025 Other Propra-ratiopharm 10 mg film-coated tablets Dexamethasone dihydrogen phosphate disodium (Ph.Eur.) Initial report 05.11.2025 Other Dexa-ratiopharm 4 mg solution for injection Ipratropium bromide (Ph.Eur.) Change notification 05.11.2025 Production problem Ipratropium Teva 250 micrograms/1 ml solution for nebulizer Buprenorphine Change notification 05.11.2025 Other Buprenorphine AWD Matrix 52.5 micrograms/h Transdermal patch Buprenorphine Change notification 05.11.2025 Other Buprenorphine AWD Matrix 70 micrograms/h Transdermal patch Methylphenidate hydrochloride Change notification 05.11.2025 Other Methylphenidate-ratiopharm 10 mg modified-release hard capsules Galantamine hydrobromide Change notification 05.11.2025 Other Galantamine-ratiopharm 8 mg hard capsules, delayed release Carbamazepine Change notification 05.11.2025 Other Carbamazepine-ratiopharm 200 mg prolonged-release tablets Buprenorphine Change notification 05.11.2025 Other Buprenorphine-ratiopharm 70 micrograms/h transdermal patch Buprenorphine Change notification 05.11.2025 Other Buprenorphine-ratiopharm 52.5 micrograms/h Transdermal patch Buprenorphine Change notification 05.11.2025 Other Buprenorphine-ratiopharm 35 micrograms/h transdermal patch Alprazolam Change notification 05.11.2025 Other Alprazolam-ratiopharm 1.0 mg tablets Methylphenidate hydrochloride Change notification 05.11.2025 Other Methylphenidate-ratiopharm 40 mg modified-release hard capsules Doxepine hydrochloride (Ph.Eur.) Change notification 04.11.2025 Production problem Doxepin 25 Holsten Doxepine hydrochloride (Ph.Eur.) Change notification 04.11.2025 Other Doxepin 50 Holsten Doxepine hydrochloride (Ph.Eur.) Change notification 04.11.2025 Production problem Doxepin 75 Holsten Gabapentin Change notification 04.11.2025 Other Gabapentin Holsten 300 mg hard capsules Gabapentin Change notification 04.11.2025 Production problem Gabapentin Holsten 600 mg film-coated tablets Gabapentin Change notification 04.11.2025 Other Gabapentin Holsten 800 mg film-coated tablets Mercaptopurine Change notification 04.11.2025 Other Mercaptopurine Holsten 50 mg tablets Levetiracetam Change notification 04.11.2025 Other Levetiracetam Holsten 250 mg film-coated tablets Ipratropium bromide (Ph.Eur.); salbutamol sulfate Change notification 04.11.2025 Production problem COMBIPRASAL 0.5 mg / 2.5 mg solution for nebulizer Ipratropium bromide Change notification 04.11.2025 Production problem Ipratropium bromide 250 micrograms / 1 ml Stulln Levetiracetam Initial report 04.11.2025 Other Levetiracetam Holsten 750 mg film-coated tablets Amlodipine besylate; hydrochlorothiazide; valsartan Initial report 04.11.2025 Other Amlodipine/Valsartan/HCT Holsten 5 mg/160 mg/12.5 mg film-coated tablets Docetaxel Initial report 04.11.2025 Production problem Docetaxel Aurobindo 20 mg/ml concentrate for solution for infusion Venlafaxine hydrochloride Initial report 04.11.2025 Other Venlafaxine Aurobindo 75 mg hard capsule, delayed release Topiramate Initial report 04.11.2025 Other Topiramate PUREN 50 mg film-coated tablets Tranexamic acid Initial report 04.11.2025 Production problem Tranexamic acid PUREN 100 mg/ml solution for injection Duloxetine hydrochloride Initial report 04.11.2025 Other Duloxetine PUREN 60 mg gastro-resistant hard capsules Anastrozole Initial report 04.11.2025 Production problem AnastroPUREN 1 mg film-coated tablets Duloxetine hydrochloride Initial report 04.11.2025 Other Duloxetine PUREN 30 mg gastro-resistant hard capsules Quetiapine fumarate (Ph.Eur.) Change notification 04.11.2025 Other Seroquel Prolong 200 mg prolonged-release tablets Insulin lispro Initial report 04.11.2025 Other