- 2025.09.22
Paliperidone palmitate Initial report 19.09.2025 Other XEPLION 25 mg depot injection suspension – OP1ml Beclomethasone dipropionate (Ph.Eur.) Change notification 19.09.2025 Other Beclorhinol aquosum 50 micrograms Quetiapine fumarate (Ph.Eur.) Initial report 19.09.2025 Other Seroquel Prolong 200 mg prolonged-release tablets Olanzapine embonate monohydrate Change notification 19.09.2025 Production problem ZYPADHERA 405 mg powder and solvent for the preparation of a prolonged-release suspension for injection – OP(931mg+3ml) Paliperidone palmitate Change notification 19.09.2025 Production problem Paliperidone Advanz Pharma 50 mg prolonged-action injection suspension in a pre-filled syringe Paliperidone palmitate Change notification 19.09.2025 Production problem Paliperidone Advanz Pharma 25 mg prolonged-release injection suspension in a pre-filled syringe Naloxegol oxalate Change notification 19.09.2025 Other Moventig 25 mg film-coated tablets – OP100(100×1) Naloxone hydrochloride dihydrate; oxycodone hydrochloride monohydrate Initial report 19.09.2025 Production problem Targin 60 mg/30 mg prolonged-release tablets Oxycodone hydrochloride Change notification 18.09.2025 Other OXYGESIC 10 mg Ciprofloxacin hydrochloride monohydrate Change notification 18.09.2025 Other CIPRO BASICS 250 mg film-coated tablets Ciprofloxacin hydrochloride monohydrate Initial report 18.09.2025 Other CIPRO BASICS 750 mg film-coated tablets Flecainide acetate Change notification 18.09.2025 Other Tambocor Tobramycin Change notification 18.09.2025 Production problem TOBI Podhaler 28 mg hard capsules with powder for inhalation – OP224(4×56) Azithromycin dihydrate Change notification 18.09.2025 Other Azithromycin AL 250 mg film-coated tablets Clonidine hydrochloride Initial report 18.09.2025 Production problem Clonistada 0.15 mg tablets Ipratropium bromide (Ph.Eur.) Change notification 18.09.2025 Production problem Ipratropium Teva 250 micrograms/1 ml solution for nebulizer Galantamine hydrobromide Change notification 18.09.2025 Other Galantamine-ratiopharm 8 mg hard capsules, delayed release Rizatriptan benzoate Change notification 17.09.2025 Production problem Rizatriptan Glenmark 5 mg tablets Rizatriptan benzoate Change notification 17.09.2025 Production problem Rizatriptan Glenmark 5 mg orodispersible tablets Rizatriptan benzoate Change notification 17.09.2025 Production problem Rizatriptan Glenmark 10 mg orodispersible tablets Rizatriptan benzoate Change notification 17.09.2025 Production problem Rizatriptan Glenmark 10 mg tablets Quetiapine fumarate (Ph.Eur.) Change notification 17.09.2025 Production problem Quetiapine Glenmark 200 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Initial report 17.09.2025 Production problem Quetiapine Glenmark 300 mg prolonged-release tablets Mometasone furoate (Ph.Eur.) Change notification 17.09.2025 Production problem Mometasone Glenmark 1 mg/g ointment Linezolid Change notification 17.09.2025 Production problem Linezolid Glenmark 600 mg film-coated tablets Nitrendipine Initial report 17.09.2025 Other Nitrendipine AbZ 20 mg tablets Nitrendipine Initial report 17.09.2025 Other Nitrendipine AbZ 10 mg tablets Nitrendipine Initial report 17.09.2025 Other Nitrendipine-ratiopharm 20 mg tablets Nitrendipine Initial report 17.09.2025 Other Nitrendipine-ratiopharm 10 mg tablets Nitrendipine Initial report 17.09.2025 Other Nitrendipine AL 20 Nitrendipine Initial report 17.09.2025 Other Nitrendipine AL 10 Misoprostol Initial report 17.09.2025 Other Angusta 25 microgram tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 17.09.2025 Other Atorvastatin Aristo 60 mg film-coated tablets Trandolapril Change notification 17.09.2025 Other Udrik 0.5 mg Fluoxetine hydrochloride Change notification 16.09.2025 Other Fluoxetine Micro Labs 10 mg hard capsules Fluoxetine hydrochloride Change notification 16.09.2025 Other Fluoxetine Micro Labs 20 mg hard capsules Fluoxetine hydrochloride Change notification 16.09.2025 Other Fluoxetine Micro Labs 30 mg hard capsules Fluoxetine hydrochloride Change notification 16.09.2025 Other Fluoxetine Micro Labs 40 mg hard capsules Fluoxetine hydrochloride Change notification 16.09.2025 Other Fluoxetine Micro Labs 60 mg hard capsules Aprepitant Change notification 16.09.2025 Other Aprepitant AL 125 mg hard capsules Rifampicin sodium Initial report 16.09.2025 Production problem Eremfat IV 300 mg Trandolapril; verapamil hydrochloride Change notification 16.09.2025 Other Tarka 180 mg/2 mg modified-release tablets Sufentanil citrate Change notification 15.09.2025 Production problem Sufenta 50 micrograms/ml solution for injection Isosorbide mononitrate Change notification 15.09.2025 Production problem ISMN STADA 20 mg tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 15.09.2025 Production problem Atorvastatin STADA 80 mg film-coated tablets Aprepitant Change notification 15.09.2025 Production problem Aprepitant STADA 125 mg hard capsules Doxylamine hydrogen succinate Change notification 15.09.2025 Production problem Hoggar Night 25 mg orodispersible tablets Flucloxacillin sodium 1 H<2>O Change notification 15.09.2025 Production problem Staphylex 250 mg capsules - 2025.09.15
Active ingredients Message type Date of last message Type of reason AM designation Hydrated dihydralazine sulfate (Ph.Eur.) Initial report 12.09.2025 Production problem Nepresol Doxepin hydrochloride (Ph.Eur.) Change notification 12.09.2025 Production problem Doxepin 75 Holsten Prednisolone acetate Change notification 12.09.2025 Production problem Predni-Ophtal Gel Indapamide; Perindopril arginine Initial report 12.09.2025 Other Perindopril arginine/indapamide Viatris 5 mg/1.25 mg film-coated tablets Indapamide; Perindopril tert-butylamine Initial report 12.09.2025 Other Perindopril-dura plus 2 mg/0.625 mg tablets Amantadine hemisulfate Change notification 12.09.2025 Other PK-Merz Infusion Trandolapril Initial report 12.09.2025 Other Udrik 0.5 mg Rosuvastatin calcium (Ph.Eur.) Initial report 11.09.2025 Other Rosuvastatin Aurobindo 20 mg film-coated tablets Atomoxetine hydrochloride Initial report 11.09.2025 Other Atomoxetine PUREN 10 mg hard capsules Atomoxetine hydrochloride Initial report 11.09.2025 Production problem Atomoxetine PUREN 80 mg hard capsules Amlodipine besylate; telmisartan Initial report 11.09.2025 Production problem TWYNSTA 80 mg/10 mg tablets – OP98 Amlodipine besylate; telmisartan Initial report 11.09.2025 Production problem TWYNSTA 40 mg/5 mg tablets – OP98 Terazosin hydrochloride dihydrate Change notification 11.09.2025 Other Heitrin 2mg Terazosin hydrochloride dihydrate Change notification 11.09.2025 Other Heitrin 5mg Terazosin hydrochloride dihydrate Change notification 11.09.2025 Other Heitrin 1 mg Oxazepam Change notification 11.09.2025 Other Oxazepam AL 10 Paliperidone palmitate Change notification 11.09.2025 