BfArMボトルネック・レポート（2025年10月27日～11月2日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
NimodipineChange notification31.10.2025OtherNimotop S
Galantamine hydrobromideChange notification31.10.2025OtherGalantamine – 1A Pharma 24 mg delayed-release hard capsules
NimodipineInitial report31.10.2025OtherNimotop
Galantamine hydrobromideChange notification31.10.2025OtherGalantamine – 1A Pharma 16 mg delayed-release hard capsules
Sertraline hydrochlorideInitial report31.10.2025OtherZoloft 20 mg/ml concentrate for oral solution
Ciprofloxacin hydrochloride monohydrateChange notification30.10.2025OtherCIPRO BASICS 750 mg film-coated tablets
Ciprofloxacin hydrochloride monohydrateChange notification30.10.2025OtherCIPRO BASICS 250 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification30.10.2025OtherATORVASTATIN BASICS 80 mg film-coated tablets
Ezetimibe; simvastatinChange notification30.10.2025Production problemEZETIMIB/SIMVA BASICS 10 mg/80 mg tablets
Ezetimibe; simvastatinChange notification30.10.2025Production problemEZETIMIB/SIMVA BASICS 10 mg/40 mg tablets
Ezetimibe; simvastatinChange notification30.10.2025Production problemEZETIMIB/SIMVA BASICS 10 mg/20 mg tablets
Ezetimibe; simvastatinChange notification30.10.2025Production problemEZETIMIBE/SIMVA BASICS 10 mg/10 mg tablets
Esomeprazole hemimagnesiumChange notification30.10.2025Production problemESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsules
Esomeprazole hemimagnesiumChange notification30.10.2025Production problemESOMEPRAZOLE BASICS 40 mg gastro-resistant hard capsules
IsotretinoinChange notification30.10.2025OtherISOTRETINOIN BASICS 10 mg soft capsules
Isophan insulin suspension for injection (Ph.Eur.)Initial report30.10.2025OtherProtaphane Penfill 100 IU/ml injection suspension in cylinder ampoule – OP(10x3ml)
Flecainide acetateChange notification30.10.2025OtherTambocor
Moxifloxacin hydrochloride (Ph.Eur.) ((with information on water content (1:x)))Change notification30.10.2025OtherMoxifloxacin Holsten 400 mg film-coated tablets
Doxepin hydrochloride (Ph.Eur.)Initial report30.10.2025OtherDoxepin 50 Holsten
AlprazolamChange notification30.10.2025OtherAlprazolam – 1 A Pharma 1 mg tablets
OxcarbazepineChange notification30.10.2025OtherOxcarbazepine – 1 A Pharma 60 mg/ml oral suspension
FlutamideChange notification30.10.2025Production problemFLUTA-cell 250 mg tablets
VoriconazoleInitial report29.10.2025OtherVFEND 200 mg film-coated tablets
Doxepin hydrochloride (Ph.Eur.)Change notification29.10.2025OtherDoxepin 75 Holsten
Doxepin hydrochloride (Ph.Eur.)Change notification29.10.2025Production problemDoxepin 25 Holsten
Methylphenidate hydrochlorideChange notification29.10.2025OtherMethylphenidate AL 36 mg prolonged-release tablets
Methylphenidate hydrochlorideChange notification29.10.2025OtherMetiphenal 10 mg modified-release hard capsules
PosaconazoleChange notification29.10.2025OtherPosaconazole AL 40 mg/ml oral suspension
Methylphenidate hydrochlorideChange notification29.10.2025OtherMethylphenidate AL 27 mg prolonged-release tablets
AprepitantChange notification29.10.2025OtherAprepitant AL 80 mg hard capsules
Levothyroxine sodiumChange notification28.10.2025Production problemL-thyroxine Henning 125
(4′-O-(13)C)MethacetinChange notification28.10.2025Production problemLiMAxetin 4 mg/ml solution for injection
BesilesomabInitial report28.10.2025Production problemScintimun
BesilesomabInitial report28.10.2025Production problemScintimun
LevetiracetamChange notification28.10.2025OtherLevetiracetam – 1 A Pharma 1500 mg film-coated tablets
Olanzapine embonate monohydrateInitial report28.10.2025Production problemZYPADHERA 210 mg powder and solvent for the preparation of a prolonged-release suspension for injection – OP(483mg+3ml)
Paliperidone palmitateInitial report28.10.2025OtherPaliperidone AL 25 mg prolonged-release injection suspension in a pre-filled syringe
Paliperidone palmitateChange notification28.10.2025OtherPaliperidone AL 50 mg depot injection suspension in a pre-filled syringe
