BfArMボトルネック・レポート（1月19日～1月25日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
Quetiapine fumarate (Ph.Eur.)Change notification23.01.2026Production problemQuetiapine Glenmark 200 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification23.01.2026Production problemQuetiapine Glenmark 400 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification23.01.2026Production problemQuetiapine Glenmark 150 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification23.01.2026Production problemQuetiapine Glenmark 300 mg prolonged-release tablets
Rifampicin sodiumChange notification23.01.2026OtherEremfat i.v. 300mg
IvermectinChange notification23.01.2026OtherDRIPONIN 3 mg tablets
Galantamine hydrobromideChange notification23.01.2026Production problemGalantamine Glenmark 8 mg hard capsules, delayed release
Galantamine hydrobromideChange notification23.01.2026Production problemGalantamine Glenmark 24 mg hard capsules, delayed release
Galantamine hydrobromideChange notification23.01.2026Production problemGalantamine Glenmark 16 mg hard capsules, delayed release
Fibrinogen, humanChange notification23.01.2026OtherFibryga
IsoniazidInitial report23.01.2026OtherIsozid 50 mg
Mannitol (Ph.Eur.)Change notification23.01.2026OtherBronchitol 40 mg hard capsule with powder for inhalation – OP10(1×10)
Dexketoprofen trometamolChange notification23.01.2026Production problemSympal inject 50 mg solution for injection/infusion
Valaciclovir hydrochlorideInitial report22.01.2026OtherValaciclovir – 1A Pharma 500 mg film-coated tablets
Valaciclovir hydrochlorideInitial report22.01.2026OtherValaciclovir – 1A Pharma 1000 mg film-coated tablets
Fluoxetine hydrochlorideChange notification22.01.2026OtherFluoxetine Micro Labs 30 mg hard capsules
Clomipramine hydrochlorideChange notification22.01.2026Production problemAnafranil 75 mg retard
Ropivacaine hydrochloride monohydrateInitial report21.01.2026Production problemNAROPIN 10mg/ml Amp.10ml Solution for injection
Ropivacaine hydrochloride monohydrateInitial report21.01.2026OtherNAROPIN 2 mg/ml Amp. 20 ml Solution for injection
Quetiapine fumarate (Ph.Eur.)Change notification21.01.2026OtherSeroquel Prolong 200 mg prolonged-release tablets
Epirubicin hydrochlorideChange notification21.01.2026Production problemEpirubicin Hikma 2 mg/ml concentrate for solution for infusion
Vancomycin hydrochlorideChange notification21.01.2026OtherVancomycin CP 500mg
Lidocaine hydrochloride monohydrateChange notification21.01.2026OtherXylocaine Gel 2%
Cyclophosphamide monohydrateInitial report21.01.2026Production problemEndoxan 200 mg
Cyclophosphamide monohydrateInitial report21.01.2026Production problemEndoxan 500 mg
Cyclophosphamide monohydrateInitial report21.01.2026Production problemEndoxan 1 g
IfosfamideInitial report21.01.2026Production problemHoloxan
Phenobarbital sodiumChange notification20.01.2026OtherLuminal injection solution
Salbutamol sulfateInitial report20.01.2026OtherBronchospray Autohaler
LorazepamChange notification20.01.2026OtherTavor 2.5 mg Expidet
Epinephrine/AdrenalineChange notification20.01.2026Production problemAnapen 500 micrograms solution for injection
Insulin glargineChange notification20.01.2026OtherSemglee
Insulin glargineChange notification20.01.2026OtherSemglee 100 units/ml solution for injection in pre-filled pen – OP (5x3ml)
Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y)Change notification20.01.2026OtherFerrlecit 40 mg
Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y)Change notification20.01.2026OtherFerrlecit 62.5 mg
Tamsulosin hydrochlorideChange notification20.01.2026OtherTamsulosin hydrochloride PUREN 0.4 mg prolonged-release capsules
PregabalinChange notification20.01.2026OtherPregabalin Aurobindo 25 mg hard capsules
Buprenorphine hydrochlorideChange notification20.01.2026OtherBuprenorphine PUREN 8 mg sublingual tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification20.01.2026OtherAtorvastatin PUREN 40 mg film-coated tablets
Rosuvastatin calcium (Ph.Eur.)Change notification20.01.2026OtherRosuvastatin Aurobindo 20 mg film-coated tablets
AnastrozoleChange notification20.01.2026OtherAnastrozole Denk 1 mg film-coated tablets
Propranolol hydrochlorideInitial report19.01.2026OtherDOCITON 10mg
NitrendipineInitial report19.01.2026OtherNitrendipine Aristo 10 mg film-coated tablets
Arsenic(III) oxideChange notification19.01.2026OtherTRISENOX 2 mg/ml concentrate for solution for infusion
DinoprostInitial report19.01.2026OtherPropess 10 mg vaginal delivery system
AdalimumabChange notification19.01.2026OtherAmsparity
AdalimumabChange notification19.01.2026OtherAmsparity
Methanthelinium bromideInitial report19.01.2026Production problemVagantin RIEMSER
Betamethasone dipropionate (Ph.Eur.); salicylic acidInitial report19.01.2026OtherSoderm plus solution 0.64 mg/g + 20 mg/g solution for application to the skin
2026年1月26日
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