Other Paliperidone AL 25 mg Depot injection suspension in a pre-filled syringe Azithromycin dihydrate Change notification 11.09.2025 Other Azithromycin AL 250 mg film-coated tablets Hydromorphone hydrochloride Change notification 11.09.2025 Other Hydromorphone PAINBREAK 4 mg prolonged-release tablets Hydromorphone hydrochloride Change notification 11.09.2025 Other Hydromorphone PAINBREAK 8 mg prolonged-release tablets Dexketoprofen trometamol Change notification 10.09.2025 Production problem Sympal inject 50 mg solution for injection/infusion Adenosine Initial report 09.09.2025 Production problem Adenosine Altamedics 3 mg/ml solution for injection Imiquimod Initial report 09.09.2025 Production problem Aldara 5% cream – OP24 Atorvastatin calcium trihydrate (Ph.Eur.) Initial report 09.09.2025 Other Sortis 20 mg chewable tablets Verteporfin Change notification 09.09.2025 Other Visudyne 15 mg powder for solution for infusion – OP1 Clonidine hydrochloride Initial report 09.09.2025 Other Clonidine-ratiopharm 300 Clonidine hydrochloride Initial report 09.09.2025 Other Clonidine-ratiopharm 150 Clonidine hydrochloride Initial report 09.09.2025 Other Clonidine-ratiopharm 75 Methylphenidate hydrochloride Change notification 09.09.2025 Other Methylphenidate-ratiopharm 40 mg hard capsules with modified release Methylphenidate hydrochloride Change notification 09.09.2025 Other Methylphenidate-ratiopharm 20 mg hard capsules with modified release Methylphenidate hydrochloride Initial report 09.09.2025 Other Methylphenidate-ratiopharm 30 mg hard capsules with modified release Methylphenidate hydrochloride Initial report 09.09.2025 Other Methylphenidate-ratiopharm 10 mg modified-release hard capsules Duloxetine Initial report 09.09.2025 Other Duloxetine Mylan 30 mg gastro-resistant hard capsules – OP100(Fl) Duloxetine Initial report 09.09.2025 Other Duloxetine Mylan 60 mg gastro-resistant hard capsules – OP100(Fl) Procaine hydrochloride Change notification 09.09.2025 Other Procaine 2% JENAPHARM Procaine hydrochloride Change notification 09.09.2025 Other Procaine 1% JENAPHARM Pramipexole dihydrochloride monohydrate Change notification 08.09.2025 Other Pramipexole – 1 A Pharma 0.52 mg prolonged-release tablets Sodium mycophenolate Change notification 08.09.2025 Other Mycophenolic acid HEXAL 360 mg gastro-resistant tablets Atomoxetine hydrochloride Change notification 08.09.2025 Production problem Atomoxetine beta 18 mg hard capsules Atomoxetine hydrochloride Change notification 08.09.2025 Production problem Atomoxetine beta 100 mg hard capsules Naloxone hydrochloride dihydrate; oxycodone hydrochloride (Ph.Eur.) Initial report 08.09.2025 Production problem Oxycodone/naloxone Krugmann 40 mg/20 mg prolonged-release tablets Naloxone hydrochloride dihydrate; oxycodone hydrochloride (Ph.Eur.) Initial report 08.09.2025 Production problem Oxycodone / Naloxone Krugmann 20 mg/10 mg prolonged-release tablets Oxycodone hydrochloride (Ph.Eur.) Change notification 08.09.2025 Production problem Oxygesic 5 mg Rosuvastatin Hemicalcium Change notification 08.09.2025 Other ROSUVASTATIN-ELPEN 40 mg film-coated tablets Rosuvastatin Hemicalcium Change notification 08.09.2025 Other ROSUVASTATIN-ELPEN 20 mg film-coated tablets Rosuvastatin Hemicalcium Change notification 08.09.2025 Other ROSUVASTATIN-ELPEN 10 mg film-coated tablets Rosuvastatin Hemicalcium Change notification 08.09.2025 Other ROSUVASTATIN-ELPEN 5 mg film-coated tablets Hydromorphone hydrochloride Initial report 08.09.2025 Production problem Palladon inject 20 mg/ml solution for injection/infusion Hydromorphone hydrochloride Initial report 08.09.2025 Production problem Palladon 2.6 mg hard capsules Oxycodone hydrochloride (Ph.Eur.) Change notification 08.09.2025 Other Oxygesic 5 mg Oxycodone hydrochloride Change notification 08.09.2025 Other OXYGESIC 10 mg Sugammadex sodium Change notification 08.09.2025 Production problem Sugammadex Amomed - 2025.09.08
Active ingredients Message type Date of last message Type of reason AM designation Amantadine hemisulfate Change notification 05.09.2025 Other PK-Merz Infusion Sodium (methylprednisolone-21-succinate) Change notification 05.09.2025 Other Urbason soluble forte 1000 mg Ipratropium bromide (Ph.Eur.); salbutamol sulfate Change notification 05.09.2025 Production problem COMBIPRASAL 0.5 mg / 2.5 mg solution for nebulizer Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y) Change notification 05.09.2025 Other Ferrlecit 40 mg Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y) Change notification 05.09.2025 Other Ferrlecit 62.5 mg Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 05.09.2025 Other Atorvastatin Micro Labs 10 mg film-coated tablets Esomeprazole hemimagnesium Change notification 04.09.2025 Production problem ESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsules Carbamazepine Initial report 04.09.2025 Production problem Tegretal 400 mg retard Olanzapine embonate monohydrate Change notification 04.09.2025 Production problem ZYPADHERA 300 mg powder and solvent for the preparation of a depot injection suspension – OP(690mg+3ml) Olanzapine Change notification 04.09.2025 Production problem Zyprexa 7.5 mg coated tablets – OP70(blister) Olanzapine Initial report 04.09.2025 Production problem ZYPREXA Olanzapine embonate monohydrate Change notification 04.09.2025 Production problem ZYPADHERA 405 mg powder and solvent for the preparation of a depot injection suspension – OP(931mg+3ml) Human insulin (with manufacturing information) Initial report 04.09.2025 Other Huminsulin Basal (NPH) for Pen 3 ml 100 IU/ml injection suspension in cartridge Betamethasone dipropionate (Ph.Eur.); gentamicin sulfate Initial report 04.09.2025 Other Diprogenta cream Methylphenidate hydrochloride Initial report 04.09.2025 Other Methylphenidate AL 36 mg prolonged-release tablets Paliperidone palmitate Change notification 04.09.2025 Other Paliperidone AL 50 mg depot injection suspension in a pre-filled syringe Insulin lispro Initial report 03.09.2025 Other Liprolog Mix50 100 /ml KwikPen injection suspension – OP[2x(5x3ml)] Human insulin (with manufacturing information) Initial report 03.09.2025 Other Huminsulin Basal (NPH) KwikPen 100 IU/ml injection suspension Fluorouracil Change notification 03.09.2025 Other Fluorouracil PhaRes 50 mg/ml solution for injection Phenytoin sodium Change notification 03.09.2025 Production problem Phenhydan Injection solution Methyl (5-amino-4-oxopentanoate) hydrochloride Change notification 03.09.2025 Other Metvix 160 mg/g cream Monosodium alendronate Change notification 03.09.2025 Other ALENDRONIC ACID BASICS once weekly 70 mg tablets Pramipexole dihydrochloride monohydrate Change notification 03.09.2025 Other Pramipexole-ratiopharm 0.26 mg prolonged-release tablets Dexamethasone; gentamicin sulfate Initial report 03.09.2025 Production problem