OlanzapineChange notification28.10.2025Production problemZYPREXA
Fluphenazine decanoateChange notification28.10.2025Production problemFluphenazine-neuraxpharm D 50 mg/0.5 ml
Fluphenazine decanoateChange notification28.10.2025Production problemFluphenazine-neuraxpharm D 12.5 mg/0.5 ml
Fluphenazine decanoateChange notification28.10.2025Production problemFluphenazine-neuraxpharm D 25 mg/ml
Fluphenazine decanoateChange notification28.10.2025Production problemFluphenazine-neuraxpharm D 100 mg/ml
Atomoxetine hydrochlorideChange notification28.10.2025Production problemAtomoxetine-neuraxpharm 60 mg hard capsules
Atomoxetine hydrochlorideChange notification28.10.2025Production problemAtomoxetine-neuraxpharm 10 mg hard capsules
Atomoxetine hydrochlorideChange notification28.10.2025Production problemAtomoxetine-neuraxpharm 18 mg hard capsules
Atomoxetine hydrochlorideChange notification28.10.2025Production problemAtomoxetine-neuraxpharm 25 mg hard capsules
Atomoxetine hydrochlorideChange notification28.10.2025Production problemAtomoxetine-neuraxpharm 40 mg hard capsules
Atomoxetine hydrochlorideChange notification28.10.2025Production problemAtomoxetine-neuraxpharm 80 mg hard capsules
Atomoxetine hydrochlorideChange notification28.10.2025Production problemAtomoxetine-neuraxpharm 100 mg hard capsules
Haloperidol decanoateChange notification28.10.2025Production problemHaloperidol-neuraxpharm decanoate 50 mg/ml
Haloperidol decanoateChange notification28.10.2025Production problemHaloperidol-neuraxpharm decanoate 100 mg/ml
Quetiapine fumarate (Ph.Eur.)Change notification28.10.2025OtherQuetiapine-neuraxpharm 50 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification28.10.2025OtherQuetiapine-neuraxpharm 150 mg prolonged-release tablets
FlutamideChange notification28.10.2025OtherFlutamide AL 250
Quetiapine fumarate (Ph.Eur.)Change notification28.10.2025OtherQuetiapine-neuraxpharm 200 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification28.10.2025OtherQuetiapine-neuraxpharm 300 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification28.10.2025OtherQuetiapine-neuraxpharm 400 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification28.10.2025OtherQuetiapine-neuraxpharm 600 mg prolonged-release tablets
Biperiden hydrochlorideChange notification28.10.2025Production problemBiperiden-neuraxpharm 2 mg
Biperiden hydrochlorideChange notification28.10.2025Production problemBiperiden-neuraxpharm 4 mg
Methylphenidate hydrochlorideChange notification28.10.2025OtherMethylphenidate hydrochloride-neuraxpharm 27 mg prolonged-release tablets
Sodium (methylprednisolone-21-succinate)Change notification28.10.2025OtherUrbason soluble forte 1000 mg
Isosorbide mononitrateChange notification28.10.2025Production problemISMN STADA 50 mg hard capsules, delayed release
AprepitantChange notification28.10.2025Production problemAprepitant STADA 125 mg and 80 mg hard capsules
Pramipexole dihydrochloride monohydrateChange notification28.10.2025Production problemPramipexole STADA 0.52 mg prolonged-release tablets
AprepitantChange notification28.10.2025Production problemAprepitant STADA 80 mg hard capsules
AprepitantChange notification28.10.2025Production problemAprepitant STADA 125 mg hard capsules
GabapentinChange notification27.10.2025OtherGabapentin Holsten 100 mg hard capsules
TetrabenazineInitial report27.10.2025OtherTetrabenazine Aristo 25 mg tablets
Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y)Change notification27.10.2025OtherFerrlecit 62.5 mg
Cefaclor monohydrateChange notification27.10.2025OtherCefaclor 125 TS – 1 A Pharma
Methyldopa (Ph.Eur.)Change notification27.10.2025OtherDopegyt tablets
Insulin glargineChange notification27.10.2025OtherSemglee 100 units/ml solution for injection in pre-filled pen – OP(5x3ml)
Sufentanil citrateInitial report27.10.2025Production problemSufenta mite
Arsenic(III) oxideChange notification27.10.2025Production problemArsenic trioxide STADA 1 mg/ml concentrate for solution for infusion
2025年11月3日
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