BfArMボトルネック・レポート（2月23日～3月1日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
Fibrinogen, humanChange notification27.02.2026Production problemHaemocomplettan P 2g
Fibrinogen, humanChange notification27.02.2026Production problemHaemocomplettan P 1g
Atorvastatin calcium trihydrate (Ph.Eur.)Initial report27.02.2026OtherAtorvastatin Micro Labs 80 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification27.02.2026OtherAtorvastatin Micro Labs 30 mg film-coated tablets
Efavirenz; emtricitabine; tenofovir disoproxilInitial report27.02.2026Production problemEfavirenz/emtricitabine/tenofovir disoproxil Heumann 600 mg/200 mg/245 mg film-coated tablets
MesalazineInitial report27.02.2026OtherAsacol 1600 mg modified-release tablet
Arsenic(III) oxideChange notification27.02.2026OtherTRISENOX 2 mg/ml concentrate for solution for infusion
Valaciclovir hydrochlorideChange notification27.02.2026OtherValaciclovir – 1A Pharma 500 mg film-coated tablets
Dexketoprofen trometamolChange notification27.02.2026Production problemSympal inject 50 mg solution for injection/infusion
Quetiapine fumarate (Ph.Eur.)Change notification27.02.2026Production problemQuetiapine – 1 A Pharma 400 mg prolonged-release tablets
Rifampicin sodiumChange notification27.02.2026OtherEremfat i.v. 600mg
OxcarbazepineChange notification27.02.2026OtherOxcarbazepine – 1 A Pharma 60 mg/ml oral suspension
ImiquimodInitial report27.02.2026OtherAKSUNIM 50 mg/g cream
OxytocinChange notification27.02.2026Production problemOxytocin 3 I.E. Hexal
Esomeprazole hemimagnesiumChange notification26.02.2026Production problemESOMEPRAZOLE BASICS 40 mg gastro-resistant hard capsules
Esomeprazole hemimagnesiumChange notification26.02.2026Production problemESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsules
Ezetimibe; simvastatinChange notification26.02.2026Production problemEZETIMIBE/SIMVA BASICS 10 mg/10 mg tablets
Ezetimibe; simvastatinChange notification26.02.2026Production problemEZETIMIBE/SIMVA BASICS 10 mg/20 mg tablets
Ezetimibe; simvastatinChange notification26.02.2026Production problemEZETIMIBE/SIMVA BASICS 10 mg/40 mg tablets
Ezetimibe; simvastatinChange notification26.02.2026Production problemEZETIMIB/SIMVA BASICS 10 mg/80 mg tablets
IsotretinoinChange notification26.02.2026OtherISOTRETINOIN BASICS 20 mg soft capsules
IsotretinoinChange notification26.02.2026OtherISOTRETINOIN BASICS 10 mg soft capsules
Ciprofloxacin hydrochloride monohydrateChange notification26.02.2026OtherCIPRO BASICS 250 mg film-coated tablets
Ciprofloxacin hydrochloride monohydrateChange notification26.02.2026OtherCIPRO BASICS 750 mg film-coated tablets
Ciprofloxacin hydrochloride monohydrateChange notification26.02.2026OtherCIPRO BASICS 500 mg film-coated tablets
Candesartan cilexetilChange notification26.02.2026OtherCANDESARTAN BASICS 8 mg tablets
Candesartan cilexetilChange notification26.02.2026OtherCANDESARTAN BASICS 4 mg tablets
Candesartan cilexetilChange notification26.02.2026OtherCANDESARTAN BASICS 32 mg tablets
Candesartan cilexetilChange notification26.02.2026OtherCANDESARTAN BASICS 16 mg tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification26.02.2026OtherATORVASTATIN BASICS 30 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification26.02.2026OtherATORVASTATIN BASICS 40 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification26.02.2026OtherATORVASTATIN BASICS 80 mg film-coated tablets
TobramycinInitial report26.02.2026OtherTobramycin SUN 300 mg solution for nebulizer
LacosamideChange notification26.02.2026OtherVimpat 100 mg film-coated tablets – OP14
Hydrochlorothiazide; Losartan potassiumInitial report26.02.2026OtherLosarHCT-Denk 50 mg/12.5 mg film-coated tablets
Imatinib mesylateChange notification26.02.2026OtherImatinib Denk 100 mg film-coated tablets
Quetiapine fumarate (Ph.Eur.)Change notification26.02.2026OtherSeroquel Prolong 200 mg prolonged-release tablets
Clonidine hydrochlorideInitial report26.02.2026OtherCatapresan 150
Paliperidone palmitateChange notification26.02.2026OtherNiapelf
Sodium valproate; valproic acidInitial report26.02.2026OtherValpro AL 300 mg prolonged-release tablets
Eletriptan hydrobromideInitial report26.02.2026Production problemEletriptan Bluefish 20 mg film-coated tablets
Alanine; Arginine; Glycine; Histidine; Isoleucine; Leucine; Lysine acetate; Methionine; Phenylalanine; Proline; Serine; Taurine; Threonine; Tryptophan; Tyrosine; ValineInitial report26.02.2026OtherAminoven 10%
Acetylcysteine; alanine; arginine; acetic acid 99%; glycine; histidine; isoleucine; leucine; lysine acetate; methionine; phenylalanine; proline; serine; threonine; tryptophan; valineInitial report26.02.2026OtherAminosteril N-Hepa 8%