Dexa-Gentamicin Gentamicin sulfate Change notification 03.09.2025 Production problem Gentamicin POS Ezetimibe; simvastatin Initial report 02.09.2025 Production problem EZETIMIB/SIMVA BASICS 10 mg/80 mg tablets Ezetimibe; simvastatin Initial report 02.09.2025 Production problem EZETIMIBE/SIMVA BASICS 10 mg/40 mg tablets Ezetimibe; simvastatin Initial report 02.09.2025 Production problem EZETIMIBE/SIMVA BASICS 10 mg/20 mg tablets Ezetimibe; simvastatin Initial report 02.09.2025 Production problem EZETIMIBE/SIMVA BASICS 10 mg/10 mg tablets Chorionic gonadotropin Initial report 02.09.2025 Other BREVACTID 5000 IU powder and solvent for solution for injection Oxycodone hydrochloride (Ph.Eur.) Change notification 02.09.2025 Other Oxycodone hydrochloride – 1 A Pharma 10 mg prolonged-release tablets Methylphenidate hydrochloride Change notification 02.09.2025 Other Methylphenidate AL 27 mg prolonged-release tablets Methylphenidate hydrochloride Change notification 02.09.2025 Other Methylphenidate AL 18 mg prolonged-release tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 02.09.2025 Other Atorvastatin PUREN 40 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 02.09.2025 Other Atorvastatin PUREN 10 mg film-coated tablets Urapidil Change notification 02.09.2025 Other Urapidil PUREN 90 mg prolonged-release capsules Nevirapine Change notification 02.09.2025 Other Nevirapine Aurobindo 400 mg prolonged-release tablets Risperidone Change notification 02.09.2025 Other Risperidone Aurobindo 1 mg film-coated tablets Risperidone Change notification 02.09.2025 Other Risperidone PUREN 1 mg film-coated tablets Pregabalin Change notification 02.09.2025 Other Pregabalin Aurobindo 25 mg hard capsules Rivastigmine hydrogen tartrate Change notification 02.09.2025 Production problem Rivastigmine Aurobindo 6 mg hard capsules Timolol maleate Initial report 01.09.2025 Production problem Tim-Ophtal 0.5% sine Trandolapril; verapamil hydrochloride Change notification 01.09.2025 Other Tarka 180 mg/2 mg modified-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 01.09.2025 Other Seroquel Prolong 50 mg prolonged-release tablets - 2025.09.01
Active ingredients AM designation Message type Date of last message Type of reason Epinephrine hydrochloride Suprarenin ampoules Change notification 29.08.2025 Production problem Norepinephrine hydrochloride/noradrenaline hydrochloride Arterenol 1 ml Change notification 29.08.2025 Production problem Isophane insulin suspension for injection (Ph.Eur.) Protaphane FlexPen 100 IU/ml injection suspension in injector – OP (10x3ml) Initial report 29.08.2025 Other Sodium (methylprednisolone-21-succinate) Urbason solubile forte 1000 mg Change notification 29.08.2025 Other Doxepin hydrochloride (Ph.Eur.) Doxepin 25 Holsten Change notification 29.08.2025 Production problem Olanzapine embonate monohydrate ZYPADHERA 405 mg powder and solvent for the preparation of a depot injection suspension – OP(931mg+3ml) Change notification 29.08.2025 Production problem Olanzapine embonate monohydrate ZYPADHERA 300 mg powder and solvent for the preparation of a prolonged-release injection suspension – OP(690mg+3ml) Change notification 29.08.2025 Production problem Terazosin hydrochloride dihydrate Tera TAD 2mg Change notification 28.08.2025 Other Terazosin hydrochloride dihydrate Tera TAD 5mg Change notification 28.08.2025 Other Terazosin hydrochloride dihydrate Tera TAD 10mg Change notification 28.08.2025 Other Oxcarbazepine Oxcarbazepine – 1 A Pharma 60 mg/ml oral suspension Initial report 28.08.2025 Other Quetiapine fumarate (Ph.Eur.) Quetiapine-Hormosan 200 mg prolonged-release tablets Change notification 28.08.2025 Other Quetiapine fumarate (Ph.Eur.) Quetiapine Hormosan 300 mg prolonged-release tablets Change notification 28.08.2025 Other Quetiapine fumarate (Ph.Eur.) Quetiapine-Hormosan 400 mg prolonged-release tablets Change notification 28.08.2025 Other Medium-chain triglycerides; omega-3 acid triglycerides (with information on origin and/or composition); refined soybean oil (Ph.Eur.) Lipidem Emulsion for infusion Initial report 28.08.2025 Production problem Quetiapine fumarate (Ph.Eur.) Seroquel Prolong 150 mg prolonged-release tablets Initial report 28.08.2025 Other Calcitriol Calcitriol KyraMed 0.25 micrograms Initial report 28.08.2025 Other Quetiapine fumarate (Ph.Eur.) Quetiapine – 1 A Pharma 600 mg prolonged-release tablets Change notification 28.08.2025 Production problem Quetiapine fumarate (Ph.Eur.) Quetiapine – 1 A Pharma 50 mg prolonged-release tablets Change notification 28.08.2025 Production problem Quetiapine fumarate (Ph.Eur.) Quetiapine – 1 A Pharma 400 mg prolonged-release tablets Change notification 28.08.2025 Production problem Quetiapine fumarate (Ph.Eur.) Quetiapine – 1 A Pharma 300 mg prolonged-release tablets Change notification 28.08.2025 Production problem Quetiapine fumarate (Ph.Eur.) Quetiapine – 1 A Pharma 200 mg prolonged-release tablets Change notification 28.08.2025 Production problem Quetiapine fumarate (Ph.Eur.) Quetiapine – 1 A Pharma 150 mg prolonged-release tablets Change notification 28.08.2025 Production problem Sevelamer Renagel 800 mg film-coated tablets – OP(1×180) Initial report 28.08.2025 Other Paliperidone palmitate Paliperidone AL 25 mg Depot injection suspension in a pre-filled syringe Change notification 28.08.2025 Other Paliperidone palmitate Paliperidone AL 150 mg depot injection suspension in a pre-filled syringe Change notification 28.08.2025 Other Duloxetine hydrochloride Duloxetine AL 120 mg gastro-resistant hard capsules Change notification 28.08.2025 Other Aprepitant Aprepitant STADA 80 mg hard capsules Change notification 28.08.2025 Production problem Methylphenidate hydrochloride Methylphenidate AL 18 mg prolonged-release tablets Change notification 28.08.2025 Other Ipratropium bromide (Ph.Eur.) Ipratropium Teva 250 micrograms/1 ml solution for nebulizer Change notification 28.08.2025 Production problem Oxazepam Oxa-CT 10 mg tablets Change notification 28.08.2025 Other Ribavirin Ribavirin-ratiopharm 200 mg film-coated tablets Change notification 28.08.2025 Other Ribavirin Ribavirin-ratiopharm 400 mg film-coated tablets Change notification 28.08.2025 Other Carbamazepine Carbamazepine-ratiopharm 200 mg prolonged-release tablets Change notification 28.08.2025 Other Oxazepam Oxazepam-ratiopharm 10 mg tablets Change notification 28.08.2025 Other Pramipexole dihydrochloride monohydrate Pramipexole-ratiopharm 0.52 mg prolonged-release tablets Change notification 28.08.2025 Other Rosuvastatin Hemicalcium Rosuvastatin Aristo 5 mg film-coated tablets Change notification 27.08.2025 Production problem Rosuvastatin Hemicalcium Rosuvastatin Aristo 20 mg film-coated tablets Change notification 27.08.2025 Other Rosuvastatin Hemicalcium Rosuvastatin Aristo 10 mg film-coated tablets Change notification 27.08.2025 