BfArMボトルネック・レポート(2025年8月25日~8月31日)

Active ingredientsAM designationMessage typeDate of last messageType of reason
Epinephrine hydrochlorideSuprarenin ampoulesChange notification29.08.2025Production problem
Norepinephrine hydrochloride/noradrenaline hydrochlorideArterenol 1 mlChange notification29.08.2025Production problem
Isophane insulin suspension for injection (Ph.Eur.)Protaphane FlexPen 100 IU/ml injection suspension in injector – OP (10x3ml)Initial report29.08.2025Other
Sodium (methylprednisolone-21-succinate)Urbason solubile forte 1000 mgChange notification29.08.2025Other
Doxepin hydrochloride (Ph.Eur.)Doxepin 25 HolstenChange notification29.08.2025Production problem
Olanzapine embonate monohydrateZYPADHERA 405 mg powder and solvent for the preparation of a depot injection suspension – OP(931mg+3ml)Change notification29.08.2025Production problem
Olanzapine embonate monohydrateZYPADHERA 300 mg powder and solvent for the preparation of a prolonged-release injection suspension – OP(690mg+3ml)Change notification29.08.2025Production problem
Terazosin hydrochloride dihydrateTera TAD 2mgChange notification28.08.2025Other
Terazosin hydrochloride dihydrateTera TAD 5mgChange notification28.08.2025Other
Terazosin hydrochloride dihydrateTera TAD 10mgChange notification28.08.2025Other
OxcarbazepineOxcarbazepine – 1 A Pharma 60 mg/ml oral suspensionInitial report28.08.2025Other
Quetiapine fumarate (Ph.Eur.)Quetiapine-Hormosan 200 mg prolonged-release tabletsChange notification28.08.2025Other
Quetiapine fumarate (Ph.Eur.)Quetiapine Hormosan 300 mg prolonged-release tabletsChange notification28.08.2025Other
Quetiapine fumarate (Ph.Eur.)Quetiapine-Hormosan 400 mg prolonged-release tabletsChange notification28.08.2025Other
Medium-chain triglycerides; omega-3 acid triglycerides (with information on origin and/or composition); refined soybean oil (Ph.Eur.)Lipidem Emulsion for infusionInitial report28.08.2025Production problem
Quetiapine fumarate (Ph.Eur.)Seroquel Prolong 150 mg prolonged-release tabletsInitial report28.08.2025Other
CalcitriolCalcitriol KyraMed 0.25 microgramsInitial report28.08.2025Other
Quetiapine fumarate (Ph.Eur.)Quetiapine – 1 A Pharma 600 mg prolonged-release tabletsChange notification28.08.2025Production problem
Quetiapine fumarate (Ph.Eur.)Quetiapine – 1 A Pharma 50 mg prolonged-release tabletsChange notification28.08.2025Production problem
Quetiapine fumarate (Ph.Eur.)Quetiapine – 1 A Pharma 400 mg prolonged-release tabletsChange notification28.08.2025Production problem
Quetiapine fumarate (Ph.Eur.)Quetiapine – 1 A Pharma 300 mg prolonged-release tabletsChange notification28.08.2025Production problem
Quetiapine fumarate (Ph.Eur.)Quetiapine – 1 A Pharma 200 mg prolonged-release tabletsChange notification28.08.2025Production problem
Quetiapine fumarate (Ph.Eur.)Quetiapine – 1 A Pharma 150 mg prolonged-release tabletsChange notification28.08.2025Production problem
SevelamerRenagel 800 mg film-coated tablets – OP(1×180)Initial report28.08.2025Other
Paliperidone palmitatePaliperidone AL 25 mg Depot injection suspension in a pre-filled syringeChange notification28.08.2025Other
Paliperidone palmitatePaliperidone AL 150 mg depot injection suspension in a pre-filled syringeChange notification28.08.2025Other
Duloxetine hydrochlorideDuloxetine AL 120 mg gastro-resistant hard capsulesChange notification28.08.2025Other
AprepitantAprepitant STADA 80 mg hard capsulesChange notification28.08.2025Production problem
Methylphenidate hydrochlorideMethylphenidate AL 18 mg prolonged-release tabletsChange notification28.08.2025Other
Ipratropium bromide (Ph.Eur.)Ipratropium Teva 250 micrograms/1 ml solution for nebulizerChange notification28.08.2025Production problem
OxazepamOxa-CT 10 mg tabletsChange notification28.08.2025Other
RibavirinRibavirin-ratiopharm 200 mg film-coated tabletsChange notification28.08.2025Other
RibavirinRibavirin-ratiopharm 400 mg film-coated tabletsChange notification28.08.2025Other