Humalog KwikPen 100 E/ml solution for injection – OP (5x3ml) Olanzapine Change notification 04.11.2025 Production problem ZYPREXA Ipratropium bromide (Ph.Eur.); salbutamol sulfate Initial report 04.11.2025 Other Ipratropium/salbutamol Cipla 0.5 mg/2.5 mg solution for nebulizer Cefazolin sodium Initial report 04.11.2025 Production problem Cefazolin Hikma 2 g powder for solution for injection/infusion Amiodarone hydrochloride Initial report 04.11.2025 Other Amiodarone PUREN 200 mg tablets Atorvastatin calcium trihydrate (Ph.Eur.) Initial report 04.11.2025 Other Atorvastatin PUREN 80 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 04.11.2025 Other Atorvastatin PUREN 20 mg film-coated tablets Methylphenidate hydrochloride Change notification 04.11.2025 Other Methylphenidate hydrochloride HEXAL 36 mg prolonged-release tablets Atomoxetine hydrochloride Change notification 04.11.2025 Other Atomoxe – 1 A Pharma 100 mg hard capsules Topiramate Change notification 04.11.2025 Production problem Topiramate PUREN 100 mg film-coated tablets Atomoxetine hydrochloride Change notification 04.11.2025 Other Atomoxe – 1 A Pharma 18 mg hard capsules Atomoxetine hydrochloride Change notification 04.11.2025 Other Atomoxe – 1 A Pharma 25 mg hard capsules Atomoxetine hydrochloride Change notification 04.11.2025 Other Atomoxe – 1 A Pharma 40 mg hard capsules Quetiapine fumarate (Ph.Eur.) Change notification 04.11.2025 Other Seroquel Prolong 400 mg prolonged-release tablets Atomoxetine hydrochloride Change notification 04.11.2025 Other Atomoxe – 1 A Pharma 60 mg hard capsules Atomoxetine hydrochloride Change notification 04.11.2025 Other Atomoxe – 1 A Pharma 80 mg hard capsules Urapidil Change notification 04.11.2025 Production problem Urapidil Bluefish 30 mg hard capsules, delayed release Urapidil Change notification 04.11.2025 Production problem Urapidil Bluefish 90 mg hard capsules, delayed release Quetiapine fumarate (Ph.Eur.) Initial report 04.11.2025 Other Seroquel Prolong 150 mg prolonged-release tablets Aprepitant Initial report 03.11.2025 Production problem Aprepitant Zentiva 80 mg hard capsules Aprepitant Initial report 03.11.2025 Production problem Aprepitant Zentiva 125 mg hard capsules Aprepitant Change notification 03.11.2025 Production problem Aprepitant Zentiva 80 mg and 125 mg hard capsules Dimenhydrinate Initial report 03.11.2025 Production problem Dimenhydrinate PANPHARMA 6.2 mg/ml solution for injection (i.v.) Zonisamide Initial report 03.11.2025 Production problem Zonisamide Glenmark 100 mg hard capsules Anastrozole Change notification 03.11.2025 Other Anastrozole Denk 1 mg film-coated tablets Perindopril tert-butylamine Initial report 03.11.2025 Other Perindopril Erbumine Glenmark 4 mg tablets Riluzole Initial report 03.11.2025 Other Glentek 50 mg film-coated tablets Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y) Change notification 03.11.2025 Other Ferrlecit 62.5 mg Clonidine hydrochloride Change notification 03.11.2025 Other Clonidine-ratiopharm 75 Rizatriptan benzoate Change notification 03.11.2025 Production problem Rizatriptan Glenmark 5 mg tablets Clonidine hydrochloride Change notification 03.11.2025 Other Clonidine-ratiopharm 150 Rizatriptan benzoate Change notification 03.11.2025 Production problem Rizatriptan Glenmark 5 mg orodispersible tablets Clonidine hydrochloride Change notification 03.11.2025 Other Clonidine-ratiopharm 300 Rizatriptan benzoate Change notification 03.11.2025 Production problem Rizatriptan Glenmark 10 mg orodispersible tablets Rizatriptan benzoate Change notification 03.11.2025 Production problem Rizatriptan Glenmark 10 mg tablets Quetiapine fumarate (Ph.Eur.) Change