Other Melperone hydrochloride Melperone Aristo 50 mg film-coated tablets Change notification 27.08.2025 Other Melperone hydrochloride Melperon Aristo 100 mg film-coated tablets Change notification 27.08.2025 Production problem Oxazepam Oxazepam AL 10 Change notification 27.08.2025 Other Atorvastatin calcium trihydrate (Ph.Eur.) Atorvastatin Aristo 60 mg film-coated tablets Change notification 27.08.2025 Other Codeine phosphate hemihydrate; caffeine; paracetamol Azur compositum Change notification 27.08.2025 Other Esomeprazole hemimagnesium ESOMEPRAZOLE BASICS 40 mg gastro-resistant hard capsules Change notification 27.08.2025 Production problem Esomeprazole hemimagnesium ESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsules Change notification 27.08.2025 Production problem Clarithromycin CLARITHROMYCIN BASICS 250 mg/5 ml granules for oral suspension Change notification 27.08.2025 Production problem Chlortalidone Chlortalidone HEXAL 50 mg tablets Change notification 27.08.2025 Other Chlortalidone Chlortalidone HEXAL 25 mg tablets Change notification 27.08.2025 Other Pramipexole dihydrochloride monohydrate Pramipexole Mylan 3.15 mg prolonged-release tablets Initial report 27.08.2025 Other Amikacin sulfate Amikacin B. Braun 5 mg/ml solution for infusion Initial report 27.08.2025 Production problem Amikacin sulfate Amikacin B. Braun 2.5 mg/ml solution for infusion Initial report 27.08.2025 Production problem Calcitriol Renatriol 0.25 µg Initial report 26.08.2025 Other Anastrozole Anastrozole Denk 1 mg film-coated tablets Initial report 26.08.2025 Other Clopidogrel besylate Clopidogrel Denk 75 mg film-coated tablets Change notification 26.08.2025 Other Ketotifen fumarate Ketotifen STADA 1 mg hard capsules Change notification 26.08.2025 Production problem Midodrine hydrochloride Gutron tablets Change notification 26.08.2025 Other Clomethiazole hemidisilate Distraneurin mixture Initial report 25.08.2025 Other Pramipexole dihydrochloride monohydrate Pramipexole – 1 A Pharma 0.26 mg prolonged-release tablets Change notification 25.08.2025 Other Sodium mycophenolate Mycophenolic acid HEXAL 360 mg gastro-resistant tablets Change notification 25.08.2025 Other Quetiapine fumarate (Ph.Eur.) Quetiapine HEXAL 50 mg prolonged-release tablets Change notification 25.08.2025 Production problem Quetiapine fumarate (Ph.Eur.) Quetiapine HEXAL 400 mg prolonged-release tablets Change notification 25.08.2025 Production problem Quetiapine fumarate (Ph.Eur.) Quetiapine HEXAL 300 mg prolonged-release tablets Change notification 25.08.2025 Production problem Quetiapine fumarate (Ph.Eur.) Quetiapine HEXAL 200 mg prolonged-release tablets Change notification 25.08.2025 Production problem Quetiapine fumarate (Ph.Eur.) Quetiapine HEXAL 150 mg prolonged-release tablets Change notification 25.08.2025 Production problem Methylphenidate hydrochloride Methylphenidate hydrochloride – 1 A Pharma 36 mg prolonged-release tablets Change notification 25.08.2025 Other Methylphenidate hydrochloride Methylphenidate hydrochloride HEXAL 36 mg prolonged-release tablets Change notification 25.08.2025 Other Insulin glargine Semglee 100 units/ml solution for injection in pre-filled pen – OP(5x3ml) Change notification 25.08.2025 Other Levetiracetam Levetiracetam – 1 A Pharma 1500 mg film-coated tablets Change notification 25.08.2025 Other - 2025.08.25
Active ingredients Report type Date of last message Type of reason AM designation Midodrine hydrochloride Change notification 22.08.2025 Other Gutron tablets Beclometasone dipropionate (Ph.Eur.) Initial 21.08.2025 Other Beclorhinol aquosum 50 micrograms Calcium acetate hydrate ((with information on water content (1:x))) Change notification 21.08.2025 Production problem Renacet 950 mg Gabapentin Initial 21.08.2025 Other Gabapentin Holsten 300 mg hard capsules Gabapentin Initial 21.08.2025 Production problem Gabapentin Holsten 600 mg film-coated tablets Carbamazepine Change notification 21.08.2025 Other Carbadura 400 mg retard Insulin aspart Change notification 21.08.2025 Other NovoRapid PumpCart 100 E/ml solution for injection in cartridge – OP[5x(5×1.6ml)] Methylphenidate hydrochloride Initial 21.08.2025 Other Methylphenidate hydrochloride – Neuraxpharm 18 mg prolonged-release tablets Human insulin (with manufacturing details); isophane insulin suspension for injection (Ph.Eur.) Change notification 21.08.2025 Other Actraphane 30 FlexPen 100 IU/ml injection suspension in injector – OP(10x3ml) Biperiden hydrochloride Change notification 21.08.2025 Production problem Biperiden-neuraxpharm 4 mg Biperiden hydrochloride Change notification 21.08.2025 Production problem Biperiden-neuraxpharm 2 mg Trimipramine mesylate Change notification 20.08.2025 Other Trimipramine – 1 A Pharma 40 mg/ml oral drops, solution Hydromorphone hydrochloride Change notification 20.08.2025 Other Hydromorphone-HEXAL 2.6 mg hard capsules Zoledronic acid monohydrate Change notification 20.08.2025 Production problem Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion – OP[4x(4x5ml)] Zoledronic acid monohydrate Change notification 20.08.2025 Production problem Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion – OP5ml Methylphenidate hydrochloride Change notification 19.08.2025 Other Methylphenidate AL 18 mg prolonged-release tablets Paliperidone palmitate Change notification 19.08.2025 Other Paliperidone AL 150 mg depot injection suspension in a pre-filled syringe Ketotifen fumarate Initial 19.08.2025 Production problem Ketotifen STADA 1 mg hard capsules Quetiapine fumarate (Ph.Eur.) Change notification 19.08.2025 Other Seroquel Prolong 50 mg prolonged-release tablets Methylphenidate hydrochloride Change notification 19.08.2025 Other METHYLPHENI TAD 10 mg tablets Vincristine sulfate Change notification 19.08.2025 Production problem Vincristine sulfate-TEVA 1 mg/ml injection solution Phenytoin sodium Initial 19.08.2025 Production problem Phenhydan injection solution Quetiapine fumarate (Ph.Eur.) Change notification 19.08.2025 Other Seroquel Prolong 300 mg prolonged-release tablets Phenylephrine hydrochloride Initial 19.08.2025 Production problem Neosynephrine POS 5% Olanzapine embonate monohydrate Change notification 18.08.2025 Production problem ZYPADHERA 210 mg powder and solvent for the preparation of a depot injection suspension – OP(483mg+3ml) Olanzapine Change notification 18.08.2025 Production problem Zyprexa 7.5 mg coated tablets – OP70 (blister pack) Olanzapine embonate monohydrate Change notification 18.08.2025 Production problem ZYPADHERA 300 mg powder and solvent for the preparation of a depot injection suspension – OP(690mg+3ml) Norepinephrine hydrochloride/noradrenaline hydrochloride Change notification 18.08.2025 Production problem Arterenol 1 ml Baclofen Initial 18.08.2025 Other Lioresal Intrathecal 0.05 mg/1 ml solution for injection Primidone Initial 18.08.2025 Production problem Mylepsinum - 2025.08.18
