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年9月8日