BfArMボトルネック・レポート（2025年11月17日～11月23日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
Levothyroxine sodiumInitial report21.11.2025Production problemL-thyroxine Aventis 150 microgram tablets
Levothyroxine sodiumChange notification21.11.2025Production problemL-Thyroxine Henning 50
Sevelamer carbonateChange notification21.11.2025OtherRenvela 0.8 g powder for oral suspension – OP(90×842.32mg)
Rizatriptan benzoateChange notification21.11.2025Production problemRizatriptan Glenmark 5 mg orodispersible tablets
Moxifloxacin hydrochloride (Ph.Eur.) ((with information on water content (1:x)))Initial report20.11.2025OtherMoxifloxacin Micro Labs 400 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification20.11.2025OtherAtorvastatin Micro Labs 60 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Initial report20.11.2025OtherAtorvastatin Micro Labs 40 mg film-coated tablets
SunitinibInitial report20.11.2025OtherSunitinib AL 37.5 mg hard capsules
SunitinibInitial report20.11.2025OtherSunitinib AL 12.5 mg hard capsules
Atorvastatin calcium trihydrate (Ph.Eur.)Initial report20.11.2025OtherAtorvastatin Micro Labs 30 mg film-coated tablets
IsoniazidInitial report20.11.2025OtherIsozid 100 mg
DiazepamInitial report20.11.2025OtherDiazepam-ratiopharm 10 mg/2 ml solution for injection
Rifampicin sodiumInitial report20.11.2025OtherEremfat i.v. 300mg
AlprazolamInitial report20.11.2025OtherAlprazolam AbZ 0.5 mg tablets
AlprazolamInitial report20.11.2025OtherAlprazolam-ratiopharm 0.5 mg tablets
Trandolapril; verapamil hydrochlorideChange notification20.11.2025OtherTarka 180 mg/2 mg modified-release tablets
Morphine hemisulfate 2.5 hydrateInitial report19.11.2025Production problemSubstitol 30 mg hard capsules, delayed release
Hydromorphone hydrochlorideChange notification19.11.2025Production problemPalladon injection 2 mg
AprepitantChange notification19.11.2025OtherAprepitant AL 125 mg and 80 mg hard capsules
Quetiapine fumarate (Ph.Eur.)Change notification19.11.2025OtherQuetiapine AL 300 mg film-coated tablets
Beclomethasone dipropionate (Ph.Eur.)Change notification19.11.2025OtherBeclorhinol aquosum 50 micrograms
NitrendipineChange notification19.11.2025OtherNitrendipine AL 20
Vinflunine bis[(R,R)-tartrate]Change notification18.11.2025Production problemJavlor 25 mg/ml concentrate for solution for infusion – OP(1x2ml)
ChlortalidoneChange notification18.11.2025OtherChlortalidone HEXAL 12.5 mg tablets
Calcium trisodium pentetate (with information on water content, if applicable)Change notification18.11.2025OtherTechnescan DTPA
Medium-chain triglycerides; omega-3 acid triglycerides (with information on origin and/or composition); refined soybean oil (Ph.Eur.)Change notification18.11.2025Production problemLipidem Emulsion for infusion
AprepitantChange notification18.11.2025Production problemAprepitant STADA 125 mg and 80 mg hard capsules
AprepitantChange notification18.11.2025Production problemAprepitant STADA 80 mg hard capsules
AprepitantChange notification18.11.2025Production problemAprepitant STADA 125 mg hard capsules
MisoprostolChange notification17.11.2025OtherAngusta 25 microgram tablets
Insulin glargineInitial report17.11.2025OtherABASAGLAR 100 IU/ml solution for injection in pre-filled pen – OP (5x3ml)
PosaconazoleChange notification17.11.2025OtherPosaconazole HEXAL 40 mg/ml oral suspension
Lidocaine hydrochloride monohydrateChange notification17.11.2025OtherXylocaine Gel 2%
Vancomycin hydrochlorideChange notification17.11.2025OtherVancomycin “Lederle” 1000mg
2025年11月24日
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