- 2025.07.14
Active ingredients Report type Date of last message Type of reason AM designation Methyl (5-amino-4-oxopentanoate) hydrochloride Initial report 11.07.2025 Other Metvix 160 mg/g cream Semaglutide Initial report 11.07.2025 Other Ozempic 1 mg injection solution in a pre-filled pen – OP(3x3ml) Salbutamol sulfate Change notification 11.07.2025 Other Sultanol inhalation solution Salbutamol sulfate Change notification 11.07.2025 Other Sultanol metered aerosol Flunisolid hemihydrate Change notification 11.07.2025 Other Syntaris Framycetin sulfate (Ph.Eur.) Change notification 11.07.2025 Other Leukase N ointment Human insulin (with manufacturing details); Isophane insulin suspension for injection (Ph.Eur.) Initial report 11.07.2025 Other Actraphane 30 FlexPen 100 IU/ml injection suspension in injector – OP(10x3ml) Insulin aspart Initial report 11.07.2025 Other NovoMix 30 FlexPen 100 IU/ml injection suspension in pre-filled syringe – OP(10x3ml) Promethazine hydrochloride Initial report 11.07.2025 Production problem Atosil injection solution N Paliperidone palmitate Initial report 11.07.2025 Other XEPLION 50 mg depot injection suspension – OP1ml Paliperidone palmitate Initial report 11.07.2025 Other XEPLION 25 mg depot injection suspension – OP1ml Ampicillin sodium Initial report 10.07.2025 Production problem Ampicillin Eberth 1 g powder for solution for injection/infusion Trometamol Initial report 10.07.2025 Other Tham-Köhler Trometamol Initial report 10.07.2025 Other THAM-Köhler 3 M Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 10.07.2025 Other Atorvastatin Aristo 60 mg film-coated tablets Cinacalcet hydrochloride Initial report 10.07.2025 Other Cinacalcet Mylan 60 mg film-coated tablets – OP(28×1) Pramipexole dihydrochloride monohydrate Change notification 10.07.2025 Other Pramipexole Mylan 0.52 mg prolonged-release tablets Pramipexole dihydrochloride monohydrate Change notification 10.07.2025 Other Pramipexole Mylan 0.26 mg prolonged-release tablets Trandolapril; verapamil hydrochloride Change notification 10.07.2025 Production problem Tarka 240 mg/2 mg modified-release tablets Sufentanil citrate Initial report 10.07.2025 Production problem Sufenta 50 micrograms/ml solution for injection Deferasirox Change notification 10.07.2025 Other Deferasirox Mylan 180 mg film-coated tablets Potassium canrenoate Change notification 10.07.2025 Production problem Aldactone 10 ml Canrenoate Oxazepam Change notification 10.07.2025 Other Oxazepam AL 10 Amoxicillin trihydrate Change notification 10.07.2025 Other Amoxicillin AL TS Isophane insulin suspension for injection (Ph.Eur.) Change notification 09.07.2025 Other Protaphane FlexPen 100 IU/ml injection suspension in injector – OP (10x3ml) Estriol Initial report 09.07.2025 Other Ovestin 1 mg cream Propofol Initial report 09.07.2025 Other DISOPRIVAN 1% Lidocaine hydrochloride monohydrate Initial report 09.07.2025 Other Xylocaine Gel 2% Azathioprine Initial report 09.07.2025 Other Imurek 25 mg film-coated tablets Levothyroxine sodium (Ph.Eur.) Initial report 09.07.2025 Other Thevier 100 Levothyroxine sodium (Ph.Eur.) Initial report 09.07.2025 Other Thevier 50 Methylphenidate hydrochloride Initial report 09.07.2025 Other Methylphenidate-ratiopharm 20 mg modified-release hard capsules Methylphenidate hydrochloride Initial report 09.07.2025 Other Methylphenidate-ratiopharm 40 mg hard capsules with modified release Methyldopa (Ph.Eur.) Initial report 08.07.2025 Production problem Presinol 125 Methyldopa (Ph.Eur.) Initial report 08.07.2025 Production problem Presinol 500 Velmanase alfa Initial report 08.07.2025 Other Lamzede 10 mg powder for solution for infusion – OP(10×250,815mg) Doxepine hydrochloride (Ph.Eur.) Change notification 08.07.2025 Production problem Doxepin 25 Holsten Desflurane Initial report 08.07.2025 Production problem Suprane Carbamazepine Initial report 08.07.2025 Other Carbamazepine AL 400 retard Carbamazepine Initial report 08.07.2025 Other Carbamazepine AL 200 retard Quetiapine fumarate (Ph.Eur.) Change notification 08.07.2025 Other Quetiapine-ratiopharm 300 mg prolonged-release tablets Oxazepam Change notification 08.07.2025 Other Oxa-CT 10 mg tablets Quetiapine fumarate (Ph.Eur.) Change notification 08.07.2025 Other Quetiapine AbZ 150 mg prolonged-release tablets Calcium acetate hydrate ((with information on water content (1:x))) Initial report 07.07.2025 Production problem Renacet 950 mg Midodrine hydrochloride Initial report 07.07.2025 Other Gutron tablets DL-lysine acetylsalicylate – glycine (9:1) Initial report 07.07.2025 Production problem Acetylsalicylic acid Panpharma i.v. 500 mg Salbutamol sulfate Initial report 07.07.2025 Other Bronchospray Autohaler - 2025.07.07