Acetylcysteine; alanine; arginine; glycine; histidine; isoleucine; L-malic acid; leucine; lysine acetate; methionine; N-acetyl tyrosine (Ph.Eur.); phenylalanine; proline; serine; taurine; threonine; tryptophan; valineInitial report26.02.2026OtherAminoven infant 10%
PrednisoloneInitial report26.02.2026OtherPrednisolone AL 20 mg tablets
Nilotinib hydrochloride dihydrateInitial report26.02.2026OtherNilotinib AL 50 mg hard capsules
Calcium folinate hydrateChange notification26.02.2026Production problemCalcium folinate onkovis 10 mg/ml solution for injection
Rosuvastatin hemicalciumChange notification25.02.2026OtherRosuvastatin Aristo 5 mg film-coated tablets
Dexamethasone dihydrogen phosphate disodium (Ph.Eur.)Change notification25.02.2026OtherDexafluid 1 mg/ml eye drops
Betamethasone dipropionate (Ph.Eur.); calcipotriol monohydrateInitial report25.02.2026OtherCalcipotriol comp. 50 micrograms/g + 0.5 mg/g gel
Quetiapine fumarate (Ph.Eur.)Change notification25.02.2026OtherQuetiapine-neuraxpharm 600 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification25.02.2026OtherQuetiapine-neuraxpharm 400 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification25.02.2026OtherQuetiapine-neuraxpharm 300 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification25.02.2026OtherQuetiapine-neuraxpharm 200 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification25.02.2026OtherQuetiapine-neuraxpharm 150 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification25.02.2026OtherQuetiapine-neuraxpharm 50 mg prolonged-release tablets
Propranolol hydrochlorideInitial report25.02.2026OtherPropranolol AL 80
PregabalinInitial report25.02.2026OtherPregabalin Aurobindo 200 mg hard capsules
Quetiapine fumarate (Ph.Eur.)Change notification25.02.2026OtherSeroquel Prolong 150 mg prolonged-release tablets
RisperidoneInitial report25.02.2026OtherRisperidone Aurobindo 1 mg film-coated tablets
FlutamideChange notification25.02.2026OtherFlutamide AL 250
Sumatriptan succinateInitial report25.02.2026OtherSumatriptan Aurobindo 50 mg tablets
Rizatriptan benzoateInitial report25.02.2026OtherRizatriptan Aurobindo 10 mg tablets
LamotrigineChange notification25.02.2026Production problemLamotrigine Aurobindo 5 mg tablets for oral suspension
Dutasteride; tamsulosin hydrochlorideChange notification25.02.2026Production problemDutasteride/tamsulosin PUREN 0.5 mg/0.4 mg hard capsules
Buprenorphine hydrochlorideChange notification25.02.2026OtherBuprenorphine PUREN 8 mg sublingual tablets
Propranolol hydrochlorideInitial report25.02.2026OtherPropranolol-CT 80 mg film-coated tablets
Propranolol hydrochlorideInitial report25.02.2026OtherPropranolol-CT 40 mg film-coated tablets
Arsenic(III) oxideChange notification25.02.2026Production problemArsenic trioxide STADA 1 mg/ml concentrate for solution for infusion
Tranexamic acidChange notification24.02.2026Production problemTranexamic acid PUREN 100 mg/ml solution for injection
Risedronate sodium 2.5 hydrate (Ph.Eur.)Change notification24.02.2026OtherRisedronate Aurobindo once weekly 35 mg film-coated tablets
RisperidoneChange notification24.02.2026OtherRisperidone PUREN 3 mg film-coated tablets
FlurazepamChange notification24.02.2026Production problemFlurazepam real
TropicamideChange notification24.02.2026Production problemMydriaticum Stulln UD
Quetiapine fumarate (Ph.Eur.)Initial report24.02.2026OtherSeroquel Prolong 50 mg prolonged-release tablets
RitonavirChange notification24.02.2026OtherRitonavir Viatris 100 mg film-coated tablets – OP30
Ethambutol dihydrochlorideInitial report24.02.2026Production problemEMB-FATOL 500 mg
Valaciclovir hydrochlorideInitial report24.02.2026Production problemValaciclovir Aurobindo 500 mg film-coated tablets
Ethambutol dihydrochlorideInitial report24.02.2026OtherEMB-FATOL 100 mg
Thioctic acid trometamol salt (1:1)Change notification24.02.2026OtherThioctacid 600 T
TelmisartanInitial report23.02.2026OtherTelmisartan Micro Labs 20 mg tablets
EntecavirInitial report23.02.2026Production problemBaraclude 0.5 mg film-coated tablets – OP90(90×1)
Doxorubicin hydrochlorideChange notification23.02.2026Production problemDOXO-cell 150 mg solution for injection
Doxorubicin hydrochlorideChange notification23.02.2026Production problemDOXO-cell 50 mg solution for injection
Mivacurium chlorideChange notification23.02.2026Production problemMivacron 20mg
Amlodipine besylate; Hydrochlorothiazide; ValsartanInitial report23.02.2026OtherAmlodipine/Valsartan/HCT Holsten 10 mg/160 mg/25 mg film-coated tablets
PrimidoneChange notification23.02.2026OtherPrimidone Holsten
2026年3月3日
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