BfArMボトルネック・レポート（2025年10月6日～10月12日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
Tinzaparin sodiumChange notification10.10.2025Production probleminnohep 4,500 Anti-Xa I.E. Solution for injection
CarbamazepineInitial report09.10.2025Production problemCarbamazepine Aristo 600 mg prolonged-release tablets
CarbamazepineInitial report09.10.2025Production problemCarbamazepine Aristo 300 mg prolonged-release tablets
Ezetimibe; simvastatinChange notification09.10.2025Production problemEZETIMIB/SIMVA BASICS 10 mg/80 mg tablets
Ezetimibe; simvastatinChange notification09.10.2025Production problemEZETIMIB/SIMVA BASICS 10 mg/40 mg tablets
Ezetimibe; simvastatinChange notification09.10.2025Production problemEZETIMIB/SIMVA BASICS 10 mg/20 mg tablets
Ezetimibe; simvastatinChange notification09.10.2025Production problemEZETIMIBE/SIMVA BASICS 10 mg/10 mg tablets
Esomeprazole hemimagnesiumChange notification09.10.2025Production problemESOMEPRAZOLE BASICS 40 mg gastro-resistant hard capsules
Esomeprazole hemimagnesiumChange notification09.10.2025Production problemESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsules
Moxifloxacin hydrochloride (Ph.Eur.) ((with information on water content (1:x)))Initial report09.10.2025OtherMoxifloxacin Holsten 400 mg film-coated tablets
LeflunomideInitial report09.10.2025OtherLeflunomide Bluefish 20 mg film-coated tablets
Methylphenidate hydrochlorideChange notification09.10.2025OtherMETHYLPHENIDATE 20 mg tablets
Methylphenidate hydrochlorideChange notification09.10.2025OtherMETHYLPHENIDATE 5 mg tablets
LeflunomideInitial report09.10.2025OtherLeflunomide Bluefish 10 mg film-coated tablets
Potassium canrenoateChange notification09.10.2025Production problemAldactone 10 ml Canrenoate
UrapidilInitial report09.10.2025Production problemUrapidil Bluefish 90 mg hard capsules, delayed release
UrapidilInitial report09.10.2025Production problemUrapidil Bluefish 30 mg hard capsules, delayed release
Methylphenidate hydrochlorideChange notification09.10.2025OtherMethylphenidate-ratiopharm 40 mg hard capsules with modified release
PrimidoneChange notification09.10.2025Production problemMylepsinum
Quetiapine fumarate (Ph.Eur.)Change notification09.10.2025OtherQuetiapine AbZ 150 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification09.10.2025OtherQuetiapine-ratiopharm 300 mg prolonged-release tablets
RisperidoneChange notification09.10.2025Production problemRisperidone-ratiopharm 25 mg powder and solvent for the preparation of a depot injection suspension
RisperidoneChange notification09.10.2025Production problemRisperidone-ratiopharm 37.5 mg powder and solvent for the preparation of a depot injection suspension
RisperidoneChange notification09.10.2025Production problemRisperidone-ratiopharm 50 mg powder and solvent for the preparation of a depot injection suspension
Pramipexole dihydrochloride monohydrateChange notification09.10.2025OtherPramipexole-ratiopharm 0.52 mg prolonged-release tablets
Pramipexole dihydrochloride monohydrateChange notification09.10.2025OtherPramipexole-ratiopharm 0.26 mg prolonged-release tablets
CarbamazepineChange notification09.10.2025OtherCarbamazepine-ratiopharm 400 mg prolonged-release tablets
CarbamazepineChange notification09.10.2025OtherCarbamazepine-ratiopharm 200 mg prolonged-release tablets
RibavirinChange notification09.10.2025OtherRibavirin-ratiopharm 400 mg film-coated tablets
RibavirinChange notification09.10.2025OtherRibavirin-ratiopharm 200 mg film-coated tablets
Salbutamol sulfateInitial report09.10.2025OtherSultanol metered-dose inhaler
AprepitantChange notification09.10.2025Production problemAprepitant STADA 125 mg hard capsules
Human insulin (with manufacturing details); isophane insulin suspension for injection (Ph.Eur.)Change notification08.10.2025OtherActraphane 30 FlexPen 100 IU/ml injection suspension in injector – OP(10x3ml)