Active ingredients Notification type Date of last notification Type of reason AM designation Fampridine Change notification 04.07.2025 Other Fampyra 10 mg prolonged-release tablets – OP28(2×14)(Bl) Dexamethasone; neomycin sulfate; polymyxin B sulfate Change notification 04.07.2025 Production problem Isopto-Max Olanzapine embonate monohydrate First notification 04.07.2025 Production problem ZYPADHERA 210 mg powder and solvent for the preparation of a suspension for depot injection – OP(483mg+3ml) Acetylcholine chloride Change notification 04.07.2025 Production problem Miochol-E Powder and solvent for the preparation of an instillation solution for intraocular use Terazosin hydrochloride dihydrate Change notification 04.07.2025 Other Heitrin 1mg Terazosin hydrochloride dihydrate Change notification 04.07.2025 Other Heitrin 5mg Terazosin hydrochloride dihydrate Change notification 04.07.2025 Other Heitrin 2mg Nitrendipine Change notification 04.07.2025 Production problem Nitrendipine Aristo 10 mg film-coated tablets Rivastigmine hydrogentartrate Change notification 04.07.2025 Production problem Rivastigmine Aurobindo 6 mg hard capsules Celecoxib Change notification 04.07.2025 Production problem Celecoxib Aurobindo 200 mg hard capsules Duloxetine hydrochloride Change notification 04.07.2025 Production problem Duloxetine PUREN 40 mg enteric-coated hard capsules Duloxetine hydrochloride Change notification 04.07.2025 Production problem Duloxetine Aurobindo 60 mg enteric-coated hard capsules Methylphenidate hydrochloride Change notification 03.07.2025 Production problem Methysym Methylphenidate hydrochloride Change notification 03.07.2025 Production problem Methysym Methylphenidate hydrochloride Change notification 03.07.2025 Production problem Methysym Methylphenidate hydrochloride Change notification 03.07.2025 Production problem Methysym Methylphenidate hydrochloride Change notification 03.07.2025 Production problem Methysym Methylphenidate hydrochloride Change notification 03.07.2025 Production problem Methysym Terazosin hydrochloride dihydrate Change notification 03.07.2025 Other Tera TAD 2mg Terazosin hydrochloride dihydrate Change notification 03.07.2025 Other Tera TAD 5mg Terazosin hydrochloride dihydrate Change notification 03.07.2025 Other Tera TAD 10mg Cefotaxime sodium First notification 03.07.2025 Production problem Cefotaxime-saar 2 g Powder for solution for injection or infusion Fluoxetine hydrochloride First notification 03.07.2025 Other Fluoxetine beta 40 Fluoxetine hydrochloride First notification 03.07.2025 Other Fluoxetine beta 20 Zoledronic acid monohydrate First notification 03.07.2025 Other Zole – 1 A Pharma 5 mg/100 ml solution for infusion Zoledronic acid monohydrate First notification 03.07.2025 Other Aclasta 5 mg solution for infusion – OP(1x100ml) Insulin human ((with manufacturing details)) First notification 03.07.2025 Other Huminsulin Profile III KwikPen 100 IU/ml injection suspension Quetiapine fumarate (Ph.Eur.) First notification 03.07.2025 Production problem Quetiapine Glenmark 150 mg prolonged-release tablets Mometasone furoate (Ph.Eur.) Change notification 03.07.2025 Production problem Mometasone Glenmark 1mg/g ointment Urapidil Change notification 03.07.2025 Other Urapidil Stragen 30 mg delayed-release hard capsules Urapidil Change notification 03.07.2025 Other Urapidil Stragen 60 mg delayed-release hard capsules Thioctic acid trometamol salt (1:1) Change notification 03.07.2025 Other Thioctacid 600 T Solifenacin succinate Change notification 03.07.2025 Production problem Solifenacin succinate Aurobindo 5 mg film-coated tablets Prednisolone acetate Change notification 03.07.2025 Production problem Predni-POS 1 % Fluorometholone Change notification 03.07.2025 Production problem fluoropos Hydrocortisone acetate (Ph.Eur.) Change notification 03.07.2025 Production problem Hydrocortisone POS N 2.5% Dexamethasone dihydrogen phosphate disodium (Ph.Eur.); gentamicin sulphate Change notification 03.07.2025 Production problem Dexa-Gentamicin Acyclovir Change notification 03.07.2025 Production problem Virupos Clarithromycin Change notification 03.07.2025 Production problem CLARITHROMYCIN BASICS 250 mg/5 ml granules for the preparation of an oral suspension Esomeprazole hemimagnesium Change notification 03.07.2025 Production problem ESOMEPRAZOL BASICS 40 mg gastro-resistant hard capsules Esomeprazole hemimagnesium Change notification 03.07.2025 Production problem ESOMEPRAZOL BASICS 20 mg enteric-coated hard capsules Insulin lispro First notification 03.07.2025 Other Liprolog 100 E/ml solution for injection in cartridge – OP(5x3ml) Anti-human T-lymphocyte immunoglobulin from horse First notification 03.07.2025 Other Atgam Fluorouracil Change notification 03.07.2025 Other Benda-5 FU Vancomycin hydrochloride Change notification 03.07.2025 Production problem Vancomycin Lyomark 1000 mg powder for concentrate for solution for infusion or oral solution Vancomycin hydrochloride Change notification 03.07.2025 Production problem Vancomycin Lyomark 500 mg Fluorouracil Change notification 03.07.2025 Other Fluorouracil Hikma 50 mg/ml solution for injection Sodium (methylprednisolone-21-succinate) Change notification 02.07.2025 Other Urbason solubile forte 1000 mg Insulin glargine Change notification 02.07.2025 Other Semglee Salbutamol sulphate Change notification 02.07.2025 Other Sultanol metered dose aerosol Insulin glargine First notification 02.07.2025 Other Semglee 100 units/ml solution for injection in prefilled pen – OP(5x3ml) Ampicillin sodium Change notification 02.07.2025 Production problem Ampicillin Eberth 2 g powder for solution for injection/infusion