CarbamazepineCarbamazepine-ratiopharm 200 mg prolonged-release tabletsChange notification28.08.2025Other
OxazepamOxazepam-ratiopharm 10 mg tabletsChange notification28.08.2025Other
Pramipexole dihydrochloride monohydratePramipexole-ratiopharm 0.52 mg prolonged-release tabletsChange notification28.08.2025Other
Rosuvastatin HemicalciumRosuvastatin Aristo 5 mg film-coated tabletsChange notification27.08.2025Production problem
Rosuvastatin HemicalciumRosuvastatin Aristo 20 mg film-coated tabletsChange notification27.08.2025Other
Rosuvastatin HemicalciumRosuvastatin Aristo 10 mg film-coated tabletsChange notification27.08.2025Other
Melperone hydrochlorideMelperone Aristo 50 mg film-coated tabletsChange notification27.08.2025Other
Melperone hydrochlorideMelperon Aristo 100 mg film-coated tabletsChange notification27.08.2025Production problem
OxazepamOxazepam AL 10Change notification27.08.2025Other
Atorvastatin calcium trihydrate (Ph.Eur.)Atorvastatin Aristo 60 mg film-coated tabletsChange notification27.08.2025Other
Codeine phosphate hemihydrate; caffeine; paracetamolAzur compositumChange notification27.08.2025Other
Esomeprazole hemimagnesiumESOMEPRAZOLE BASICS 40 mg gastro-resistant hard capsulesChange notification27.08.2025Production problem
Esomeprazole hemimagnesiumESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsulesChange notification27.08.2025Production problem
ClarithromycinCLARITHROMYCIN BASICS 250 mg/5 ml granules for oral suspensionChange notification27.08.2025Production problem
ChlortalidoneChlortalidone HEXAL 50 mg tabletsChange notification27.08.2025Other
ChlortalidoneChlortalidone HEXAL 25 mg tabletsChange notification27.08.2025Other
Pramipexole dihydrochloride monohydratePramipexole Mylan 3.15 mg prolonged-release tabletsInitial report27.08.2025Other
Amikacin sulfateAmikacin B. Braun 5 mg/ml solution for infusionInitial report27.08.2025Production problem
Amikacin sulfateAmikacin B. Braun 2.5 mg/ml solution for infusionInitial report27.08.2025Production problem
CalcitriolRenatriol 0.25 µgInitial report26.08.2025Other
AnastrozoleAnastrozole Denk 1 mg film-coated tabletsInitial report26.08.2025Other
Clopidogrel besylateClopidogrel Denk 75 mg film-coated tabletsChange notification26.08.2025Other
Ketotifen fumarateKetotifen STADA 1 mg hard capsulesChange notification26.08.2025Production problem
Midodrine hydrochlorideGutron tabletsChange notification26.08.2025Other
Clomethiazole hemidisilateDistraneurin mixtureInitial report25.08.2025Other
Pramipexole dihydrochloride monohydratePramipexole – 1 A Pharma 0.26 mg prolonged-release tabletsChange notification25.08.2025Other
Sodium mycophenolateMycophenolic acid HEXAL 360 mg gastro-resistant tabletsChange notification25.08.2025Other
Quetiapine fumarate (Ph.Eur.)Quetiapine HEXAL 50 mg prolonged-release tabletsChange notification25.08.2025Production problem
Quetiapine fumarate (Ph.Eur.)Quetiapine HEXAL 400 mg prolonged-release tabletsChange notification25.08.2025Production problem
Quetiapine fumarate (Ph.Eur.)Quetiapine HEXAL 300 mg prolonged-release tabletsChange notification25.08.2025Production problem
Quetiapine fumarate (Ph.Eur.)Quetiapine HEXAL 200 mg prolonged-release tabletsChange notification25.08.2025Production problem
Quetiapine fumarate (Ph.Eur.)Quetiapine HEXAL 150 mg prolonged-release tabletsChange notification25.08.2025Production problem
Methylphenidate hydrochlorideMethylphenidate hydrochloride – 1 A Pharma 36 mg prolonged-release tabletsChange notification25.08.2025Other
Methylphenidate hydrochlorideMethylphenidate hydrochloride HEXAL 36 mg prolonged-release tabletsChange notification25.08.2025Other
Insulin glargineSemglee 100 units/ml solution for injection in pre-filled pen – OP(5x3ml)Change notification25.08.2025Other
LevetiracetamLevetiracetam – 1 A Pharma 1500 mg film-coated tabletsChange notification25.08.2025Other
2025年9月1日
このページの先頭へ戻る