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年9月1日