BfArMボトルネック・レポート（1月5日～2月1日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
Atomoxetine hydrochlorideChange notification30.01.2026OtherAtomoxe – 1 A Pharma 10 mg hard capsules
Valaciclovir hydrochlorideChange notification30.01.2026OtherValaciclovir – 1A Pharma 500 mg film-coated tablets
Salbutamol sulfateChange notification30.01.2026OtherSalbuHEXAL N metered-dose inhaler
Salbutamol sulfateChange notification30.01.2026OtherSalbutamol – 1 A Pharma 0.1 mg pressurized gas inhalation, suspension
LorazepamChange notification30.01.2026OtherTavor 2.5 mg Expidet
Quetiapine fumarate (Ph.Eur.)Change notification30.01.2026Production problemQuetiapine – 1 A Pharma 600 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification30.01.2026Production problemQuetiapine – 1 A Pharma 50 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification30.01.2026Production problemQuetiapine – 1 A Pharma 300 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification30.01.2026Production problemQuetiapine – 1 A Pharma 200 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification30.01.2026Production problemQuetiapine – 1 A Pharma 150 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification30.01.2026Production problemQuetiapine HEXAL 50 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification30.01.2026Production problemQuetiapine HEXAL 400 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification30.01.2026Production problemQuetiapine HEXAL 200 mg prolonged-release tablets
Methylphenidate hydrochlorideChange notification30.01.2026OtherMethylphenidate hydrochloride HEXAL 36 mg prolonged-release tablets
LevetiracetamChange notification30.01.2026OtherLevetiracetam – 1 A Pharma 1500 mg film-coated tablets
Ciprofloxacin hydrochloride (1:1) 1 H<2>OChange notification30.01.2026OtherCiprohexal 100 mg
Ciprofloxacin hydrochloride (1:1) 1 H<2>OChange notification30.01.2026OtherCipro-1 A Pharma 100 mg
Trimipramine mesylateChange notification30.01.2026OtherTrimipramine – 1 A Pharma 40 mg/ml Oral drops, solution
OxytocinChange notification30.01.2026Production problemOxytocin 3 I.E. Hexal
Insulin glargineChange notification30.01.2026OtherSemglee
AlprazolamChange notification30.01.2026OtherAlprazolam – 1 A Pharma 0.5 mg tablets
ChlortalidoneChange notification30.01.2026OtherChlortalidone HEXAL 12.5 mg tablets
DinoprostoneChange notification30.01.2026OtherPropess 10 mg vaginal delivery system
RifampicinChange notification30.01.2026Production problemEremfat syrup
Ezetimibe; simvastatinChange notification30.01.2026Production problemEZETIMIB/SIMVA BASICS 10 mg/80 mg tablets
Ezetimibe; simvastatinChange notification30.01.2026Production problemEZETIMIB/SIMVA BASICS 10 mg/40 mg tablets
Ezetimibe; simvastatinChange notification30.01.2026Production problemEZETIMIB/SIMVA BASICS 10 mg/20 mg tablets
Ezetimibe; simvastatinChange notification30.01.2026Production problemEZETIMIB/SIMVA BASICS 10 mg/10 mg tablets
Ciprofloxacin hydrochloride monohydrateChange notification30.01.2026OtherCIPRO BASICS 750 mg film-coated tablets
Ciprofloxacin hydrochloride monohydrateChange notification30.01.2026OtherCIPRO BASICS 250 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification30.01.2026OtherATORVASTATIN BASICS 30 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification30.01.2026OtherATORVASTATIN BASICS 20 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification30.01.2026OtherATORVASTATIN BASICS 10 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification30.01.2026OtherATORVASTATIN BASICS 80 mg film-coated tablets
Candesartan cilexetilChange notification30.01.2026OtherCANDESARTAN BASICS 32 mg tablets
Candesartan cilexetilChange notification30.01.2026OtherCANDESARTAN BASICS 16 mg tablets
Candesartan cilexetilChange notification30.01.2026OtherCANDESARTAN BASICS 8 mg tablets
Candesartan cilexetilChange notification30.01.2026OtherCANDESARTAN BASICS 4 mg tablets
Esomeprazole hemimagnesiumChange notification30.01.2026Production problemESOMEPRAZOLE BASICS 40 mg gastro-resistant hard capsules
Esomeprazole hemimagnesiumChange notification30.01.2026Production problemESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsules
Quetiapine fumarate (Ph.Eur.)Initial report30.01.2026OtherSeroquel Prolong 400 mg prolonged-release tablets
Clonidine hydrochlorideInitial report29.01.2026OtherCatapresan 300
Pramipexole dihydrochloride monohydrateChange notification29.01.2026OtherPramipexole-ratiopharm 0.52 mg prolonged-release tablets