Active ingredients Report type Date of last message Type of reason AM designation Sertraline hydrochloride Change notification 15.08.2025 Other Sertraline TAD 100 mg film-coated tablets Sertraline hydrochloride Change notification 15.08.2025 Other Sertraline TAD 50 mg film-coated tablets Phenoxybenzamine hydrochloride Change notification 15.08.2025 Other Dibenzyran 10 Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 15.08.2025 Other Atorvastatin Micro Labs 20 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 15.08.2025 Other Atorvastatin Micro Labs 40 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 15.08.2025 Other Atorvastatin Micro Labs 80 mg film-coated tablets Rifampicin Change notification 15.08.2025 Production problem EREMFAT 450 mg Acetylcholine chloride Change notification 15.08.2025 Production problem Miochol-E powder and solvent for the preparation of an instillation solution for intraocular use Azithromycin dihydrate Change notification 15.08.2025 Other Azithromycin AL 250 mg film-coated tablets Galantamine hydrobromide Change notification 14.08.2025 Production problem Galantamine Heumann 24 mg hard capsules, delayed release Quetiapine fumarate (Ph.Eur.) Change notification 14.08.2025 Production problem Quetiapine Heumann retard 200 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 14.08.2025 Production problem Quetiapine Heumann retard 150 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 14.08.2025 Production problem Quetiapine Heumann retard 50 mg prolonged-release tablets Sodium diphosphate decahydrate for the manufacture of radioactive medicinal products Initial 14.08.2025 Other Technescan PYP Tobramycin Change notification 14.08.2025 Production problem TOBI Podhaler 28 mg hard capsules with powder for inhalation – OP224(4×56) Alprazolam Initial 14.08.2025 Other Alprazolam-ratiopharm 1.0 mg tablets Emtricitabine; tenofovir disoproxil maleate Change notification 14.08.2025 Other Emtricitabine/tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets – OP30(Fl) Naloxegol oxalate Initial 13.08.2025 Other Moventig 25 mg film-coated tablets – OP100(100×1) Isoniazid Change notification 13.08.2025 Other Isozid 200 mg Methyl (5-amino-4-oxopentanoate) hydrochloride Change notification 12.08.2025 Other Metvix 160 mg/g cream Olanzapine Initial 12.08.2025 Production problem Olanzapine Glenmark 5 mg tablets – OP70 Olanzapine Initial 12.08.2025 Production problem Olanzapine Glenmark 2.5 mg tablets – OP70 Olanzapine Initial 12.08.2025 Production problem Olanzapine Glenmark 2.5 mg tablets – OP56 Olanzapine Initial 12.08.2025 Production problem Olanzapine Glenmark 10 mg tablets – OP70 Olanzapine Initial 12.08.2025 Production problem Olanzapine Glenmark 10 mg tablets – OP56 Trazodone hydrochloride Change notification 12.08.2025 Production problem Trazodone Glenmark 100 mg tablets Rizatriptan benzoate Change notification 12.08.2025 Production problem Rizatriptan Glenmark 10 mg tablets Rizatriptan benzoate Change notification 12.08.2025 Production problem Rizatriptan Glenmark 10 mg orodispersible tablets Rizatriptan benzoate Change notification 12.08.2025 Production problem Rizatriptan Glenmark 5 mg orodispersible tablets Rizatriptan benzoate Change notification 12.08.2025 Production problem Rizatriptan Glenmark 5 mg tablets Quetiapine fumarate (Ph.Eur.) Initial 12.08.2025 Production problem Quetiapine Glenmark 300 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 12.08.2025 Production problem Quetiapine Glenmark 400 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 12.08.2025 Production problem Quetiapine Glenmark 200 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 12.08.2025 Production problem Quetiapine Glenmark 150 mg prolonged-release tablets Mometasone furoate (Ph.Eur.) Change notification 12.08.2025 Production problem Mometasone Glenmark 1 mg/g ointment Linezolid Change notification 12.08.2025 Production problem Linezolid Glenmark 600 mg film-coated tablets Galantamine hydrobromide Change notification 12.08.2025 Production problem Galantamine Glenmark 24 mg hard capsules, delayed release Galantamine hydrobromide Change notification 12.08.2025 Production problem Galantamine Glenmark 8 mg hard capsules, delayed release Galantamine hydrobromide Change notification 12.08.2025 Production problem Galantamine Glenmark 16 mg hard capsules, delayed release Pirfenidone Initial 12.08.2025 Production problem Pirfenidone Accord 801 mg film-coated tablets Ezetimibe; Simvastatin Initial 12.08.2025 Production problem Ezetimibe/Simvastatin Glenmark 10 mg/20 mg tablets Alprazolam Initial 12.08.2025 Other Alprazolam – 1 A Pharma 1 mg tablets Alprazolam Initial 12.08.2025 Other Alprazolam – 1 A Pharma 0.5 mg tablets Gabapentin Initial 12.08.2025 Production problem Gabapentin Holsten 800 mg film-coated tablets Gabapentin Initial 12.08.2025 Other Gabapentin Holsten 100 mg hard capsules Doxepine hydrochloride (Ph.Eur.) Initial 12.08.2025 Other Doxepin 75 Holsten Zoledronic acid monohydrate Change notification 12.08.2025 Production problem Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion – OP5ml Rifampicin Initial 12.08.2025 Other EREMFAT 300 mg Vancomycin hydrochloride Initial 12.08.2025 Other Vancomycin “Lederle” 1000 mg Urapidil Change notification 12.08.2025 Other Urapidil PUREN 90 mg prolonged-release capsules Topiramate Change notification 12.08.2025 Production problem Topiramate PUREN 100 mg film-coated tablets Sitagliptin hydrochloride monohydrate Change notification 12.08.2025 Production problem Sitagliptin PUREN 50 mg film-coated tablets Sitagliptin hydrochloride monohydrate Change notification 12.08.2025 Production problem Sitagliptin Aurobindo 25 mg film-coated tablets Rizatriptan benzoate Change notification 12.08.2025 Production problem Rizatriptan PUREN 5 mg tablets Rizatriptan benzoate Change notification 12.08.2025 Other Rizatriptan PUREN 10 mg tablets Rizatriptan benzoate Change notification 12.08.2025 Other Rizatriptan Aurobindo 10 mg orodispersible tablets Risperidone Change notification 12.08.2025 Other Risperidone PUREN 1 mg film-coated tablets Risperidone Change notification 12.08.2025 Other Risperidone Aurobindo 1 mg film-coated tablets Docetaxel Change notification 12.08.2025 Other Docetaxel Aurobindo 20 mg/ml concentrate for solution for infusion Nevirapine Change notification 12.08.2025 Other Nevirapine Aurobindo 400 mg prolonged-release tablets Moxifloxacin hydrochloride (Ph.Eur.) (with information on water content (1:x)) Change notification 12.08.2025 Production problem Moxifloxacin Aurobindo 400 mg film-coated tablets Moxifloxacin hydrochloride (Ph.Eur.) (with information on water content (1:x)) Change notification 12.08.2025 Production problem Moxifloxacin PUREN 400 mg film-coated tablets Ibuprofen Change notification 12.08.2025 