BfArMボトルネック・レポート（2025年9月8日～9月14日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
Hydrated dihydralazine sulfate (Ph.Eur.)Initial report12.09.2025Production problemNepresol
Doxepin hydrochloride (Ph.Eur.)Change notification12.09.2025Production problemDoxepin 75 Holsten
Prednisolone acetateChange notification12.09.2025Production problemPredni-Ophtal Gel
Indapamide; Perindopril arginineInitial report12.09.2025OtherPerindopril arginine/indapamide Viatris 5 mg/1.25 mg film-coated tablets
Indapamide; Perindopril tert-butylamineInitial report12.09.2025OtherPerindopril-dura plus 2 mg/0.625 mg tablets
Amantadine hemisulfateChange notification12.09.2025OtherPK-Merz Infusion
TrandolaprilInitial report12.09.2025OtherUdrik 0.5 mg
Rosuvastatin calcium (Ph.Eur.)Initial report11.09.2025OtherRosuvastatin Aurobindo 20 mg film-coated tablets
Atomoxetine hydrochlorideInitial report11.09.2025OtherAtomoxetine PUREN 10 mg hard capsules
Atomoxetine hydrochlorideInitial report11.09.2025Production problemAtomoxetine PUREN 80 mg hard capsules
Amlodipine besylate; telmisartanInitial report11.09.2025Production problemTWYNSTA 80 mg/10 mg tablets – OP98
Amlodipine besylate; telmisartanInitial report11.09.2025Production problemTWYNSTA 40 mg/5 mg tablets – OP98
Terazosin hydrochloride dihydrateChange notification11.09.2025OtherHeitrin 2mg
Terazosin hydrochloride dihydrateChange notification11.09.2025OtherHeitrin 5mg
Terazosin hydrochloride dihydrateChange notification11.09.2025OtherHeitrin 1 mg
OxazepamChange notification11.09.2025OtherOxazepam AL 10
Paliperidone palmitateChange notification11.09.2025OtherPaliperidone AL 25 mg Depot injection suspension in a pre-filled syringe
Azithromycin dihydrateChange notification11.09.2025OtherAzithromycin AL 250 mg film-coated tablets
Hydromorphone hydrochlorideChange notification11.09.2025OtherHydromorphone PAINBREAK 4 mg prolonged-release tablets
Hydromorphone hydrochlorideChange notification11.09.2025OtherHydromorphone PAINBREAK 8 mg prolonged-release tablets
Dexketoprofen trometamolChange notification10.09.2025Production problemSympal inject 50 mg solution for injection/infusion
AdenosineInitial report09.09.2025Production problemAdenosine Altamedics 3 mg/ml solution for injection
ImiquimodInitial report09.09.2025Production problemAldara 5% cream – OP24
Atorvastatin calcium trihydrate (Ph.Eur.)Initial report09.09.2025OtherSortis 20 mg chewable tablets
VerteporfinChange notification09.09.2025OtherVisudyne 15 mg powder for solution for infusion – OP1
Clonidine hydrochlorideInitial report09.09.2025OtherClonidine-ratiopharm 300
Clonidine hydrochlorideInitial report09.09.2025OtherClonidine-ratiopharm 150
Clonidine hydrochlorideInitial report09.09.2025OtherClonidine-ratiopharm 75
Methylphenidate hydrochlorideChange notification09.09.2025OtherMethylphenidate-ratiopharm 40 mg hard capsules with modified release
Methylphenidate hydrochlorideChange notification09.09.2025OtherMethylphenidate-ratiopharm 20 mg hard capsules with modified release
Methylphenidate hydrochlorideInitial report09.09.2025OtherMethylphenidate-ratiopharm 30 mg hard capsules with modified release
Methylphenidate hydrochlorideInitial report09.09.2025OtherMethylphenidate-ratiopharm 10 mg modified-release hard capsules
DuloxetineInitial report09.09.2025OtherDuloxetine Mylan 30 mg gastro-resistant hard capsules – OP100(Fl)
DuloxetineInitial report09.09.2025OtherDuloxetine Mylan 60 mg gastro-resistant hard capsules – OP100(Fl)
Procaine hydrochlorideChange notification09.09.2025OtherProcaine 2% JENAPHARM
Procaine hydrochlorideChange notification09.09.2025OtherProcaine 1% JENAPHARM
Pramipexole dihydrochloride monohydrateChange notification08.09.2025OtherPramipexole – 1 A Pharma 0.52 mg prolonged-release tablets
Sodium mycophenolateChange notification08.09.2025OtherMycophenolic acid HEXAL 360 mg gastro-resistant tablets
Atomoxetine hydrochlorideChange notification08.09.2025Production problemAtomoxetine beta 18 mg hard capsules
Atomoxetine hydrochlorideChange notification08.09.2025Production problemAtomoxetine beta 100 mg hard capsules
Naloxone hydrochloride dihydrate; oxycodone hydrochloride (Ph.Eur.)Initial report08.09.2025Production problemOxycodone/naloxone Krugmann 40 mg/20 mg prolonged-release tablets
Naloxone hydrochloride dihydrate; oxycodone hydrochloride (Ph.Eur.)Initial report08.09.2025Production problemOxycodone / Naloxone Krugmann 20 mg/10 mg prolonged-release tablets
Oxycodone hydrochloride (Ph.Eur.)Change notification08.09.2025Production problemOxygesic 5 mg
Rosuvastatin HemicalciumChange notification08.09.2025OtherROSUVASTATIN-ELPEN 40 mg film-coated tablets
Rosuvastatin HemicalciumChange notification08.09.2025OtherROSUVASTATIN-ELPEN 20 mg film-coated tablets
Rosuvastatin HemicalciumChange notification08.09.2025OtherROSUVASTATIN-ELPEN 10 mg film-coated tablets
Rosuvastatin HemicalciumChange notification08.09.2025OtherROSUVASTATIN-ELPEN 5 mg film-coated tablets
Hydromorphone hydrochlorideInitial report08.09.2025Production problemPalladon inject 20 mg/ml solution for injection/infusion
Hydromorphone hydrochlorideInitial report08.09.2025Production problemPalladon 2.6 mg hard capsules
Oxycodone hydrochloride (Ph.Eur.)Change notification08.09.2025OtherOxygesic 5 mg
Oxycodone hydrochlorideChange notification08.09.2025OtherOXYGESIC 10 mg
Sugammadex sodiumChange notification08.09.2025Production problemSugammadex Amomed
2025年9月15日
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