BfArMボトルネック・レポート(2025年10月20日~10月26日)

Active ingredients
Message type
Date of last messageType of reasonAM designation
Beclometasone dipropionate (Ph.Eur.)Initial report24.10.2025OtherBeclorhinol aquosum 50 micrograms
Rifampicin sodiumChange notification24.10.2025OtherEremfat i.v. 600mg
NimodipineInitial report24.10.2025OtherNimodipine Hexal 30 mg
Mivacurium chlorideChange notification23.10.2025Production problemMivacron 10mg
LorazepamChange notification23.10.2025OtherTavor 2.5 mg Expidet
Quetiapine fumarate (Ph.Eur.)Change notification23.10.2025OtherQuetiapine Hormosan 150 mg prolonged-release tablets
MisoprostolInitial report23.10.2025OtherAngusta 25 microgram tablets
Epoetin betaChange notification23.10.2025OtherNeoRecormon 5000 IU solution for injection in pre-filled syringe – OP6
Epoetin betaChange notification23.10.2025OtherNeoRecormon 3000 IU solution for injection in pre-filled syringe – OP6
Epoetin betaChange notification23.10.2025OtherNeoRecormon 4000 IU solution for injection in pre-filled syringe – OP6
Epoetin betaChange notification23.10.2025OtherNeoRecormon 2000 IU solution for injection in pre-filled syringe – OP6
Insulin lisproInitial report23.10.2025OtherLiprolog Mix25 100 IU/ml KwikPen injection suspension – OP[2x(5x3ml)]
ThiamazoleInitial report22.10.2025OtherThiamazole 5mg Henning
Acetylcholine chlorideChange notification22.10.2025Production problemMiochol-E Powder and solvent for the preparation of an instillation solution for intraocular use
ThiamazoleInitial report22.10.2025OtherThiamazole 20 mg Henning
Quetiapine fumarate (Ph.Eur.)Initial report22.10.2025Production problemQuetiapine Accord 400 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Initial report22.10.2025Production problemQuetiapine Accord 200 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Initial report22.10.2025Production problemQuetiapine Accord 150 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification22.10.2025Production problemQuetiapine Accord 50 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification22.10.2025Production problemQuetiapine Accord 300 mg prolonged-release tablets
Insulin glargineChange notification22.10.2025OtherSemglee
PirfenidoneChange notification22.10.2025Production problemPirfenidone Accord 801 mg film-coated tablets
Amikacin sulfateChange notification22.10.2025Production problemAmikacin B. Braun 5 mg/ml solution for infusion
Amikacin sulfateChange notification22.10.2025Production problemAmikacin B. Braun 2.5 mg/ml solution for infusion
FlutamideInitial report22.10.2025OtherFlutamide AL 250
CarbamazepineInitial report21.10.2025OtherTimonil Syrup
Tinzaparin sodiumInitial report21.10.2025Production probleminnohep 20,000 Anti-Xa I.E./ml Vials Solution for injection
Methylphenidate hydrochlorideChange notification21.10.2025OtherEquasym Retard 40 mg modified-release hard capsules
Methyldopa (Ph.Eur.)Initial report21.10.2025OtherDopegyt tablets
IbuprofenChange notification21.10.2025OtherIBU-PUREN acute 400 mg film-coated tablets
CarbamazepineChange notification21.10.2025OtherCarbadura 400 mg retard
Methylphenidate hydrochlorideChange notification20.10.2025OtherMETHYLPHENIDATE 20 mg tablets
Human insulin (with manufacturing details)Initial report20.10.2025OtherBerlinsulin H 30/70 3 ml pen
IsotretinoinInitial report20.10.2025OtherISOTRETINOIN BASICS 10 mg soft capsules
FampridineChange notification20.10.2025OtherFAMPRIDIN BASICS 10 mg prolonged-release tablets
Pramipexole dihydrochloride monohydrateChange notification20.10.2025OtherPramipexole Mylan 0.26 mg prolonged-release tablets
Pramipexole dihydrochloride monohydrateChange notification20.10.2025OtherPramipexole Mylan 0.52 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Initial report20.10.2025OtherSeroquel Prolong 300 mg prolonged-release tablets
Sodium (hydrocortisone-21-succinate)Change notification20.10.2025Production problemHydrocortisone PANPHARMA 250 mg
2025年10月27日
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