BfArMボトルネック・レポート(2025年8月18日~8月24日)

Active ingredients
Report type
Date of last messageType of reasonAM designation
Midodrine hydrochlorideChange notification22.08.2025OtherGutron tablets
Beclometasone dipropionate (Ph.Eur.)Initial21.08.2025OtherBeclorhinol aquosum 50 micrograms
Calcium acetate hydrate ((with information on water content (1:x)))Change notification21.08.2025Production problemRenacet 950 mg
GabapentinInitial21.08.2025OtherGabapentin Holsten 300 mg hard capsules
GabapentinInitial21.08.2025Production problemGabapentin Holsten 600 mg film-coated tablets
CarbamazepineChange notification21.08.2025OtherCarbadura 400 mg retard
Insulin aspartChange notification21.08.2025OtherNovoRapid PumpCart 100 E/ml solution for injection in cartridge – OP[5x(5×1.6ml)]
Methylphenidate hydrochlorideInitial21.08.2025OtherMethylphenidate hydrochloride – Neuraxpharm 18 mg prolonged-release tablets
Human insulin (with manufacturing details); isophane insulin suspension for injection (Ph.Eur.)Change notification21.08.2025OtherActraphane 30 FlexPen 100 IU/ml injection suspension in injector – OP(10x3ml)
Biperiden hydrochlorideChange notification21.08.2025Production problemBiperiden-neuraxpharm 4 mg
Biperiden hydrochlorideChange notification21.08.2025Production problemBiperiden-neuraxpharm 2 mg
Trimipramine mesylateChange notification20.08.2025OtherTrimipramine – 1 A Pharma 40 mg/ml oral drops, solution
Hydromorphone hydrochlorideChange notification20.08.2025OtherHydromorphone-HEXAL 2.6 mg hard capsules
Zoledronic acid monohydrateChange notification20.08.2025Production problemZoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion – OP[4x(4x5ml)]
Zoledronic acid monohydrateChange notification20.08.2025Production problemZoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion – OP5ml
Methylphenidate hydrochlorideChange notification19.08.2025OtherMethylphenidate AL 18 mg prolonged-release tablets
Paliperidone palmitateChange notification19.08.2025OtherPaliperidone AL 150 mg depot injection suspension in a pre-filled syringe
Ketotifen fumarateInitial19.08.2025Production problemKetotifen STADA 1 mg hard capsules
Quetiapine fumarate (Ph.Eur.)Change notification19.08.2025OtherSeroquel Prolong 50 mg prolonged-release tablets
Methylphenidate hydrochlorideChange notification19.08.2025OtherMETHYLPHENI TAD 10 mg tablets
Vincristine sulfateChange notification19.08.2025Production problemVincristine sulfate-TEVA 1 mg/ml injection solution
Phenytoin sodiumInitial19.08.2025Production problemPhenhydan injection solution
Quetiapine fumarate (Ph.Eur.)Change notification19.08.2025OtherSeroquel Prolong 300 mg prolonged-release tablets
Phenylephrine hydrochlorideInitial19.08.2025Production problemNeosynephrine POS 5%
Olanzapine embonate monohydrateChange notification18.08.2025Production problemZYPADHERA 210 mg powder and solvent for the preparation of a depot injection suspension – OP(483mg+3ml)
OlanzapineChange notification18.08.2025Production problemZyprexa 7.5 mg coated tablets – OP70 (blister pack)
Olanzapine embonate monohydrateChange notification18.08.2025Production problemZYPADHERA 300 mg powder and solvent for the preparation of a depot injection suspension – OP(690mg+3ml)
Norepinephrine hydrochloride/noradrenaline hydrochlorideChange notification18.08.2025Production problemArterenol 1 ml
BaclofenInitial18.08.2025OtherLioresal Intrathecal 0.05 mg/1 ml solution for injection
PrimidoneInitial18.08.2025Production problemMylepsinum
2025年8月25日
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