Ampicillin sodium Change notification 02.07.2025 Production problem Ampicillin Eberth 500 mg powder for solution for injection/infusion Fosfomycin sodium (Ph.Eur.) Change notification 02.07.2025 Production problem Fosfomycin Eberth 2 g powder for solution for infusion Fosfomycin sodium (Ph.Eur.) Change notification 02.07.2025 Production problem Fosfomycin Eberth 4 g powder for solution for infusion Epoetin beta First notification 02.07.2025 Other NeoRecormon 3000 IU solution for injection in prefilled syringe – OP6 Ibandronate sodium monohydrate Change notification 02.07.2025 Other Bondronat 50 mg film-coated tablets – OP28 Methylphenidate hydrochloride First notification 02.07.2025 Other Methylphenidate AL 27 mg prolonged-release tablets Ipratropium bromide (Ph.Eur.) Change notification 02.07.2025 Production problem Ipratropium Teva 250 micrograms / 1 ml solution for nebulizer Buprenorphine Change notification 02.07.2025 Other Buprenorphine AWD Matrix 70 microgram/h transdermal patch Fluoxetine hydrochloride First notification 02.07.2025 Production problem Fluoxetine Stada 20 mg tablets for oral suspension Ribavirin First notification 02.07.2025 Other Ribavirin-ratiopharm 400 mg film-coated tablets Ribavirin Change notification 02.07.2025 Other Ribavirin-ratiopharm 200 mg film-coated tablets Buprenorphine Change notification 02.07.2025 Other Buprenorphine-ratiopharm 70 microgram/h transdermal patch Buprenorphine Change notification 02.07.2025 Other Buprenorphine-ratiopharm 52.5 micrograms/h transdermal patch Buprenorphine Change notification 02.07.2025 Other Buprenorphine-ratiopharm 35 micrograms/h transdermal patch Aprepitant First notification 02.07.2025 Production problem Aprepitant STADA 125 mg and 80 mg hard capsules Rizatriptan benzoate Change notification 01.07.2025 Production problem Rizatriptan Glenmark 5 mg tablets Rizatriptan benzoate Change notification 01.07.2025 Production problem Rizatriptan Glenmark 5 mg orodispersible tablets Rizatriptan benzoate Change notification 01.07.2025 Production problem Rizatriptan Glenmark 10 mg orodispersible tablets Rizatriptan benzoate Change notification 01.07.2025 Production problem Rizatriptan Glenmark 10 mg tablets Quetiapine fumarate (Ph.Eur.) Change notification 01.07.2025 Production problem Quetiapine Glenmark 200 mg prolonged-release tablets Linezolid Change notification 01.07.2025 Production problem Linezolid Glenmark 600 mg film-coated tablets Galantamine hydrobromide Change notification 01.07.2025 Production problem Galantamine Glenmark 16 mg hard capsules, delayed release Galantamine hydrobromide Change notification 01.07.2025 Production problem Galantamine Glenmark 8 mg hard capsules, delayed release Galantamine hydrobromide Change notification 01.07.2025 Production problem Galantamine Glenmark 24 mg hard capsules, delayed-release Trazodone hydrochloride Change notification 01.07.2025 Production problem Trazodone Glenmark 100 mg tablets Phenoxymethylpenicillin potassium Change notification 01.07.2025 Other Pen Mega – 1 A Pharma Aprepitant Change notification 01.07.2025 Other Aprepilor 80 mg hard capsules Aprepitant Change notification 01.07.2025 Other Aprepilor 125 mg/80 mg hard capsules Haloperidol decanoate Change notification 01.07.2025 Production problem Haloperidol-neuraxpharm decanoate 50 mg/ml Haloperidol decanoate Change notification 01.07.2025 Production problem Haloperidol neuraxpharm decanoate 100 mg/ml Quetiapine fumarate (Ph.Eur.) Change notification 01.07.2025 Other Quetiapine-neuraxpharm 50 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 01.07.2025 Other Quetiapine-neuraxpharm 150 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 01.07.2025 Other Quetiapine-neuraxpharm 200 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 01.07.2025 Other Quetiapine-neuraxpharm 300 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 01.07.2025 Other Quetiapine-neuraxpharm 400 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 01.07.2025 Other Quetiapine-neuraxpharm 600 mg prolonged-release tablets Galantamine hydrobromide Change notification 01.07.2025 Other Galantamine-neuraxpharm 8 mg delayed-release hard capsules Galantamine hydrobromide Change notification 01.07.2025 Other Galantamine-neuraxpharm 16 mg hard capsules, prolonged-release Galantamine hydrobromide Change notification 01.07.2025 Other Galantamine-neuraxpharm 24 mg hard capsules, delayed-release Atomoxetine hydrochloride Change notification 01.07.2025 Production problem Atomoxetine-neuraxpharm 10 mg hard capsules Paliperidone palmitate Change notification 01.07.2025 Other Paliperidone AL 150 mg depot injection suspension in a prefilled syringe Atomoxetine hydrochloride Change notification 01.07.2025 Production problem Atomoxetine-neuraxpharm 18 mg hard capsules Paliperidone palmitate Change notification 01.07.2025 Other Paliperidone AL 75 mg depot injection suspension in a prefilled syringe Atomoxetine hydrochloride Change notification 01.07.2025 Production problem Atomoxetine-neuraxpharm 25 mg hard capsules Paliperidone palmitate Change notification 01.07.2025 Other Paliperidone AL 50 mg depot injection suspension in a prefilled syringe Atomoxetine hydrochloride Change