Other IBU-PUREN acute 400 mg film-coated tablets Oxycodone hydrochloride (Ph.Eur.) Change notification 11.08.2025 Other Oxygesic 5 mg Paliperidone palmitate Change notification 11.08.2025 Production problem Paliperidone Advanz Pharma 25 mg Depot injection suspension in a pre-filled syringe Paliperidone palmitate Change notification 11.08.2025 Production problem Paliperidone Advanz Pharma 50 mg depot injection suspension in a pre-filled syringe Hydromorphone hydrochloride Change notification 11.08.2025 Other Hydromorphone HEXAL 2.6 mg hard capsules Insulin aspart Initial 11.08.2025 Other NovoRapid PumpCart 100 E/ml injection solution in cartridge – OP[5x(5×1.6ml)] Chlortalidone Change notification 11.08.2025 Other Chlortalidone HEXAL 25 mg tablets Chlortalidone Change notification 11.08.2025 Other Chlortalidone HEXAL 50 mg tablets Sufentanil Initial 11.08.2025 Production problem Sufentanil-hameln 50 micrograms/ml injection/infusion solution Oxycodone hydrochloride (Ph.Eur.) Initial 11.08.2025 Other Oxycodone-HCl HEXAL 40 mg prolonged-release tablets Oxycodone hydrochloride (Ph.Eur.) Initial 11.08.2025 Other Oxycodone-HCl HEXAL 20 mg prolonged-release tablets Oxycodone hydrochloride (Ph.Eur.) Initial 11.08.2025 Other Oxycodone-HCl HEXAL 10 mg prolonged-release tablets Oxycodone hydrochloride (Ph.Eur.) Initial 11.08.2025 Other Oxycodone-HCl HEXAL 5 mg prolonged-release tablets Hydromorphone hydrochloride Change notification 11.08.2025 Other Hydromorphone HCl PUREN 4 mg hard capsules, delayed release Escitalopram oxalate Change notification 11.08.2025 Other Escitalopram Aurobindo 10 mg film-coated tablets Etoricoxib Change notification 11.08.2025 Other Etoricoxib PUREN 120 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 11.08.2025 Other Atorvastatin PUREN 40 mg film-coated tablets Gabapentin Change notification 11.08.2025 Other Gabapentin Aurobindo 400 mg hard capsules Prasugrel Change notification 11.08.2025 Production problem Prasugrel PUREN 5 mg film-coated tablets Lamotrigine Change notification 11.08.2025 Production problem Lamotrigine Aurobindo 50 mg tablets Ramipril Change notification 11.08.2025 Other Ramipril PUREN 5 mg tablets Pregabalin Change notification 11.08.2025 Other Pregabalin Aurobindo 25 mg hard capsules Pregabalin Change notification 11.08.2025 Other Pregabalin PUREN 100 mg hard capsules - 2025.08.11
Active ingredients Report type Date of last message Type of reason AM designation Pramipexole dihydrochloride monohydrate Change notification 10.08.2025 Other Pramipexole PUREN 0.18 mg tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 10.08.2025 Other Atorvastatin PUREN 10 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Change notification 10.08.2025 Other Atorvastatin PUREN 20 mg film-coated tablets Paliperidone palmitate Change notification 08.08.2025 Other Paliperidone AL 150 mg depot injection suspension in a pre-filled syringe Quetiapine fumarate (Ph.Eur.) Change notification 08.08.2025 Other Quetiapine-neuraxpharm 600 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 08.08.2025 Other Quetiapine-neuraxpharm 400 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 08.08.2025 Other Quetiapine-neuraxpharm 300 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 08.08.2025 Other Quetiapine-neuraxpharm 200 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 08.08.2025 Other Quetiapine-neuraxpharm 150 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 08.08.2025 Other Quetiapine-neuraxpharm 50 mg prolonged-release tablets Levomepromazine hydrochloride Initial report 08.08.2025 Other Levomepromazine-neuraxpharm 25 mg/ml solution for injection Phenobarbital Change notification 08.08.2025 Production problem Phenobarbital-neuraxpharm 100 mg Phenobarbital Change notification 08.08.2025 Production problem Phenobarbital-neuraxpharm 15 mg Methylphenidate hydrochloride Change notification 08.08.2025 Other Methylphenidate hydrochloride-neuraxpharm 27 mg prolonged-release tablets Haloperidol decanoate Change notification 08.08.2025 Production problem Haloperidol-neuraxpharm decanoate 100 mg/ml Haloperidol decanoate Change notification 08.08.2025 Production problem Haloperidol-neuraxpharm decanoate 50 mg/ml Galantamine hydrobromide Change notification 08.08.2025 Other Galantamine-neuraxpharm 24 mg hard capsules, delayed release Galantamine hydrobromide Change notification 08.08.2025 Other Galantamine-neuraxpharm 16 mg Hard capsules, delayed release Galantamine hydrobromide Change notification 08.08.2025 Other Galantamine-neuraxpharm 8 mg hard capsules, delayed release Atomoxetine hydrochloride Change notification 08.08.2025 Production problem Atomoxetine-neuraxpharm 100 mg hard capsules Atomoxetine hydrochloride Change notification 08.08.2025 Production problem Atomoxetine-neuraxpharm 80 mg hard capsules Atomoxetine hydrochloride Change notification 08.08.2025 Production problem Atomoxetine-neuraxpharm 40 mg hard capsules Atomoxetine hydrochloride Change notification 08.08.2025 Production problem Atomoxetine-neuraxpharm 25 mg hard capsules Atomoxetine hydrochloride Change notification 08.08.2025 Production problem Atomoxetine-neuraxpharm 18 mg hard capsules Atomoxetine hydrochloride Change notification 08.08.2025 Production problem Atomoxetine-neuraxpharm 10 mg hard capsules Atomoxetine hydrochloride Change notification 08.08.2025 Production problem Atomoxetine-neuraxpharm 60 mg hard capsules Nintedanib Initial report 07.08.2025 Other Ofev Von Willebrand factor Initial report 07.08.2025 Other WILLFACT 1000 IU Fusidic acid (Ph.Eur.) Change notification 07.08.2025 Production problem Fucithalmic 10 mg/g eye drops Calcium acetate hydrate ((with information on water content (1:x))) Change notification 07.08.2025 Production problem Renacet 950 mg Quetiapine fumarate (Ph.Eur.) Change notification 07.08.2025 Other Seroquel Prolong 50 mg prolonged-release tablets Fluoxetine hydrochloride Initial report 06.08.2025 Other Fluoxetine Micro Labs 60 mg hard capsules Fluoxetine hydrochloride Initial report 06.08.2025 Other Fluoxetine Micro Labs 40 mg hard capsules Fluoxetine hydrochloride Initial report 06.08.2025 Other Fluoxetine Micro Labs 30 mg hard capsules Fluoxetine hydrochloride Initial report 06.08.2025 Other Fluoxetine Micro Labs 20 mg hard capsules Fluoxetine hydrochloride Initial report 06.08.2025 Other Fluoxetine Micro Labs 10 mg hard capsules Trandolapril; verapamil hydrochloride Change notification 06.08.2025 Other Tarka 180 mg/ 2 mg modified-release tablets Brivaracetam Change notification 06.08.2025 Production problem Briviact 50 mg film-coated tablets – OP56 Quetiapine fumarate (Ph.Eur.) Change notification 06.08.2025 Other Seroquel Prolong 400 mg prolonged-release tablets Cinacalcet hydrochloride Change notification 06.08.2025 Other Cinacalcet-ratiopharm 30 mg film-coated tablets Atorvastatin hemicalcium