Isophane insulin suspension for injection (Ph.Eur.)Change notification08.10.2025OtherProtaphane FlexPen 100 IU/ml injection suspension in injector – OP(10x3ml)
NitrendipineChange notification08.10.2025OtherNitrendipine AL 20
AprepitantChange notification08.10.2025OtherAprepitant AL 125 mg hard capsules
OxazepamChange notification08.10.2025OtherOxazepam AL 10
Quetiapine fumarate (Ph.Eur.)Change notification08.10.2025OtherQuetiapine AL 50 mg prolonged-release tablets
Amoxicillin trihydrateChange notification08.10.2025OtherAmoxicillin AL TS
Doxepin hydrochloride (Ph.Eur.)Change notification07.10.2025Production problemDoxepin 25 Holsten
Azithromycin dihydrateChange notification07.10.2025OtherAzithromycin AL 250 mg film-coated tablets
LacosamideInitial report07.10.2025Production problemLacosamide UCB 10 mg/ml syrup
AprepitantChange notification07.10.2025Production problemAprepitant beta 80 mg hard capsules
Quetiapine fumarate (Ph.Eur.)Change notification07.10.2025Production problemQuetiapine beta 50 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification07.10.2025Production problemQuetiapine beta 300 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification07.10.2025Production problemQuetiapine beta 200 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification07.10.2025Production problemQuetiapine beta 150 mg prolonged-release tablets
Atomoxetine hydrochlorideChange notification07.10.2025Production problemAtomoxetine beta 80 mg hard capsules
AprepitantChange notification07.10.2025Production problemAprepitant beta 125 mg and 80 mg hard capsules
Quetiapine fumarate (Ph.Eur.)Change notification07.10.2025OtherSeroquel Prolong 200 mg prolonged-release tablets
Amlodipine besylate; Perindopril tert-butylamineChange notification07.10.2025OtherPerindopril/amlodipine Denk 4 mg/5 mg tablets
Amlodipine besylate; Perindopril tert-butylamineChange notification07.10.2025OtherPerindopril/amlodipine Denk 4 mg/10 mg tablets
Amlodipine besylate; Perindopril tert-butylamineChange notification07.10.2025OtherPerindopril/Amlodipine Denk 8 mg/10 mg tablets
Clopidogrel besylateChange notification07.10.2025OtherClopidogrel Denk 75 mg film-coated tablets
Methylphenidate hydrochlorideChange notification07.10.2025OtherMethylphenidate AL 36 mg prolonged-release tablets
Methylphenidate hydrochlorideChange notification07.10.2025OtherMethylphenidate AL 27 mg prolonged-release tablets
Epirubicin hydrochlorideChange notification07.10.2025Production problemEpirubicin Hikma 2 mg/ml concentrate for solution for infusion
Trimipramine mesylateChange notification06.10.2025OtherTrimipramine – 1 A Pharma 40 mg/ml oral drops, solution
Tenofovir disoproxilInitial report06.10.2025OtherTenofovir disoproxil Viatris 245 mg film-coated tablets – OP30
Tenofovir disoproxilChange notification06.10.2025OtherTenofovir disoproxil Mylan 245 mg film-coated tablets – OP90(3×30)
ImiquimodChange notification06.10.2025Production problemAldara 5% cream – OP24
Dacarbazine citrateChange notification06.10.2025OtherDacarbazine Lipomed 500 mg powder for solution for infusion
Prednisolone acetateChange notification06.10.2025Production problemPrednifluid 10 mg/ml eye drop suspension
SevelamerChange notification06.10.2025OtherRenagel 800 mg film-coated tablets – OP(1×180)
Methylphenidate hydrochlorideChange notification06.10.2025OtherMethylphenidate hydrochloride-neuraxpharm 27 mg prolonged-release tablets
Phenylephrine hydrochlorideChange notification06.10.2025Production problemNeosynephrine-POS 10%
Gentamicin sulfateChange notification06.10.2025Production problemGentamicin-POS
Beclometasone dipropionate (Ph.Eur.)Change notification06.10.2025OtherBeclorhinol aquosum 50 micrograms
2025年10月13日
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