BfArMボトルネック・レポート（2025年12月22日～2026年1月4日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
BCG bacteria, strain TICE, live, attenuatedChange notification02.01.2026OtherOncoTICE
Salbutamol sulfateChange notification02.01.2026OtherSalbuHEXAL N Metered dose inhaler
Salbutamol sulfateChange notification02.01.2026OtherSalbutamol – 1 A Pharma 0.1 mg pressurized gas inhalation, suspension
Epoetin thetaInitial report02.01.2026OtherEporatio 10,000 IU/1 ml injection solution in pre-filled syringe – OP (6x1ml)
Epoetin thetaInitial report02.01.2026OtherEporatio 4000 IU/0.5 ml injection solution in pre-filled syringe – OP (6×0.5 ml)
DigoxinInitial report30.12.2025Production problemLanicor
TeicoplaninChange notification29.12.2025OtherTeicoplanin Eberth 200 mg powder for solution for injection/infusion or oral solution
TeicoplaninChange notification29.12.2025OtherTeicoplanin Eberth 400 mg powder for solution for injection/infusion or oral solution
EtanerceptInitial report29.12.2025OtherNepexto 50 mg solution for injection in a pre-filled syringe
Insulin glargineChange notification29.12.2025OtherSemglee 100 units/ml solution for injection in a pre-filled pen – OP(5x3ml)
Insulin glargineChange notification29.12.2025OtherSemglee
Lanreotide acetate (1:x) ((with information on acetic acid content))Change notification29.12.2025Production problemMytolac 60 mg solution for injection in a pre-filled syringe
Fosfomycin sodium (Ph.Eur.)Change notification23.12.2025Production problemFosfomycin Eberth 2 g powder for solution for infusion
Fosfomycin sodium (Ph.Eur.)Change notification23.12.2025Production problemFosfomycin Eberth 4 g powder for solution for infusion
Galantamine hydrobromideChange notification23.12.2025Production problemGalantamine Heumann 24 mg hard capsules, delayed release
Galantamine hydrobromideChange notification23.12.2025Production problemGalantamine Heumann 16 mg hard capsules, delayed release
Galantamine hydrobromideChange notification23.12.2025Production problemGalantamine Heumann 8 mg hard capsules, delayed release
Quetiapine fumarate (Ph.Eur.)Change notification23.12.2025Production problemQuetiapine Heumann retard 300 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification23.12.2025Production problemQuetiapine Heumann retard 400 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification23.12.2025Production problemQuetiapine Heumann retard 50 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification23.12.2025Production problemQuetiapine Heumann retard 150 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification23.12.2025Production problemQuetiapine Heumann retard 200 mg prolonged-release tablets
Oxycodone hydrochloride (Ph.Eur.)Initial report22.12.2025Production problemOxygesic injection 10 mg/ml
Morphine hemisulfate 2.5 hydrateInitial report22.12.2025Production problemMSI 10 mg Mundipharma
Oxycodone hydrochlorideInitial report22.12.2025Production problemOxygesic 80 mg
AdalimumabChange notification22.12.2025OtherAmsparity
AdalimumabChange notification22.12.2025OtherAmsparity
FluconazoleChange notification22.12.2025OtherFlucoderm capsules 50 mg
Lidocaine hydrochloride monohydrateChange notification22.12.2025OtherXylocaine Gel 2%
HydrocortisoneInitial report22.12.2025OtherHydrocutan cream 1%
Fusidic acid (Ph.Eur.)Change notification22.12.2025OtherFusicutan ointment
ImiquimodChange notification22.12.2025Production problemImikeraderm 50 mg/g cream
Cefaclor monohydrateChange notification22.12.2025OtherCefaclor 125 TS – 1 A Pharma
2026年1月4日
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