Change notification 06.08.2025 Other Atorvastatin – 1A Pharma 80 mg film-coated tablets Atorvastatin calcium trihydrate (Ph.Eur.) Initial 06.08.2025 Other Atorvastatin-1A Pharma 20 mg film-coated tablets Pramipexole dihydrochloride monohydrate Change notification 05.08.2025 Production problem Pramipexole STADA 0.52 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 05.08.2025 Other Seroquel Prolong 300 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 05.08.2025 Other Seroquel Prolong 200 mg prolonged-release tablets Ipratropium bromide (Ph.Eur.); salbutamol sulfate Change notification 05.08.2025 Production problem COMBIPRASAL 0.5 mg / 2.5 mg solution for nebulizer Reproterol hydrochloride Change notification 05.08.2025 Production problem Bronchospasmin 10 ml solution for injection Tropicamide Change notification 05.08.2025 Production problem Mydriaticum Stulln UD Carbamazepine Initial 05.08.2025 Production problem Tegretal 200 mg retard Olanzapine embonate monohydrate Change notification 05.08.2025 Production problem ZYPADHERA 405 mg powder and solvent for the preparation of a depot injection suspension – OP (931 mg + 3 ml) Insulin aspart Change notification 05.08.2025 Other NovoMix 30 FlexPen 100 IU/ml injection suspension in pre-filled syringe – OP(10x3ml) Human insulin (with manufacturing details) Change notification 05.08.2025 Other Actrapid Penfill 100 IU/ml injection solution in cylinder ampoule – OP(10x3ml) Olanzapine embonate monohydrate Change notification 05.08.2025 Production problem ZYPADHERA 300 mg powder and solvent for the preparation of a depot injection suspension – OP(690mg+3ml) Isoniazid Initial 05.08.2025 Other Isozid 200 mg Prednisolone acetate Change notification 05.08.2025 Production problem Prednifluid 10 mg/ml eye drop suspension Atovaquone; proguanil hydrochloride Initial 04.08.2025 Other Malarone Junior film-coated tablets Mupirocin calcium (Ph.Eur.) Change notification 04.08.2025 Production problem Turixin Melperone hydrochloride Change notification 04.08.2025 Production problem Melperone Aristo 100 mg film-coated tablets Paliperidone palmitate Initial 04.08.2025 Other Paliperidone AL 50 mg depot injection suspension in a pre-filled syringe Iron (II) glycine sulfate complex Change notification 04.08.2025 Production problem Ferro sanol 30 mg/ml drops Clarithromycin Change notification 04.08.2025 Production problem CLARITHROMYCIN BASICS 250 mg/5 ml granules for oral suspension Esomeprazole hemimagnesium Change notification 04.08.2025 Production problem ESOMEPRAZOLE BASICS 40 mg gastro-resistant hard capsules Esomeprazole hemimagnesium Change notification 04.08.2025 Production problem ESOMEPRAZOLE BASICS 20 mg enteric-coated hard capsules Fluoxetine hydrochloride Change notification 04.08.2025 Production problem Fluoxetine Stada 20 mg tablets for oral suspension Gentamicin sulfate Change notification 04.08.2025 Production problem Gentamicin POS - 2025.08.04
- 2025.07.28
Active ingredients Report type Date of last message Type of reason AM designation Duloxetine hydrochloride Change notification 25.07.2025 Production problem Duloxetine PUREN 60 mg gastro-resistant hard capsules Chorionic gonadotropin Initial report 25.07.2025 Other BREVACTID 1500 I.E. Powder and solvent for solution for injection Human insulin (with manufacturing details) Initial report 25.07.2025 Other Berlinsulin H Normal 3 ml pen Betamethasone valerate (Ph.Eur.) Initial report 25.07.2025 Other Soderm crinale Azacitidine Initial report 25.07.2025 Other Azacitidine HEXAL 25 mg/ml powder for suspension for injection Minocycline hydrochloride dihydrate (Ph.Eur.) Initial report 25.07.2025 Production problem Skid 100 mg Minocycline hydrochloride dihydrate (Ph.Eur.) Initial report 25.07.2025 Production problem Skid 50 mg Galantamine hydrobromide Initial report 24.07.2025 Other Galanaxiro 24 mg hard capsules, delayed release Galantamine hydrobromide Initial report 24.07.2025 Other Galanaxiro 16 mg Hard capsules, delayed release Galantamine hydrobromide Initial report 24.07.2025 Other Galanaxiro 8 mg hard capsules, delayed release Lorazepam Change notification 24.07.2025 Other Tavor 1.0 mg Expidet Carbamazepine Change notification 24.07.2025 Other Carbamazepine AL 400 delayed release Methylphenidate hydrochloride Change notification 24.07.2025 Other Methylphenidate AL 18 mg prolonged-release tablets Tacrolimus monohydrate Change notification 24.07.2025 Other Tacrolimus AL 5 mg hard capsules, delayed release Tacrolimus monohydrate Change notification 24.07.2025 Other Tacrolimus AL 1 mg hard capsules, delayed release Tacrolimus monohydrate Change notification 24.07.2025 Other Tacrolimus AL 0.5 mg hard capsules, delayed release Tacrolimus monohydrate Change notification 24.07.2025 Other Tacrolimus AL 3 mg hard capsules, delayed release Duloxetine hydrochloride Change notification 24.07.2025 Other Duloxetine AL 120 mg gastro-resistant hard capsules Quetiapine fumarate (Ph.Eur.) Change notification 24.07.2025 Other Quetiapine AL 100 mg film-coated tablets Selegiline hydrochloride Initial report 24.07.2025 Other Selegiline AL 10 Selegiline hydrochloride Change notification 24.07.2025 Other Selegiline AL 5 Ribavirin Change notification 24.07.2025 Other Ribavirin-ratiopharm 400 mg film-coated tablets Insulin aspart Initial report 23.07.2025 Other NovoRapid 100 E/ml solution for injection in vial – OP[5x(1x10ml)] Paliperidone palmitate Change notification 23.07.2025 Other Paliperidone AL 25 mg depot injection suspension in a pre-filled syringe Azithromycin dihydrate Initial report 23.07.2025 Other Azithromycin AL 250 mg film-coated tablets Insulin lispro Initial report 22.07.2025 Other Liprolog 100 E/ml solution for injection in vial – OP[5x(1x10ml)] Trandolapril; verapamil hydrochloride Change notification 22.07.2025 Production problem Tarka 240 mg/2 mg tablets with modified release Zoledronic acid monohydrate Change notification 22.07.2025 Other Zole – 1 A Pharma 5 mg/100 ml infusion solution Trimipramine mesylate Change notification 22.07.2025 Other Trimipramine – 1 A Pharma 40 mg/ml oral drops, solution Pramipexole dihydrochloride monohydrate Change notification 22.07.2025 Other Pramipexole HEXAL 0.52 mg prolonged-release tablets Cyclophosphamide monohydrate Change notification 22.07.2025 Other Cyclophosphamide HEXAL 2000 mg Chlortalidone Change notification 22.07.2025 Other Chlortalidone HEXAL 50 mg tablets Semaglutide Change notification 22.07.2025 Other Ozempic 1 mg injection solution in a pre-filled pen – OP(3x3ml) Chlortalidone Change notification 22.07.2025 Other Chlortalidone HEXAL 25 mg tablets Atomoxetine hydrochloride Change notification 22.07.2025 Other Atomoxe – 1 A Pharma 80 mg hard capsules Atomoxetine hydrochloride Change notification 22.07.2025 Other Atomoxe – 1 A Pharma 60 mg hard capsules Atomoxetine hydrochloride Change notification 