Folic acid hydrate (with information on water content (1:x))Initial report29.01.2026Production problemFolsan 0.4 mg
Methyldopa (Ph.Eur.)Initial report29.01.2026Production problemPresinol 500
PrednicarbatInitial report29.01.2026OtherPrednitop Crinale
Mometasone furoate (Ph.Eur.)Change notification29.01.2026Production problemMomecutan solution
Imatinib mesylateInitial report28.01.2026OtherImatinib Denk 100 mg film-coated tablets
Amlodipine besylate; Perindopril tert-butylamineChange notification28.01.2026OtherPerindopril/Amlodipine Denk 4 mg/10 mg tablets
Amlodipine besylate; Perindopril tert-butylamineChange notification28.01.2026OtherPerindopril/Amlodipine Denk 8 mg/10 mg tablets
Rifampicin sodiumChange notification28.01.2026OtherEremfat i.v. 600mg
Quetiapine fumarate (Ph.Eur.)Change notification28.01.2026OtherQuetiapine AL 50 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification28.01.2026OtherQuetiapine AL 150 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification28.01.2026OtherQuetiapine AL 300 mg prolonged-release tablets
AprepitantChange notification28.01.2026OtherAprepitant AL 80 mg hard capsules
AprepitantChange notification28.01.2026OtherAprepitant AL 125 mg hard capsules
NitrendipineChange notification28.01.2026OtherNitrendipine AL 20
NitrendipineChange notification28.01.2026OtherNitrendipine AL 10
Methylphenidate hydrochlorideChange notification28.01.2026OtherMETHYLPHENIDATE 20 mg tablets
Thioctic acid trometamol salt (1:1)Initial report28.01.2026OtherThioctacid 600 T
Duloxetine hydrochlorideInitial report27.01.2026Production problemDuloxetine Zentiva 30 mg gastro-resistant hard capsules
Duloxetine hydrochlorideInitial report27.01.2026Production problemDuloxetine Zentiva 60 mg gastro-resistant hard capsules
Doxepin hydrochloride (Ph.Eur.)Change notification27.01.2026OtherDoxepin 50 Holsten
GabapentinChange notification27.01.2026OtherGabapentin Holsten 100 mg hard capsules
Moxifloxacin hydrochloride (Ph.Eur.) ((with information on water content (1:x)))Change notification27.01.2026OtherMoxifloxacin Holsten 400 mg film-coated tablets
Atomoxetine hydrochlorideChange notification27.01.2026Production problemAtomoxetine-neuraxpharm 100 mg hard capsules
Atomoxetine hydrochlorideChange notification27.01.2026Production problemAtomoxetine-neuraxpharm 80 mg hard capsules
Atomoxetine hydrochlorideChange notification27.01.2026Production problemAtomoxetine-neuraxpharm 40 mg hard capsules
Atomoxetine hydrochlorideChange notification27.01.2026Production problemAtomoxetine-neuraxpharm 25 mg hard capsules
Atomoxetine hydrochlorideChange notification27.01.2026Production problemAtomoxetine-neuraxpharm 18 mg hard capsules
Atomoxetine hydrochlorideChange notification27.01.2026Production problemAtomoxetine-neuraxpharm 10 mg hard capsules
Atomoxetine hydrochlorideChange notification27.01.2026Production problemAtomoxetine-neuraxpharm 60 mg hard capsules
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification26.01.2026OtherAtorvastatin Micro Labs 60 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification26.01.2026OtherAtorvastatin Micro Labs 30 mg film-coated tablets
Fluoxetine hydrochlorideChange notification26.01.2026OtherFluoxetine Micro Labs 60 mg hard capsules
Fluoxetine hydrochlorideChange notification26.01.2026OtherFluoxetine Micro Labs 30 mg hard capsules
Naloxone hydrochloride dihydrate; oxycodone hydrochloride (Ph.Eur.)Change notification26.01.2026Production problemTargin 40 mg/20 mg prolonged-release tablets
ZonisamideChange notification26.01.2026Production problemZonisamide Glenmark 100 mg hard capsules
Levofloxacin hemihydrateChange notification26.01.2026Production problemLevofloxacin Kabi 5 mg/ml solution for infusion
Ciprofloxacin sulfate (1:1)Change notification26.01.2026Production problemCiprofloxacin Kabi 200 mg/100 ml solution for infusion
Rizatriptan benzoateChange notification26.01.2026Production problemRizatriptan Glenmark 5 mg tablets
Rizatriptan benzoateChange notification26.01.2026Production problemRizatriptan Glenmark 5 mg orodispersible tablets
Quetiapine fumarate (Ph.Eur.)Initial report26.01.2026Production problemQuetiapine Glenmark 50 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification26.01.2026Production problemQuetiapine Glenmark 150 mg prolonged-release tablets
2026年2月2日
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