notification 03.11.2025 Production problem Quetiapine Glenmark 200 mg prolonged-release tablets Fusidic acid (Ph.Eur.) Change notification 03.11.2025 Production problem Fucithalmic 10 mg/g eye drops Dexketoprofen trometamol Change notification 03.11.2025 Production problem Sympal inject 50 mg solution for injection/infusion Hydrocortisone acetate (Ph.Eur.) Change notification 03.11.2025 Production problem Hydrocortisone-POS N 2.5% Dexamethasone dihydrogen phosphate disodium (Ph.Eur.); gentamicin sulfate Change notification 03.11.2025 Production problem Dexa-Gentamicin Prednisolone acetate Change notification 03.11.2025 Production problem Predni-POS 1% Aciclovir Change notification 03.11.2025 Production problem Virupos Fluorometholone Change notification 03.11.2025 Production problem Fluoropos Gentamicin sulfate Change notification 03.11.2025 Production problem Gentamicin-POS Phenylephrine hydrochloride Change notification 03.11.2025 Production problem Neosynephrine-POS 5% - 2025.11.03
Active ingredients Message type Date of last message Type of reason AM designation Nimodipine Change notification 31.10.2025 Other Nimotop S Galantamine hydrobromide Change notification 31.10.2025 Other Galantamine – 1A Pharma 24 mg delayed-release hard capsules Nimodipine Initial report 31.10.2025 Other Nimotop Galantamine hydrobromide Change notification 31.10.2025 Other Galantamine – 1A Pharma 16 mg delayed-release hard capsules Sertraline hydrochloride Initial report 31.10.2025 Other Zoloft 20 mg/ml concentrate for oral solution Ciprofloxacin hydrochloride monohydrate Change notification 30.10.2025 Other CIPRO BASICS 750 mg film-coated tablets Ciprofloxacin hydrochloride monohydrate Change notification 30.10.2025 Other CIPRO BASICS 250 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 30.10.2025 Other ATORVASTATIN BASICS 80 mg film-coated tablets Ezetimibe; simvastatin Change notification 30.10.2025 Production problem EZETIMIB/SIMVA BASICS 10 mg/80 mg tablets Ezetimibe; simvastatin Change notification 30.10.2025 Production problem EZETIMIB/SIMVA BASICS 10 mg/40 mg tablets Ezetimibe; simvastatin Change notification 30.10.2025 Production problem EZETIMIB/SIMVA BASICS 10 mg/20 mg tablets Ezetimibe; simvastatin Change notification 30.10.2025 Production problem EZETIMIBE/SIMVA BASICS 10 mg/10 mg tablets Esomeprazole hemimagnesium Change notification 30.10.2025 Production problem ESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsules Esomeprazole hemimagnesium Change notification 30.10.2025 Production problem ESOMEPRAZOLE BASICS 40 mg gastro-resistant hard capsules Isotretinoin Change notification 30.10.2025 Other ISOTRETINOIN BASICS 10 mg soft capsules Isophan insulin suspension for injection (Ph.Eur.) Initial report 30.10.2025 Other Protaphane Penfill 100 IU/ml injection suspension in cylinder ampoule – OP(10x3ml) Flecainide acetate Change notification 30.10.2025 Other Tambocor Moxifloxacin hydrochloride (Ph.Eur.) ((with information on water content (1:x))) Change notification 30.10.2025 Other Moxifloxacin Holsten 400 mg film-coated tablets Doxepin hydrochloride (Ph.Eur.) Initial report 30.10.2025 Other Doxepin 50 Holsten Alprazolam Change notification 30.10.2025 Other Alprazolam – 1 A Pharma 1 mg tablets Oxcarbazepine Change notification 30.10.2025 Other Oxcarbazepine – 1 A Pharma 60 mg/ml oral suspension Flutamide Change notification 30.10.2025 Production problem FLUTA-cell 250 mg tablets Voriconazole Initial report 29.10.2025 Other VFEND 200 mg film-coated tablets Doxepin hydrochloride (Ph.Eur.) Change notification 29.10.2025 Other Doxepin 75 Holsten Doxepin hydrochloride (Ph.Eur.) Change notification 