notification 01.07.2025 Production problem Atomoxetine-neuraxpharm 40 mg hard capsules Paliperidone palmitate Change notification 01.07.2025 Other Paliperidone AL 25 mg depot injection suspension in a prefilled syringe Atomoxetine hydrochloride Change notification 01.07.2025 Production problem Atomoxetine-neuraxpharm 80 mg hard capsules Atomoxetine hydrochloride Change notification 01.07.2025 Production problem Atomoxetine-neuraxpharm 100 mg hard capsules Pramipexole dihydrochloride monohydrate Change notification 01.07.2025 Other Pramipexole HEXAL 0.26 mg prolonged-release tablets Methylphenidate hydrochloride Change notification 01.07.2025 Production problem Equasym Retard 40 mg modified-release hard capsules Tranexamic acid Change notification 01.07.2025 Other Cyklokapron Mupirocin calcium (Ph.Eur.) Change notification 30.06.2025 Production problem Turixin Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 30.06.2025 Other Atorvastatin Micro Labs 10 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 30.06.2025 Other Atorvastatin Micro Labs 20 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 30.06.2025 Other Atorvastatin Micro Labs 30 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 30.06.2025 Other Atorvastatin Micro Labs 40 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 30.06.2025 Other Atorvastatin Micro Labs 60 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 30.06.2025 Other Atorvastatin Micro Labs 80 mg film-coated tablets Ipratropium bromide (Ph.Eur.); salbutamol sulphate First notification 30.06.2025 Production problem COMBIPRASAL 0.5 mg / 2.5 mg solution for nebulizer Ipratropium bromide First notification 30.06.2025 Production problem Ipratropium bromide 125 micrograms / 1 ml ampoule Ipratropium bromide First notification 30.06.2025 Production problem Ipratropium bromide 250 micrograms / 1 ml Stulln Quetiapine fumarate (Ph.Eur.) Change notification 30.06.2025 Other Seroquel Prolong 400 mg prolonged-release tablets Sertraline hydrochloride Change notification 30.06.2025 Other Sertraline TAD 100 mg film-coated tablets Sertraline hydrochloride Change notification 30.06.2025 Other Sertraline TAD 50 mg film-coated tablets Trimipramine mesilate Change notification 30.06.2025 Other Trimipramine – 1 A Pharma 40 mg/ml Oral drops, solution Doxorubicin hydrochloride Change notification 30.06.2025 Other Doxorubicin HEXAL 2 mg/ml Hydromorphone hydrochloride Change notification 30.06.2025 Other Hydromorphone HEXAL 2.6 mg hard capsules Terbutaline sulphate (Ph.Eur.) Change notification 30.06.2025 Production problem BRICANYL 0.5 mg Chlortalidone Change notification 30.06.2025 Other Chlortalidone HEXAL 25 mg tablets Chlortalidone Change notification 30.06.2025 Other Chlortalidone HEXAL 50 mg tablets - 2025.06.30
Active ingredients Notification type Date of last notification Type of reason AM designation Oxycodone hydrochloride (Ph.Eur.) Change notification 27.06.2025 Other Oxygesic 5 mg Hydromorphone hydrochloride Change notification 27.06.2025 Other Palladon 2.6 mg hard capsules Quetiapine fumarate (Ph.Eur.) Change notification 27.06.2025 Other Seroquel Prolong 50 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 27.06.2025 Other Seroquel Prolong 200 mg prolonged-release tablets Liraglutide First notification 27.06.2025 Other Saxenda 6 mg/ml solution for injection in prefilled pen – OP(5x3ml) Insulin human ((with manufacturing information)) First notification 27.06.2025 Other Actrapid Penfill 100 I.U./ml solution for injection in cylinder ampoule – OP(10x3ml) Liraglutide Change notification 27.06.2025 Other Saxenda 6 mg/ml solution for injection in prefilled pen – OP(3x3ml) Procaine hydrochloride Change notification 26.06.2025 Other Procaine 2% JENAPHARM Procaine hydrochloride Change notification 26.06.2025 Other Procaine 1 % JENAPHARM Human fibrinogen Change notification 26.06.2025 Other FibCLOT Ciclosporin Change notification 26.06.2025 Other Ciclosporin dura 25 mg soft capsules Dacarbazine citrate Change notification 26.06.2025 Production problem Dacarbazine Lipomed 500 mg powder for solution for infusion Galantamine hydrobromide Change notification 25.06.2025 Production problem Galantamine Heumann 24 mg hard capsules, retarded Lorazepam Change notification 25.06.2025 Other Tavor 2.5 mg Expidet Diclofenac sodium First notification 25.06.2025 Other Voltaren 50 mg suppository Everolimus First notification 25.06.2025 Production problem Votubia 5 mg tablets for oral suspension – OP30 Oxycodone hydrochloride (Ph.Eur.) First notification 25.06.2025 Production problem Oxycodone hydrochloride – 1 A Pharma 5 mg prolonged-release tablets Galantamine hydrobromide Change notification 25.06.2025 Production problem Galantamine Heumann 16 mg hard capsules, retarded Galantamine hydrobromide Change notification 25.06.2025 Production problem Galantamine Heumann 8 mg hard capsules, retarded Oxycodone hydrochloride (Ph.Eur.) First notification 25.06.2025 Other Oxycodone hydrochloride – 1 A Pharma 10 mg prolonged-release tablets Aprepitant Change notification 25.06.2025 Production problem Aprepitant STADA 125 mg and 80 mg hard capsules Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 25.06.2025 