BfArMボトルネック・レポート（2月9日～2月15日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
Trimipramine mesylateChange notification13.02.2026OtherTrimipramine – 1 A Pharma 40 mg/ml oral drops, solution
AlprazolamChange notification13.02.2026OtherAlprazolam – 1 A Pharma 0.5 mg tablets
ChlortalidoneChange notification13.02.2026OtherChlortalidone HEXAL 12.5 mg tablets
Dexketoprofen trometamolChange notification13.02.2026Production problemSympal inject 50 mg injection/infusion solution
AnastrozoleChange notification13.02.2026Production problemAnastroPUREN 1 mg film-coated tablets
IsoniazidChange notification13.02.2026OtherIsozid 100 mg
Potassium iodide; levothyroxine sodiumChange notification13.02.2026OtherThyronajod 75 Henning
Potassium iodide; levothyroxine sodiumInitial report13.02.2026OtherThyronajod 100 Henning
Atorvastatin calcium trihydrate (Ph.Eur.)Initial report12.02.2026OtherATORVASTATIN BASICS 60 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification12.02.2026OtherATORVASTATIN BASICS 30 mg film-coated tablets
Ciprofloxacin hydrochloride monohydrateInitial report12.02.2026OtherCIPRO BASICS 500 mg film-coated tablets
Esomeprazole hemimagnesiumChange notification12.02.2026Production problemESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsules
Candesartan cilexetilChange notification12.02.2026OtherCANDESARTAN BASICS 4 mg tablets
Candesartan cilexetilChange notification12.02.2026OtherCANDESARTAN BASICS 8 mg tablets
Candesartan cilexetilChange notification12.02.2026OtherCANDESARTAN BASICS 32 mg tablets
Ciprofloxacin hydrochloride monohydrateChange notification12.02.2026OtherCIPRO BASICS 250 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Initial report12.02.2026OtherATORVASTATIN BASICS 40 mg film-coated tablets
Esomeprazole hemimagnesiumChange notification12.02.2026Production problemESOMEPRAZOLE BASICS 40 mg gastro-resistant hard capsules
Tacrolimus monohydrateInitial report12.02.2026Production problemTacpan 5 mg hard capsules
ZidovudineInitial report12.02.2026Production problemZidovudine Aurobindo 250 mg hard capsules
Ondansetron hydrochloride dihydrateInitial report12.02.2026Production problemOndansetron Aurobindo 4 mg film-coated tablets
Escitalopram oxalateInitial report12.02.2026OtherEscitalopram Aurobindo 10 mg film-coated tablets
Duloxetine hydrochlorideInitial report12.02.2026OtherDuloxetine Aurobindo 60 mg gastro-resistant hard capsules
Venlafaxine hydrochlorideInitial report12.02.2026Production problemVenlafaxine Aurobindo 75 mg hard capsule, delayed release
Dutasteride; tamsulosin hydrochlorideInitial report12.02.2026Production problemDutasteride/tamsulosin PUREN 0.5 mg/0.4 mg hard capsules
Deferoxamine mesylateInitial report12.02.2026Production problemDeferoxamine mesylate 2 g powder for solution for injection or infusion
Amiodarone hydrochlorideInitial report12.02.2026Production problemAmiodarone Aurobindo 200 mg tablets
Paliperidone palmitateChange notification12.02.2026OtherPaliperidone AL 25 mg depot injection suspension in a pre-filled syringe
Dexamethasone acetate (Ph.Eur.); lidocaine hydrochloride monohydrateInitial report11.02.2026Production problemSupertendin 5
Dexamethasone acetate (Ph.Eur.); lidocaine hydrochloride monohydrateInitial report11.02.2026Production problemSupertendin 10
Lidocaine hydrochloride monohydrateChange notification10.02.2026OtherXylocaine Gel 2%
EstriolInitial report10.02.2026OtherOvestin 1 mg tablets
Sertraline hydrochlorideChange notification10.02.2026Production problemSertraline-neuraxpharm 200 mg film-coated tablets
Sertraline hydrochlorideChange notification10.02.2026Production problemSertraline-neuraxpharm 150 mg film-coated tablets
LevetiracetamChange notification10.02.2026Production problemLevetiracetam Holsten 750 mg film-coated tablets
Human insulin ((with manufacturing details))Initial report09.02.2026OtherHuminsulin Basal (NPH) 100 100 IU/ml injection suspension in vial
Thioctic acid trometamol salt (1:1)Change notification09.02.2026OtherThioctacid 600 T
Prednisolone acetateChange notification09.02.2026Production problemPrednifluid 10 mg/ml eye drop suspension
Terazosin hydrochloride dihydrateChange notification09.02.2026OtherHeitrin 5 mg
Terazosin hydrochloride dihydrateChange notification09.02.2026OtherHeitrin 1mg
Terazosin hydrochloride dihydrateChange notification09.02.2026OtherHeitrin 2 mg
DapsonInitial report09.02.2026OtherDapsone Zentiva 50 mg tablets
Mometasone furoate (Ph.Eur.)Change notification09.02.2026Production problemMomecutan solution
IsoniazidChange notification09.02.2026OtherIsozid 50 mg
Rifampicin sodiumChange notification09.02.2026OtherEremfat i.v. 600mg
2026年2月16日
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