29.10.2025 Production problem Doxepin 25 Holsten Methylphenidate hydrochloride Change notification 29.10.2025 Other Methylphenidate AL 36 mg prolonged-release tablets Methylphenidate hydrochloride Change notification 29.10.2025 Other Metiphenal 10 mg modified-release hard capsules Posaconazole Change notification 29.10.2025 Other Posaconazole AL 40 mg/ml oral suspension Methylphenidate hydrochloride Change notification 29.10.2025 Other Methylphenidate AL 27 mg prolonged-release tablets Aprepitant Change notification 29.10.2025 Other Aprepitant AL 80 mg hard capsules Levothyroxine sodium Change notification 28.10.2025 Production problem L-thyroxine Henning 125 (4′-O-(13)C)Methacetin Change notification 28.10.2025 Production problem LiMAxetin 4 mg/ml solution for injection Besilesomab Initial report 28.10.2025 Production problem Scintimun Besilesomab Initial report 28.10.2025 Production problem Scintimun Levetiracetam Change notification 28.10.2025 Other Levetiracetam – 1 A Pharma 1500 mg film-coated tablets Olanzapine embonate monohydrate Initial report 28.10.2025 Production problem ZYPADHERA 210 mg powder and solvent for the preparation of a prolonged-release suspension for injection – OP(483mg+3ml) Paliperidone palmitate Initial report 28.10.2025 Other Paliperidone AL 25 mg prolonged-release injection suspension in a pre-filled syringe Paliperidone palmitate Change notification 28.10.2025 Other Paliperidone AL 50 mg depot injection suspension in a pre-filled syringe Olanzapine Change notification 28.10.2025 Production problem ZYPREXA Fluphenazine decanoate Change notification 28.10.2025 Production problem Fluphenazine-neuraxpharm D 50 mg/0.5 ml Fluphenazine decanoate Change notification 28.10.2025 Production problem Fluphenazine-neuraxpharm D 12.5 mg/0.5 ml Fluphenazine decanoate Change notification 28.10.2025 Production problem Fluphenazine-neuraxpharm D 25 mg/ml Fluphenazine decanoate Change notification 28.10.2025 Production problem Fluphenazine-neuraxpharm D 100 mg/ml Atomoxetine hydrochloride Change notification 28.10.2025 Production problem Atomoxetine-neuraxpharm 60 mg hard capsules Atomoxetine hydrochloride Change notification 28.10.2025 Production problem Atomoxetine-neuraxpharm 10 mg hard capsules Atomoxetine hydrochloride Change notification 28.10.2025 Production problem Atomoxetine-neuraxpharm 18 mg hard capsules Atomoxetine hydrochloride Change notification 28.10.2025 Production problem Atomoxetine-neuraxpharm 25 mg hard capsules Atomoxetine hydrochloride Change notification 28.10.2025 Production problem Atomoxetine-neuraxpharm 40 mg hard capsules Atomoxetine hydrochloride Change notification 28.10.2025 Production problem Atomoxetine-neuraxpharm 80 mg hard capsules Atomoxetine hydrochloride Change notification 28.10.2025 Production problem Atomoxetine-neuraxpharm 100 mg hard capsules Haloperidol decanoate Change notification 28.10.2025 Production problem Haloperidol-neuraxpharm decanoate 50 mg/ml Haloperidol decanoate Change notification 28.10.2025 Production problem Haloperidol-neuraxpharm decanoate 100 mg/ml Quetiapine fumarate (Ph.Eur.) Change notification 28.10.2025 Other Quetiapine-neuraxpharm 50 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 28.10.2025 Other Quetiapine-neuraxpharm 150 mg prolonged-release tablets Flutamide Change notification 28.10.2025 Other Flutamide AL 250 Quetiapine fumarate (Ph.Eur.) Change notification 28.10.2025 Other Quetiapine-neuraxpharm 200 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 28.10.2025 Other Quetiapine-neuraxpharm 300 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 28.10.2025 Other Quetiapine-neuraxpharm 400 