BfArMボトルネック・レポート(2025年12月8日~12月14日)

Active ingredients
Message type
Date of last messageType of reasonAM designation
Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y)Change notification12.12.2025OtherFerrlecit 40 mg
Clomipramine hydrochlorideInitial report12.12.2025OtherClomipramine-neuraxpharm 75 mg retard
Epoetin zetaInitial report12.12.2025OtherRetacrit 40,000 IU/1 ml solution for injection in pre-filled syringe
Epoetin zetaInitial report12.12.2025OtherRetacrit 40,000 IU/1 ml solution for injection in pre-filled syringe
Atorvastatin calcium trihydrate (Ph.Eur.)Initial report11.12.2025OtherAtorvastatin Micro Labs 10 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification11.12.2025OtherAtorvastatin Micro Labs 30 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification11.12.2025OtherAtorvastatin Micro Labs 60 mg film-coated tablets
Fluoxetine hydrochlorideChange notification11.12.2025OtherFluoxetine Micro Labs 60 mg hard capsules
Fluoxetine hydrochlorideChange notification11.12.2025OtherFluoxetine Micro Labs 30 mg hard capsules
Quetiapine fumarate (Ph.Eur.)Change notification11.12.2025OtherQuetiapine AL 200 mg prolonged-release tablets
PrednicarbateChange notification11.12.2025OtherPrednicarbate acis solution
Zoledronic acid monohydrateInitial report11.12.2025OtherZoledronic acid AL 4 mg/100 ml infusion solution
Ibandronate sodium monohydrateInitial report11.12.2025OtherIbandronic acid AL 3 mg solution for injection in a pre-filled syringe
Fibrinogen, humanInitial report10.12.2025OtherFibryga
Sodium (hydrocortisone-21-succinate)Change notification10.12.2025Production problemHydrocortisone PANPHARMA 100 mg
Methylphenidate hydrochlorideChange notification10.12.2025OtherCONCERTA 54 mg prolonged-release tablets
Methylphenidate hydrochlorideChange notification10.12.2025OtherCONCERTA 36 mg prolonged-release tablets
Methylphenidate hydrochlorideChange notification10.12.2025OtherCONCERTA 27 mg prolonged-release tablets
Methylphenidate hydrochlorideChange notification10.12.2025OtherCONCERTA 18 mg prolonged-release tablets
DimenhydrinateInitial report10.12.2025Production problemDimenhydrinate PANPHARMA 6.2 mg/ml solution for injection (i.v.)
Metformin hydrochlorideInitial report10.12.2025OtherMetformin 500 – 1 A Pharma
Candesartan cilexetilInitial report10.12.2025OtherBlopress 16 mg
Colistimethate sodiumInitial report10.12.2025Production problemColistin CF
RisperidoneChange notification10.12.2025Production problemRisperidone-ratiopharm 50 mg powder and solvent for the preparation of a depot injection suspension
RisperidoneChange notification10.12.2025Production problemRisperidone-ratiopharm 37.5 mg powder and solvent for the preparation of a depot injection suspension
RisperidoneChange notification10.12.2025Production problemRisperidone-ratiopharm 25 mg powder and solvent for the preparation of a depot injection suspension
RibavirinChange notification10.12.2025Production problemRibavirin-ratiopharm 200 mg film-coated tablets
RibavirinChange notification10.12.2025OtherRibavirin-ratiopharm 400 mg film-coated tablets
Levothyroxine sodiumInitial report10.12.2025OtherL-thyroxine-Na-ratiopharm 50 microgram tablets
Levothyroxine sodiumInitial report10.12.2025OtherL-Thyroxine-Na-ratiopharm 25 microgram tablets
Isoniazid; pyridoxine hydrochlorideInitial report09.12.2025OtherIsozid comp. 200 mg N
IsoniazidInitial report09.12.2025OtherIsozid 0.5 N
PyrazinamideInitial report09.12.2025Production problemPyrafat 500mg
DapsoneInitial report09.12.2025Production problemDapson-Fatol
FilgrastimInitial report09.12.2025OtherNivestim 12 million E/0.2 ml injection/infusion solution – OP (5×0.2 ml)
AdalimumabInitial report09.12.2025OtherAmsparity
AdalimumabInitial report09.12.2025OtherAmsparity
AdalimumabInitial report09.12.2025OtherAmsparity
AdalimumabInitial report09.12.2025OtherAmsparity
Risedronate sodium 2.5 hydrate (Ph.Eur.)Initial report09.12.2025OtherRisedronate Aurobindo once weekly 35 mg film-coated tablets
Terazosin hydrochloride dihydrateChange notification09.12.2025OtherHeitrin 1mg
Terazosin hydrochloride dihydrateChange notification09.12.2025OtherHeitrin 5mg
Terazosin hydrochloride dihydrateChange notification09.12.2025OtherHeitrin 2 mg
Metamizole sodium monohydrateInitial report08.12.2025Production problemNovaminsulfon – 1 A Pharma Drops
Methylphenidate hydrochlorideInitial report08.12.2025OtherEquasym Retard 40 mg hard capsules with modified release
Atorvastatin calcium trihydrate (Ph.Eur.)Initial report08.12.2025OtherAtorvastatin – 1A Pharma 40 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Initial report08.12.2025OtherAtorvastatin – 1A Pharma 10 mg film-coated tablets
Quetiapine fumarate (Ph.Eur.)Change notification08.12.2025OtherSeroquel Prolong 50 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification08.12.2025OtherSeroquel Prolong 300 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification08.12.2025OtherSeroquel Prolong 200 mg prolonged-release tablets
2025年12月15日
このページの先頭へ戻る