BfArMボトルネック・レポート（2月16日～2月22日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
Acetylcholine chlorideChange notification20.02.2026Production problemMiochol-E powder and solvent for the preparation of an instillation solution for intraocular use
Sodium (methylprednisolone-21-succinate)Change notification19.02.2026OtherUrbason solubile forte 1000 mg
Beclomethasone dipropionate (Ph.Eur.)Initial report19.02.2026Production problemJunik metered dose inhaler 100 micrograms
Quetiapine fumarate (Ph.Eur.)Change notification19.02.2026OtherSeroquel Prolong 300 mg prolonged-release tablets
Beclomethasone dipropionate (Ph.Eur.)Initial report19.02.2026Production problemJunik Autohaler 100 micrograms
Acetylcysteine; alanine; arginine; acetic acid 99%; glycine; histidine; isoleucine; leucine; lysine acetate; methionine; phenylalanine; proline; serine; threonine; tryptophan; valineInitial report19.02.2026Production problemAminosteril N-Hepa 8%
Amidotrizoate meglumine; sodium amidotrizoateInitial report19.02.2026OtherGastrografin
Salbutamol sulfateChange notification19.02.2026OtherBronchospray Autohaler
Isosorbide mononitrateChange notification19.02.2026Production problemISMN STADA 50 mg hard capsules, delayed release
Isosorbide mononitrateChange notification19.02.2026Production problemISMN STADA 20 mg tablets
AprepitantChange notification19.02.2026Production problemAprepitant STADA 125 mg and 80 mg hard capsules
AprepitantChange notification19.02.2026Production problemAprepitant STADA 80 mg hard capsules
Atomoxetine hydrochlorideChange notification19.02.2026OtherAtomoxetine PUREN 10 mg hard capsules
Escitalopram oxalateInitial report19.02.2026OtherEscitalopram Aurobindo 20 mg film-coated tablets
NitrendipineChange notification19.02.2026OtherNitrendipine AbZ 10 mg tablets
Clonidine hydrochlorideChange notification19.02.2026OtherClonidine-ratiopharm 300
Clonidine hydrochlorideChange notification19.02.2026OtherClonidine-ratiopharm 150
Clonidine hydrochlorideChange notification19.02.2026OtherClonidine-ratiopharm 75
Pantoprazole sodium sesquihydrateInitial report19.02.2026OtherPantoprazole Denk 40 mg gastro-resistant tablets
AlprazolamChange notification19.02.2026OtherAlprazolam-ratiopharm 1.0 mg tablets
Quetiapine fumarate (Ph.Eur.)Change notification19.02.2026OtherQuetiapine-ratiopharm 300 mg prolonged-release tablets
Propranolol hydrochlorideChange notification19.02.2026OtherPropra-ratiopharm 80 mg film-coated tablets
Propranolol hydrochlorideChange notification19.02.2026OtherPropra-ratiopharm 40 mg film-coated tablets
Colistimethate sodiumChange notification19.02.2026Production problemColistin CF
Ipratropium bromide (Ph.Eur.)Change notification19.02.2026Production problemIpratropium Teva 250 micrograms/1 ml solution for nebulizer
AprepitantChange notification19.02.2026Production problemAprepitant STADA 125 mg hard capsules
AciclovirInitial report19.02.2026Production problemAciclovir AbZ Cold sore cream
AciclovirInitial report19.02.2026Production problemAciclovir-ratiopharm 50 mg/g cream
OxytocinChange notification19.02.2026Production problemOxytocin 3 I.E. Hexal
Pramipexole dihydrochloride monohydrateChange notification19.02.2026OtherPramipexole – 1 A Pharma 0.26 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification19.02.2026Production problemQuetiapine HEXAL 150 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification19.02.2026Production problemQuetiapine – 1 A Pharma 150 mg prolonged-release tablets
Thioctic acid trometamol salt (1:1)Change notification19.02.2026OtherThioctacid 600 T
Quetiapine fumarate (Ph.Eur.)Change notification19.02.2026Production problemQuetiapine – 1 A Pharma 50 mg prolonged-release tablets
Methyldopa (Ph.Eur.)Change notification18.02.2026Production problemMethyldopa STADA 250 mg film-coated tablet
Atorvastatin calcium trihydrate (Ph.Eur.)Initial report18.02.2026OtherAtorvastatin Micro Labs 80 mg film-coated tablets
Von Willebrand factorChange notification18.02.2026OtherWILLFACT 1000 IU
PrimidoneChange notification17.02.2026OtherPrimidone Holsten
MethylprednisoloneInitial report17.02.2026OtherMethylprednisolone 8 mg JENAPHARM
Sitagliptin hydrochloride monohydrateInitial report17.02.2026OtherSitagliptin PUREN 50 mg film-coated tablets
MirtazapineInitial report17.02.2026OtherMirtazapine Aurobindo 30 mg film-coated tablets
LevetiracetamInitial report17.02.2026OtherLevetiracetam Aurobindo 750 mg film-coated tablets
Tamsulosin hydrochlorideInitial report17.02.2026OtherTamsulosin Aurobindo 0.4 mg prolonged-release capsules
Methylphenidate hydrochlorideChange notification17.02.2026OtherMethylphenidate hydrochloride-neuraxpharm 27 mg prolonged-release tablets
Tamsulosin hydrochlorideChange notification17.02.2026OtherTamsulosin hydrochloride PUREN 0.4 mg prolonged-release capsules
UrapidilInitial report17.02.2026Production problemUrapidil PUREN 90 mg prolonged-release capsules
TeriflunomideInitial report17.02.2026Production problemTeriflunomide PUREN 14 mg film-coated tablets
Trandolapril; verapamil hydrochlorideChange notification17.02.2026OtherTarka 180 mg/2 mg modified-release tablets
Fluoxetine hydrochlorideChange notification16.02.2026OtherFluoxetine Micro Labs 30 mg hard capsules
Fluoxetine hydrochlorideChange notification16.02.2026OtherFluoxetine Micro Labs 60 mg hard capsules
Methylphenidate hydrochlorideChange notification16.02.2026OtherMETHYLPHENIDATE 5 mg tablets
LacosamideInitial report16.02.2026OtherVimpat 100 mg film-coated tablets – OP14
LorazepamChange notification16.02.2026OtherTavor 2.5 mg Expidet
Terazosin hydrochloride dihydrateChange notification16.02.2026OtherHeitrin 2 mg
Terazosin hydrochloride dihydrateChange notification16.02.2026OtherHeitrin 1 mg
Terazosin hydrochloride dihydrateChange notification16.02.2026OtherHeitrin 5mg
RitonavirInitial report16.02.2026OtherRitonavir Viatris 100 mg film-coated tablets – OP30
FlurazepamInitial report16.02.2026Production problemFlurazepam real
2026年2月23日
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