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 28.10.2025 Other Quetiapine-neuraxpharm 600 mg prolonged-release tablets Biperiden hydrochloride Change notification 28.10.2025 Production problem Biperiden-neuraxpharm 2 mg Biperiden hydrochloride Change notification 28.10.2025 Production problem Biperiden-neuraxpharm 4 mg Methylphenidate hydrochloride Change notification 28.10.2025 Other Methylphenidate hydrochloride-neuraxpharm 27 mg prolonged-release tablets Sodium (methylprednisolone-21-succinate) Change notification 28.10.2025 Other Urbason soluble forte 1000 mg Isosorbide mononitrate Change notification 28.10.2025 Production problem ISMN STADA 50 mg hard capsules, delayed release Aprepitant Change notification 28.10.2025 Production problem Aprepitant STADA 125 mg and 80 mg hard capsules Pramipexole dihydrochloride monohydrate Change notification 28.10.2025 Production problem Pramipexole STADA 0.52 mg prolonged-release tablets Aprepitant Change notification 28.10.2025 Production problem Aprepitant STADA 80 mg hard capsules Aprepitant Change notification 28.10.2025 Production problem Aprepitant STADA 125 mg hard capsules Gabapentin Change notification 27.10.2025 Other Gabapentin Holsten 100 mg hard capsules Tetrabenazine Initial report 27.10.2025 Other Tetrabenazine Aristo 25 mg tablets Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y) Change notification 27.10.2025 Other Ferrlecit 62.5 mg Cefaclor monohydrate Change notification 27.10.2025 Other Cefaclor 125 TS – 1 A Pharma Methyldopa (Ph.Eur.) Change notification 27.10.2025 Other Dopegyt tablets Insulin glargine Change notification 27.10.2025 Other Semglee 100 units/ml solution for injection in pre-filled pen – OP(5x3ml) Sufentanil citrate Initial report 27.10.2025 Production problem Sufenta mite Arsenic(III) oxide Change notification 27.10.2025 Production problem Arsenic trioxide STADA 1 mg/ml concentrate for solution for infusion - 2025.10.27
Active ingredients Message type Date of last message Type of reason AM designation Beclometasone dipropionate (Ph.Eur.) Initial report 24.10.2025 Other Beclorhinol aquosum 50 micrograms Rifampicin sodium Change notification 24.10.2025 Other Eremfat i.v. 600mg Nimodipine Initial report 24.10.2025 Other Nimodipine Hexal 30 mg Mivacurium chloride Change notification 23.10.2025 Production problem Mivacron 10mg Lorazepam Change notification 23.10.2025 Other Tavor 2.5 mg Expidet Quetiapine fumarate (Ph.Eur.) Change notification 23.10.2025 Other Quetiapine Hormosan 150 mg prolonged-release tablets Misoprostol Initial report 23.10.2025 Other Angusta 25 microgram tablets Epoetin beta Change notification 23.10.2025 Other NeoRecormon 5000 IU solution for injection in pre-filled syringe – OP6 Epoetin beta Change notification 23.10.2025 Other NeoRecormon 3000 IU solution for injection in pre-filled syringe – OP6 Epoetin beta Change notification 23.10.2025 Other NeoRecormon 4000 IU solution for injection in pre-filled syringe – OP6 Epoetin beta Change notification 23.10.2025 Other NeoRecormon 2000 IU solution for injection in pre-filled syringe – OP6 Insulin lispro Initial report 23.10.2025 Other Liprolog Mix25 100 IU/ml KwikPen injection suspension – OP[2x(5x3ml)] Thiamazole Initial report 22.10.2025 Other Thiamazole 5mg Henning Acetylcholine chloride Change notification 22.10.2025 Production problem Miochol-E Powder and solvent for the preparation of an instillation solution for intraocular use Thiamazole Initial report 22.10.2025 Other Thiamazole 20 mg Henning Quetiapine fumarate (Ph.Eur.) Initial report 22.10.2025 Production problem Quetiapine Accord 400 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Initial report 