22.07.2025 Other Atomoxe – 1 A Pharma 40 mg hard capsules Atomoxetine hydrochloride Change notification 22.07.2025 Other Atomoxe – 1 A Pharma 25 mg hard capsules Atomoxetine hydrochloride Change notification 22.07.2025 Other Atomoxe – 1 A Pharma 18 mg hard capsules Atomoxetine hydrochloride Change notification 22.07.2025 Other Atomoxe – 1 A Pharma 100 mg hard capsules Atomoxetine hydrochloride Change notification 22.07.2025 Other Atomoxe – 1 A Pharma 10 mg hard capsules Urapidil Initial report 21.07.2025 Other Ebrantil 30 mg Lidocaine Initial report 21.07.2025 Production problem XYLOCAIN PUMP SPRAY Salbutamol sulfate Change notification 21.07.2025 Other Bronchospray novo Quetiapine fumarate (Ph.Eur.) Change notification 21.07.2025 Production problem Quetiapine Heumann retard 150 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 21.07.2025 Production problem Quetiapine Heumann retard 400 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 21.07.2025 Production problem Quetiapine Heumann retard 50 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 21.07.2025 Production problem Quetiapine Heumann retard 200 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 21.07.2025 Production problem Quetiapine Heumann retard 300 mg prolonged-release tablets Flunisolid hemihydrate Change notification 21.07.2025 Other Syntaris Framycetin sulfate (Ph.Eur.) Change notification 21.07.2025 Other Leukase N ointment Fluorouracil Change notification 21.07.2025 Other Fluorouracil Hikma 50 mg/ml solution for injection - 2025.07.21
Active ingredients Message type Date of last message Type of reason AM designation Olanzapine Initial report 18.07.2025 Production problem Zyprexa 7.5 mg coated tablets – OP70 (blister pack) Olanzapine embonate monohydrate Initial report 18.07.2025 Production problem ZYPADHERA 405 mg powder and solvent for the preparation of a depot injection suspension – OP(931mg+3ml) Olanzapine embonate monohydrate Change notification 18.07.2025 Production problem ZYPADHERA 300 mg powder and solvent for the preparation of a depot injection suspension – OP(690mg+3ml) Levetiracetam Initial report 18.07.2025 Other Levetiracetam UCB Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y) Change notification 18.07.2025 Other Ferrlecit 62.5 mg Zoledronic acid monohydrate Change notification 17.07.2025 Production problem Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion – OP[4x(4x5ml)] Zoledronic acid monohydrate Change notification 17.07.2025 Production problem Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion – OP5ml Paliperidone palmitate Change notification 17.07.2025 Other Paliperidone AL 25 mg depot injection suspension in a pre-filled syringe Tacrolimus monohydrate Change notification 17.07.2025 Other Tacrolimus AL 3 mg hard capsules, delayed release Epoetin beta Initial report 17.07.2025 Other NeoRecormon 4000 IU injection solution in pre-filled syringe – OP6 Duloxetine hydrochloride Change notification 17.07.2025 Production problem Duloxetine PUREN 40 mg gastro-resistant hard capsules Carbamazepine Initial report 17.07.2025 Other Carbadura 400 mg retard Tobramycin Initial report 17.07.2025 Production problem TOBI Podhaler 28 mg hard capsules with powder for inhalation – OP224(4×56) Etoposide Change notification 16.07.2025 Production problem Eto-Gry 20 mg/ml concentrate for solution for infusion Amantadine hemisulfate Change notification 16.07.2025 Other PK-Merz Infusion Clopidogrel besylate Initial report 16.07.2025 Other Clopidogrel Denk 75 mg film-coated tablets Amlodipine besylate; perindopril tert-butylamine Initial report 16.07.2025 Other Perindopril/amlodipine Denk 8 mg/10 mg tablets Amlodipine besylate; perindopril tert-butylamine Initial report 16.07.2025 Other Perindopril/amlodipine Denk 4 mg/10 mg tablets Amlodipine besylate; perindopril tert-butylamine Initial report 16.07.2025 Other Perindopril/amlodipine Denk 4 mg/5 mg tablets Methylphenidate hydrochloride Change notification 16.07.2025 Other Methylphenidate AL 18 mg prolonged-release tablets Methylphenidate hydrochloride Change notification 16.07.2025 Other Methylphenidate AL 27 mg prolonged-release tablets Initial report 16.07.2025 Production problem Teceos Methylphenidate hydrochloride Change notification 15.07.2025 Other METHYLPHENI TAD 20 mg tablets Methylphenidate hydrochloride Change notification 15.07.2025 Other METHYLPHENI TAD 5 mg tablets Methylphenidate hydrochloride Change notification 15.07.2025 Other METHYLPHENI TAD 10 mg tablets Semaglutide Change notification 15.07.2025 Other Ozempic 1 mg injection solution in a pre-filled pen – OP(3x3ml) Rifampicin Initial report 15.07.2025 Production problem EREMFAT 450 mg Methyldopa (Ph.Eur.) Initial report 15.07.2025 Other Dopegyt tablets Aprepitant Change notification 15.07.2025 Production problem Aprepitant beta 125 mg and 80 mg hard capsules Atomoxetine hydrochloride Change notification 15.07.2025 Production problem Atomoxetine beta 80 mg hard capsules Olanzapine embonate monohydrate Change notification 15.07.2025 Production problem ZYPADHERA 210 mg powder and solvent for the preparation of a depot injection suspension – OP(483mg+3ml) Cinacalcet hydrochloride Change notification 15.07.2025 Other Cinacalcet Mylan 60 mg film-coated tablets – OP(28×1) Trandolapril; verapamil hydrochloride Change notification 15.07.2025 Other Tarka 180 mg/ 2 mg modified-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 15.07.2025 Other Seroquel Prolong 50 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Change notification 15.07.2025 Other Seroquel Prolong 300 mg prolonged-release tablets Norepinephrine hydrochloride/noradrenaline hydrochloride Change notification 14.07.2025 Production problem Arterenol 1 ml Epinephrine hydrochloride Change notification 14.07.2025 Production problem Suprarenin ampoules Sodium iodide ((123)I) Initial report 14.07.2025 Other Sodium iodide (I 123) injection DRN 5375 Iobenguan ((123)I) Initial report 14.07.2025 Other MIBG (I123) injection DRN 5379 Quetiapine fumarate (Ph.Eur.) Initial report 14.07.2025 Production problem Quetiapine Accord 300 mg prolonged-release tablets Quetiapine fumarate (Ph.Eur.) Initial report 14.07.2025 Production problem Quetiapine Accord 50 mg prolonged-release tablets Midodrine hydrochloride Change notification 14.07.2025 Other Gutron tablets Insulin lispro Initial report 14.07.2025 Other Humalog Mix25 KwikPen 100 E/ml injection suspension – OP (5x3ml) Carbamazepine Initial report 14.07.2025 Other Carbamazepine-ratiopharm 400 mg prolonged-release tablets Carbamazepine Initial report 14.07.2025 Other Carbamazepine-ratiopharm 200 mg prolonged-release tablets Flucloxacillin sodium 1 H<2>O Change notification 14.07.2025 Production problem Staphylex 250 mg capsules Sodium (methylprednisolone-21-succinate) Change notification 14.07.2025 Other Urbason solubile forte 1000 mg