Production problem Atorvastatin STADA 80 mg film-coated tablets Sodium mycophenolate Change notification 25.06.2025 Other Mycophenolic acid HEXAL 360 mg enteric-coated tablets Ciclosporin Change notification 25.06.2025 Other Ciclosporin Hexal 100 mg Salbutamol sulfate Change notification 25.06.2025 Other Salbutamol AL inhalation Methylphenidate hydrochloride Change notification 25.06.2025 Other Methylene dihydrochloride HEXAL 36 mg prolonged-release tablets Tacrolimus monohydrate Change notification 25.06.2025 Other Tacrolimus AL 0.5 mg Hard capsules, prolonged-release Tacrolimus monohydrate Change notification 25.06.2025 Other Tacrolimus AL 1 mg hard capsules, delayed-release Tacrolimus monohydrate Change notification 25.06.2025 Other Tacrolimus AL 3 mg hard capsules, prolonged-release Tacrolimus monohydrate Change notification 25.06.2025 Other Tacrolimus AL 5 mg hard capsules, prolonged-release Quetiapine fumarate (Ph.Eur.) Change notification 25.06.2025 Other Quetiapine AL 150 mg prolonged-release tablets Cefixime 3 H<2>O Change notification 25.06.2025 Other Cefixim AL 100 mg/5 ml Powder for oral suspension Sugammadex sodium First notification 25.06.2025 Production problem Sugammadex Amomed Ipratropium bromide (Ph.Eur.) Change notification 25.06.2025 Production problem Ipratropium Teva 250 micrograms / 1 ml solution for a nebulizer Epinephrine/adrenaline Change notification 25.06.2025 Production problem Anapen 500 micrograms solution for injection Risperidone Change notification 25.06.2025 Production problem Risperidon-ratiopharm 50 mg powder and solvent for the preparation of a depot injection suspension Risperidone Change notification 25.06.2025 Production problem Risperidone-ratiopharm 37.5 mg powder and solvent for the preparation of a suspension for depot injection Risperidone Change notification 25.06.2025 Production problem Risperidone-ratiopharm 25 mg powder and solvent for the preparation of a depot suspension for injection Azithromycin dihydrate Change notification 25.06.2025 Other Azithromycin-ratiopharm 500 mg film-coated tablets Pramipexole dihydrochloride monohydrate Change notification 25.06.2025 Other Pramipexole-ratiopharm 0.26 mg prolonged-release tablets Galantamine hydrobromide Change notification 25.06.2025 Other Galantamine-ratiopharm 16 mg hard capsules, retarded Galantamine hydrobromide Change notification 25.06.2025 Other Galantamine-ratiopharm 24 mg hard capsules, delayed-release Galantamine hydrobromide Change notification 25.06.2025 Other Galantamine-ratiopharm 8 mg hard capsules, delayed-release Methylphenidate hydrochloride Change notification 25.06.2025 Other Methylphenidate AL 18 mg prolonged-release tablets Chlortalidone Change notification 24.06.2025 Other Chlortalidone HEXAL 50 mg tablets Chlortalidone First notification 24.06.2025 Other Chlortalidone HEXAL 25 mg tablets Chlortalidone First notification 24.06.2025 Other Chlortalidone HEXAL 12.5 mg tablets Phenylephrine hydrochloride Change notification 24.06.2025 Production problem Neosynephrine-POS 10% Fluoxetine hydrochloride First notification 24.06.2025 Production problem Fluoxetine-neuraxpharm 40 mg Fluoxetine hydrochloride First notification 24.06.2025 Production problem Fluoxetine-neuraxpharm 20 mg T Fluoxetine hydrochloride First notification 24.06.2025 Production problem Fluoxetine-neuraxpharm 20 mg Fluoxetine hydrochloride First notification 24.06.2025 Production problem Fluoxetine-neuraxpharm 10 mg Paliperidone palmitate First notification 24.06.2025 Other Niapelf Flecainide acetate First notification 24.06.2025 Other Tambocor Paliperidone palmitate First notification 24.06.2025 Other Niapelf Darifenacin hydrobromide First notification 24.06.2025 Other Emselex 7.5 mg prolonged-release tablets – OP49 Mometasone furoate (Ph.Eur.) First notification 24.06.2025 Other Momecutan solution Terbutaline sulphate (Ph.Eur.) First notification 23.06.2025 Production problem BRICANYL 0.5 mg Adenosine Change notification 23.06.2025 Production problem Adenosine Altamedics 30 mg/10 ml solution for infusion Praziquantel First notification 23.06.2025 Other Biltricide Azithromycin dihydrate Change notification 23.06.2025 Other Azithromycin HEXAL 200 mg/5 ml Powder for oral suspension Acemetacin First notification 23.06.2025 Other Rantudil forte - 2025.06.23
Active ingredients Message type Date of the last message Type of reason Pramipexole dihydrochloride monohydrate Change notification 20.06.2025 Other Pramipexole dihydrochloride monohydrate Initial notification 20.06.2025 Other Voriconazole Initial notification 20.06.2025 Other Vancomycin hydrochloride Change notification 20.06.2025 Other Aprepitant Change notification 19.06.2025 Other Hydromorphone hydrochloride Change notification 18.06.2025 Other Doxorubicin hydrochloride Change notification 18.06.2025 Other Enalapril maleate; hydrochlorothiazide Initial notification 18.06.2025 Production problem Quetiapine fumarate (Ph.Eur.) Change notification 18.06.2025 Production problem Tropicamide Change notification 18.06.2025 Production problem Rifampicin sodium Initial notification 18.06.2025 Other Levetiracetam Change notification 17.06.2025 Other Propranolol hydrochloride Initial notification 17.06.2025 Other Mepivacaine hydrochloride Change notification 17.06.2025 Production problem Phenoxybenzamine hydrochloride Initial notification 16.06.2025 Other Salbutamol sulfate Change notification 16.06.2025 Other Atenolol; chlorthalidone Change notification 16.06.2025 Other - 2025.06.15
