BfArMボトルネック・レポート（2月2日～2月8日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
Salbutamol sulfateInitial report08.02.2026OtherSultanol forte ready-to-use inhalation solution
IsotretinoinChange notification06.02.2026OtherISOTRETINOIN BASICS 10 mg soft capsules
IsotretinoinInitial report06.02.2026OtherISOTRETINOIN BASICS 20 mg soft capsules
MitomycinChange notification06.02.2026OtherMitem 20mg
Epoetin alfaInitial report06.02.2026OtherEpoetin alfa HEXAL 40000 IU/1 ml solution for injection in pre-filled syringe – OP6
IvermectinChange notification06.02.2026OtherDRIPONIN 3 mg tablets
OxcarbazepineChange notification06.02.2026OtherOxcarbazepine – 1 A Pharma 60 mg/ml oral suspension
Pramipexole dihydrochloride monohydrateChange notification06.02.2026OtherPramipexole – 1 A Pharma 0.26 mg prolonged-release tablets
Dexamethasone dihydrogen phosphate disodium (Ph.Eur.)Initial report05.02.2026OtherDexabene
IbuprofenChange notification05.02.2026Production problemIbuprofen PUREN 600 mg film-coated tablets
DocetaxelChange notification05.02.2026Production problemDocetaxel Aurobindo 20 mg/ml concentrate for solution for infusion
Buprenorphine hydrochlorideChange notification05.02.2026OtherBuprenorphine PUREN 8 mg sublingual tablets
AnastrozoleChange notification05.02.2026Production problemAnastroPUREN 1 mg film-coated tablets
Quetiapine fumarate (Ph.Eur.)Change notification05.02.2026Production problemQuetiapine beta 150 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification05.02.2026Production problemQuetiapine beta 200 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification05.02.2026Production problemQuetiapine beta 300 mg prolonged-release tablets
Atomoxetine hydrochlorideChange notification05.02.2026Production problemAtomoxetine beta 18 mg hard capsules
Fluoxetine hydrochlorideChange notification05.02.2026OtherFluoxetine beta 20
Atomoxetine hydrochlorideChange notification05.02.2026Production problemAtomoxetine beta 80 mg hard capsules
AprepitantChange notification05.02.2026Production problemAprepitant beta 125 mg and 80 mg hard capsules
Tacrolimus monohydrateInitial report04.02.2026OtherTakrozem 1 mg/g ointment
Lidocaine hydrochloride monohydrateChange notification04.02.2026OtherXylocaine Gel 2%
AlprostadilInitial report04.02.2026OtherProstavasin 20 µg
GabapentinChange notification04.02.2026Production problemGabapentin Holsten 600 mg film-coated tablets
Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y)Change notification04.02.2026OtherFerrlecit 40 mg
RisperidoneChange notification04.02.2026Production problemRisperidone-ratiopharm 50 mg powder and solvent for the preparation of a depot injection suspension
RisperidoneChange notification04.02.2026Production problemRisperidone-ratiopharm 37.5 mg powder and solvent for the preparation of a depot injection suspension
RisperidoneChange notification04.02.2026Production problemRisperidone-ratiopharm 25 mg powder and solvent for the preparation of a depot injection suspension
Candesartan cilexetilInitial report03.02.2026OtherATACAND 16 mg
CrisantaspaseChange notification03.02.2026OtherErwinase 10,000 IU/vial powder for the preparation of an injection/infusion solution
CalcitriolInitial report03.02.2026OtherRenatriol 0.25 µg
CalcitriolInitial report03.02.2026OtherCalcitriol KyraMed 0.25 micrograms
Fluoxetine hydrochlorideChange notification03.02.2026OtherFluoxetine Micro Labs 30 mg hard capsules
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification03.02.2026OtherAtorvastatin Micro Labs 60 mg film-coated tablets
Prednisolone acetateInitial report03.02.2026Production problemPredni-POS 0.5%
Propranolol hydrochlorideChange notification03.02.2026OtherPropra-ratiopharm 10 mg film-coated tablets
Methylphenidate hydrochlorideInitial report03.02.2026OtherMethylphenidate-ratiopharm 30 mg modified-release hard capsules
Methylphenidate hydrochlorideInitial report03.02.2026OtherMethylphenidate-ratiopharm 20 mg modified-release hard capsules
Ipratropium bromide (Ph.Eur.)Change notification03.02.2026Production problemIpratropium Teva 250 micrograms/1 ml solution for nebulizer
Quetiapine fumarate (Ph.Eur.)Change notification03.02.2026OtherQuetiapine AbZ 150 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification03.02.2026OtherQuetiapine-ratiopharm 300 mg prolonged-release tablets
EverolimusChange notification03.02.2026OtherEverolimus-ratiopharm 5 mg tablets
EverolimusChange notification03.02.2026OtherEverolimus-ratiopharm 2.5 mg tablets
Doxepine hydrochloride (Ph.Eur.)Change notification03.02.2026OtherDoxepin-ratiopharm 25 mg film-coated tablets
AlprazolamChange notification03.02.2026OtherAlprazolam-ratiopharm 1.0 mg tablets
Prednisolone acetateChange notification03.02.2026Production problemPredni-POS 1%
Proxymetacaine hydrochlorideChange notification03.02.2026Production problemProparacaine-POS 0.5%
FluorometholoneChange notification03.02.2026Production problemFluoropos
Gentamicin sulfateChange notification03.02.2026Production problemGentamicin-POS
Salbutamol sulfateChange notification02.02.2026OtherBronchospray novo
2026年2月9日
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