22.10.2025 Production problem Quetiapine Accord 200 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Initial report 22.10.2025 Production problem Quetiapine Accord 150 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 22.10.2025 Production problem Quetiapine Accord 50 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 22.10.2025 Production problem Quetiapine Accord 300 mg prolonged-release tablets Insulin glargine Change notification 22.10.2025 Other Semglee Pirfenidone Change notification 22.10.2025 Production problem Pirfenidone Accord 801 mg film-coated tablets Amikacin sulfate Change notification 22.10.2025 Production problem Amikacin B. Braun 5 mg/ml solution for infusion Amikacin sulfate Change notification 22.10.2025 Production problem Amikacin B. Braun 2.5 mg/ml solution for infusion Flutamide Initial report 22.10.2025 Other Flutamide AL 250 Carbamazepine Initial report 21.10.2025 Other Timonil Syrup Tinzaparin sodium Initial report 21.10.2025 Production problem innohep 20,000 Anti-Xa I.E./ml Vials Solution for injection Methylphenidate hydrochloride Change notification 21.10.2025 Other Equasym Retard 40 mg modified-release hard capsules Methyldopa (Ph.Eur.) Initial report 21.10.2025 Other Dopegyt tablets Ibuprofen Change notification 21.10.2025 Other IBU-PUREN acute 400 mg film-coated tablets Carbamazepine Change notification 21.10.2025 Other Carbadura 400 mg retard Methylphenidate hydrochloride Change notification 20.10.2025 Other METHYLPHENIDATE 20 mg tablets Human insulin (with manufacturing details) Initial report 20.10.2025 Other Berlinsulin H 30/70 3 ml pen Isotretinoin Initial report 20.10.2025 Other ISOTRETINOIN BASICS 10 mg soft capsules Fampridine Change notification 20.10.2025 Other FAMPRIDIN BASICS 10 mg prolonged-release tablets Pramipexole dihydrochloride monohydrate Change notification 20.10.2025 Other Pramipexole Mylan 0.26 mg prolonged-release tablets Pramipexole dihydrochloride monohydrate Change notification 20.10.2025 Other Pramipexole Mylan 0.52 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Initial report 20.10.2025 Other Seroquel Prolong 300 mg prolonged-release tablets Sodium (hydrocortisone-21-succinate) Change notification 20.10.2025 Production problem Hydrocortisone PANPHARMA 250 mg - 2025.10.20
Active ingredients Message type Date of last message Type of reason AM designation Lidocaine hydrochloride monohydrate Change notification 17.10.2025 Other Xylocaine Gel 2% Estriol Initial report 17.10.2025 Other Ovestin 1 mg cream Mivacurium chloride Initial report 17.10.2025 Other Mivacron 10 mg Lidocaine Initial report 17.10.2025 Other XYLOCAIN PUMP SPRAY dental Salbutamol sulfate Change notification 17.10.2025 Other Sultanol forte ready-to-use inhalation solution Levothyroxine sodium Initial report 17.10.2025 Production problem L-thyroxine Henning 50 Levothyroxine sodium Initial report 17.10.2025 Production problem L-thyroxine Henning 125 Levothyroxine sodium Initial report 17.10.2025 Production problem L-Thyroxine Henning 75 Gentamicin sulfate Initial report 17.10.2025 Production problem Gentamicin-POS Phenylephrine hydrochloride Change notification 17.10.2025 Production problem Neosynephrine-POS 5% Fampridine Change notification 17.10.2025 Other FAMPRIDIN BASICS 10 mg prolonged-release tablets Atorvastatin calcium trihydrate (Ph.Eur.) Initial report 17.10.2025 Other ATORVASTATIN BASICS 80 mg film-coated tablets Olanzapine embonate monohydrate Initial report 17.10.2025 Other ZYPADHERA 405 mg powder and solvent for the preparation of a prolonged-release injection suspension – OP(931mg+3ml) Candesartan cilexetil Initial report 17.10.2025 Other ATACAND 16 mg