Active ingredients Message type Date of the last message Type of reason Trimipramine mesilate Change notification 13.06.2025 Other Methylphenidate hydrochloride Change notification 13.06.2025 Other Hydromorphone hydrochloride Change notification 13.06.2025 Other Prednisolone acetate Change notification 13.06.2025 Production problem Fenoterol hydrobromide Initial notification 13.06.2025 Production problem Paliperidone palmitate Change notification 13.06.2025 Other Paliperidone palmitate Change notification 13.06.2025 Other Norepinephrine hydrochloride/norepinephrine hydrochloride Initial notification 12.06.2025 Production problem Epinephrine hydrochloride Initial notification 12.06.2025 Production problem Methylphenidate hydrochloride Change notification 12.06.2025 Other Proxymetacaine hydrochloride Initial notification 12.06.2025 Production problem Aprepitant Initial notification 12.06.2025 Other Emtricitabine; tenofovir disoproxil maleate Change notification 12.06.2025 Other Mepivacaine hydrochloride Change notification 12.06.2025 Production problem Articaine hydrochloride; epinephrine hydrogen tartrate/adrenaline hydrogen tartrate Change notification 12.06.2025 Production problem Prednisolone Change notification 12.06.2025 Production problem (2-Aminoethyl)dihydrogen phosphate calcium salt (1:1) Initial notification 12.06.2025 Other Sertraline hydrochloride Change notification 12.06.2025 Production problem Duloxetine hydrochloride Change notification 12.06.2025 Production problem Aprepitant Change notification 12.06.2025 Production problem Sertraline hydrochloride Change notification 12.06.2025 Production problem Isophane insulin suspension for injection (Ph.Eur.) Initial notification 12.06.2025 Production problem Insulin aspart Change notification 12.06.2025 Other Eptacog alfa (activated) Initial notification 12.06.2025 Other Mupirocin calcium (Ph.Eur.) Initial notification 11.06.2025 Production problem Salbutamol sulfate Initial notification 11.06.2025 Other Trospium chloride Initial notification 11.06.2025 Other Betamethasone dipropionate (Ph.Eur.); calcipotriol monohydrate Change notification 11.06.2025 Other Flunisolide hemihydrate Initial notification 11.06.2025 Other Pramipexole dihydrochloride monohydrate Change notification 11.06.2025 Other Betamethasone valerate (Ph.Eur.) Change notification 11.06.2025 Other Methylphenidate hydrochloride Change notification 10.06.2025 Other Paliperidone palmitate Initial notification 10.06.2025 Other Doxylamine hydrogen succinate Initial notification 10.06.2025 Production problem Thioctic acid trometamol salt (1:1) Change notification 10.06.2025 Other Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 09.06.2025 Other - 2025.06.09
Active ingredients Message type Date of the last message Type of reason Sodium perchlorate 1 H<2>O Change notification 08.06.2025 Other Insulin lispro Initial notification 06.06.2025 Other Methyldopa (Ph.Eur.) Change notification 06.06.2025 Production problem Insulin lispro Initial notification 06.06.2025 Other Insulin human ((with details of manufacture)) Initial notification 06.06.2025 Other Quetiapine fumarate (Ph.Eur.) Change notification 06.06.2025 Production problem Nitrendipine Initial notification 05.06.2025 Production problem Calcium chloride dihydrate; magnesium chloride hexahydrate; sodium chloride; sodium hydrogen carbonate Initial notification 05.06.2025 Other Bortezomibmannitol Initial notification 05.06.2025 Production problem Amoxicillin trihydrate Initial notification 05.06.2025 Production problem Remifentanil hydrochloride Initial notification 04.06.2025 Production problem Methylphenidate hydrochloride Change notification 04.06.2025 Other Mesalazine Initial notification 03.06.2025 Other Vancomycin hydrochloride Initial notification 03.06.2025 Other Potassium canrenoate Initial notification 03.06.2025 Production problem Spironolactone Change notification 03.06.2025 Production problem Epoetin beta Initial notification 03.06.2025 Other Pramipexole dihydrochloride monohydrate Change notification 03.06.2025 Production problem Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 03.06.2025 Production problem Sertraline hydrochloride Change notification 03.06.2025 Production problem Phenylephrine hydrochloride Initial notification 03.06.2025 Production problem Vancomycin hydrochloride Change notification 03.06.2025 Other Insulin glargine Initial notification 02.06.2025 Other Insulin human ((with details of manufacture)) Initial notification 02.06.2025 Other Insulin lispro Initial notification 02.06.2025 Other Paliperidone palmitate Initial notification 02.06.2025 Production problem Insulin lispro Initial notification 02.06.2025 Other Insulin glargine Initial notification 02.06.2025 Other Mepivacaine hydrochloride Change notification 02.06.2025 Production problem Articaine hydrochloride; epinephrine hydrogen tartrate/adrenaline hydrogen tartrate Change notification 02.06.2025 Production problem Salbutamol sulfate Change notification 02.06.2025 Other Prednisolone Change notification 02.06.2025 Production problem Rosuvastatin-Hemicalcium Change notification 02.06.2025 Other Betamethasone dipropionate (Ph.Eur.); calcipotriol monohydrate Initial notification 02.06.2025 Other Framycetin sulphate (Ph.Eur.) Initial notification 02.06.2025 Other Betamethasone dipropionate (Ph.Eur.); salicylic acid Change notification 02.06.2025 Other Phenoxymethylpenicillin potassium Change notification 02.06.2025 Other - 2025.06.02
Active ingredients Date of the last message Type of reason Oxycodone hydrochloride (Ph.Eur.) 30.05.2025 Other Naloxone hydrochloride dihydrate; oxycodone hydrochloride (Ph.Eur.) 30.05.2025 Other Ampicillin sodium 30.05.2025 Production problem Vibegron 28.05.2025 Production problem Insulin aspart 28.05.2025 Other Reproterol hydrochloride 28.05.2025 Production problem Carbamazepine 28.05.2025 Other Naloxegol oxalate 28.05.2025 Production problem Carbamazepine 28.05.2025 Other Methylphenidate hydrochloride 28.05.2025 Other Aprepitant 28.05.2025 Other Quetiapine fumarate (Ph.Eur.) 28.05.2025 Other Tamoxifen citrate 28.05.2025 Other Paliperidone palmitate 28.05.2025 Other Penicillamine 27.05.2025 Other Pramipexole dihydrochloride monohydrate 27.05.2025 Other Methylphenidate hydrochloride 27.05.2025 Other Phenobarbital 27.05.2025 Production problem Doxepin hydrochloride (Ph.Eur.) 27.05.2025 Other Biperidene hydrochloride 27.05.2025 Production problem Esomeprazole hemimagnesium 27.05.2025 Production problem Celecoxib 27.05.2025 Production problem Amoxicillin trihydrate; potassium clavulanate 27.05.2025 Production problem Urapidil 27.05.2025 Production problem Amoxicillin trihydrate 27.05.2025 Production problem Flucloxacillin sodium monohydrate 27.05.2025 Other Flucloxacillin sodium 1 H<2>O 27.05.2025 Production problem Duloxetine hydrochloride 27.05.2025 Production problem Atorvastatin calcium trihydrate (Ph.Eur.) 27.05.2025 Other - 2025.05.26
Active ingredients Message type Date of the last message Type of reason Arsenic(III) oxide Initial notification 23.05.2025 Production problem Ibandronate sodium monohydrate Change notification 23.05.2025 Other Fluphenazine decanoate Initial notification 23.05.2025 Production problem Fluphenazine decanoate Change notification 23.05.2025 Production problem Hydromorphone hydrochloride Change notification 23.05.2025 Other Moxifloxacin hydrochloride (Ph.Eur.) ((with details of water content (1:x))) Change notification 23.05.2025 Other Paliperidone palmitate Change notification 23.05.2025 Production problem Gentamicin sulphate Change notification 22.05.2025 Production problem Gentamicin sulphate Initial notification 22.05.2025 Production problem Insulin human ((with details of manufacture)) Initial notification 22.05.2025 Other Insulin aspart Change notification 22.05.2025 Other Insulin aspart Initial notification 22.05.2025 Other Betamethasone dipropionate (Ph.Eur.); salicylic acid Initial notification 22.05.2025 Other Betamethasone valerate (Ph.Eur.) Change notification 22.05.2025 Other Heparin sodium Initial notification 22.05.2025 Production problem Calcium acetate monohydrate Change notification 22.05.2025 Other Terazosin hydrochloride dihydrate Change notification 21.05.2025 Other Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 21.05.2025 Other Tizanidine hydrochloride Initial notification 21.05.2025 Other Acemetacin Change notification 21.05.2025 Production problem Clomethiazole hemiedisilate Change notification 21.05.2025 Other Midazolam hydrochloride Initial notification 20.05.2025 Production problem Sodium (methylprednisolone-21-succinate) Initial notification 20.05.2025 Other Atenolol; chlorthalidone Change notification 20.05.2025 Other Methylphenidate hydrochloride Change notification 20.05.2025 Other Dacarbazine citrate Change notification 19.05.2025 Production problem Quetiapine fumarate (Ph.Eur.) Change notification 19.05.2025 Other Salbutamol sulfate Change notification 19.05.2025 Other Ipratropium bromide (Ph.Eur.) Change notification 19.05.2025 Production problem Quetiapine fumarate (Ph.Eur.) Change notification 19.05.2025 Other Cinacalcethydrochloride Change notification 19.05.2025 Other Carbamazepine Change notification 19.05.2025 Other Methylphenidate hydrochloride Change notification 19.05.2025 Other Pramipexole dihydrochloride monohydrate Change notification 19.05.2025 Other Quetiapine fumarate (Ph.Eur.) Change notification 19.05.2025 Other - 2025.05.19