Olanzapine embonate monohydrate Change notification 17.10.2025 Production problem ZYPADHERA 210 mg powder and solvent for the preparation of a prolonged-release suspension for injection – OP(483mg+3ml) Methyldopa (Ph.Eur.) Initial report 17.10.2025 Production problem Presinol 250 Insulin detemir Initial report 17.10.2025 Other Levemir 100 IU solution for injection in pre-filled pen – OP(10x3ml)(FlexPen) Insulin detemir Initial report 17.10.2025 Other Levemir 100 IU injection solution in cartridge – OP(10x3ml) Betamethasone dipropionate (Ph.Eur.); gentamicin sulfate Initial report 16.10.2025 Other Diprogenta Posaconazole Initial report 16.10.2025 Other Posaconazole HEXAL 40 mg/ml oral suspension Oxytocin Initial report 16.10.2025 Production problem Oxytocin 3 IU Hexal Human insulin (with manufacturing details) Initial report 16.10.2025 Other Berlinsulin H Basal 3 ml pen Insulin aspart Change notification 16.10.2025 Other NovoMix 30 FlexPen 100 IU/ml injection suspension in pre-filled syringe – OP(10x3ml) Human insulin (with manufacturing details) Initial report 15.10.2025 Other Berlinsulin H Normal 3 ml pen Methylprednisolone Initial report 15.10.2025 Other Methylprednisolone 4mg JENAPHARM Azithromycin dihydrate Change notification 15.10.2025 Other Azithromycin AL 250 mg film-coated tablets Vancomycin hydrochloride Change notification 15.10.2025 Production problem Vancomycin Lyomark 500 mg Vancomycin hydrochloride Change notification 15.10.2025 Production problem Vancomycin Lyomark 1000 mg powder for concentrate for solution for infusion or oral solution Posaconazole Initial report 15.10.2025 Other Posaconazole AL 40 mg/ml oral suspension Methylphenidate hydrochloride Initial report 15.10.2025 Other Metiphenal 10 mg modified-release hard capsules Folic acid hydrate (with information on water content (1:x)) Initial report 15.10.2025 Other Folic acid AL 5 mg tablets Acitretin Initial report 15.10.2025 Other Acicutan 25 mg hard capsules Fusidic acid (Ph.Eur.) Initial report 15.10.2025 Other Fusicutan ointment Oxazepam Initial report 15.10.2025 Other Durazepam 50 mg forte Oxycodone hydrochloride (Ph.Eur.) Initial report 14.10.2025 Production problem Oxygesic Dispersa acute 5 mg Oxycodone hydrochloride (Ph.Eur.) Initial report 14.10.2025 Production problem Oxygesic Dispersa acute 10 mg Oxycodone hydrochloride Change notification 14.10.2025 Other OXYGESIC 10 mg Arsenic(III) oxide Initial report 14.10.2025 Other TRISENOX 2 mg/ml concentrate for solution for infusion Granisetron hydrochloride Initial report 14.10.2025 Other Kevatril 3 mg/3 ml solution for injection Carboplatin Initial report 14.10.2025 Other Carboplatin Kabi 10 mg/ml concentrate for solution for infusion Dexketoprofen trometamol Initial report 14.10.2025 Production problem Sympal inject 50 mg injection/infusion solution Tolterodine tartrate Initial report 14.10.2025 Other Detrusitol 2 mg film-coated tablets Doxepin hydrochloride (Ph.Eur.) Initial report 14.10.2025 Other Doxepin-ratiopharm 50 mg film-coated tablets Doxepin hydrochloride (Ph.Eur.) Initial report 14.10.2025 Other Doxepin-ratiopharm 25 mg film-coated tablets Thiamazole Initial report 13.10.2025 Other Thiamazole 5 mg Henning Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y) Change notification 13.10.2025 Other Ferrlecit 62.5 mg Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y) Change notification 13.10.2025 Other Ferrlecit 40 mg Cisatracurium besylate Change notification 13.10.2025 Other Nimbex 10 mg Zolbetuximab Change notification 13.10.2025 Other Vyloy Paliperidone palmitate Initial report 13.10.2025 Other XEPLION 50 mg prolonged-release suspension for injection – OP1ml