Active ingredients Message type Date of the last message Type of reason Moxifloxacin hydrochloride (Ph.Eur.) ((with details of water content (1:x))) Initial notification 16.05.2025 Other Levomethadone hydrochloride Change notification 16.05.2025 Other Sodium mucophenolate Change notification 16.05.2025 Other Hydromorphone hydrochloride Change notification 16.05.2025 Other Arsenic(III) oxide Initial notification 16.05.2025 Other Sodium (methylprednisolone-21-succinate) Initial notification 16.05.2025 Other Moxifloxacin hydrochloride (Ph.Eur.) ((with details of water content (1:x))) Change notification 15.05.2025 Production problem Insulin aspart Initial notification 15.05.2025 Other Salbutamol sulfate Change notification 15.05.2025 Other Methylphenidate hydrochloride Change notification 15.05.2025 Other Aprepitant Change notification 15.05.2025 Other Quetiapine fumarate (Ph.Eur.) Change notification 15.05.2025 Other Sertraline hydrochloride Initial notification 15.05.2025 Production problem Flupentixol decanoate Change notification 15.05.2025 Production problem Aprepitant Initial notification 14.05.2025 Other Epinephrine/adrenaline Change notification 14.05.2025 Production problem Erythromycin Change notification 14.05.2025 Other Trazodone hydrochloride Initial notification 14.05.2025 Other Tenofovir disoproxil Change notification 14.05.2025 Other Ezetimibe; Simvastatin Initial notification 14.05.2025 Production problem Methylphenidate hydrochloride Initial notification 14.05.2025 Production problem Zoledronic acid monohydrate Change notification 14.05.2025 Production problem Cyclophosphamide monohydrate Change notification 14.05.2025 Other Zoledronic acid monohydrate Change notification 14.05.2025 Production problem Metformin hydrochloride; sitagliptin hydrochloride monohydrate Change notification 14.05.2025 Other Morphine hemisulfate 2,5-hydrate Initial notification 13.05.2025 Other Sodium (methylprednisolone-21-succinate) Initial notification 13.05.2025 Other Prednisolone Initial notification 13.05.2025 Production problem Lorazepam Initial notification 13.05.2025 Other Mometasone furoate (Ph.Eur.) Change notification 12.05.2025 Production problem Tropicamide Change notification 12.05.2025 Production problem Rizatriptan benzoate Change notification 12.05.2025 Production problem Ezetimibe Change notification 12.05.2025 Production problem Atomoxetine hydrochloride Change notification 12.05.2025 Production problem Cyclopentolate hydrochloride Change notification 12.05.2025 Production problem Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 12.05.2025 Other Ciclopirox-Olamin Change notification 12.05.2025 Other Mometasone furoate (Ph.Eur.) Change notification 12.05.2025 Other - 2025.05.12
Active ingredients Message type Date of the last message Type of reason Atorvastatin calcium trihydrate (Ph.Eur.) Initial notification 09.05.2025 Other Clarithromycin Initial notification 09.05.2025 Production problem Tacrolimus Initial notification 09.05.2025 Other Trandolapril; verapamil hydrochloride Change notification 09.05.2025 Production problem Trandolapril; verapamil hydrochloride Change notification 09.05.2025 Other Tacrolimus monohydrate Change notification 09.05.2025 Production problem Sufentanil citrate Change notification 08.05.2025 Production problem Quetiapine fumarate (Ph.Eur.) Change notification 08.05.2025 Production problem Methylphenidate hydrochloride Change notification 08.05.2025 Other Mesalazine Initial notification 08.05.2025 Other Triptorelin acetate (1:x) ((with information on acetic acid content)) Initial notification 08.05.2025 Production problem Cabergoline Initial notification 07.05.2025 Other Fluorouracil Change notification 07.05.2025 Other Vincristine sulfate Initial notification 07.05.2025 Production problem Levetiracetam Change notification 07.05.2025 Production problem Atenolol; chlorthalidone Change notification 07.05.2025 Other Caspofungin diacetate Change notification 07.05.2025 Other Clobetasol propionate (Ph.Eur.) Initial notification 07.05.2025 Other Mometasone furoate (Ph.Eur.) Change notification 07.05.2025 Other Epirubicin hydrochloride Initial notification 07.05.2025 Production problem Doxorubicin hydrochloride Change notification 07.05.2025 Production problem Galantamine hydrobromide Change notification 06.05.2025 Production problem Atomoxetine hydrochloride Change notification 06.05.2025 Production problem Ethambutol dihydrochloride Initial notification 06.05.2025 Other Cinacalcethydrochloride Initial notification 06.05.2025 Other Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y) Initial notification 06.05.2025 Other Buprenorphine Change notification 06.05.2025 Other Azithromycin dihydrate Change notification 06.05.2025 Other Buprenorphine Change notification 06.05.2025 Other Articaine hydrochloride; epinephrine hydrogen tartrate/adrenaline hydrogen tartrate Change notification 05.05.2025 Production problem Mepivacaine hydrochloride Change notification 05.05.2025 Production problem Quetiapine fumarate (Ph.Eur.) Change notification 05.05.2025 Other Ciclosporin Initial notification 05.05.2025 Other Rotigotine Change notification 05.05.2025 Production problem Domperidone Change notification 05.05.2025 Production problem Melperone hydrochloride Change notification 05.05.2025 Production problem Gentamicin sulfate Change notification 05.05.2025 Production problem Vancomycin hydrochloride Change notification 05.05.2025 Other Ribavirin Initial notification 05.05.2025 Other Methylphenidate hydrochloride Change notification 05.05.2025 Other Indapamide Initial notification 05.05.2025 Production problem Benperidol Change notification 05.05.2025 Production problem Flupentixol decanoate Change notification 05.05.2025 Production problem Deferasirox Initial notification 05.05.2025 Other