BfArMボトルネック・レポート（2025年7月14日～7月20日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
OlanzapineInitial report18.07.2025Production problemZyprexa 7.5 mg coated tablets – OP70 (blister pack)
Olanzapine embonate monohydrateInitial report18.07.2025Production problemZYPADHERA 405 mg powder and solvent for the preparation of a depot injection suspension – OP(931mg+3ml)
Olanzapine embonate monohydrateChange notification18.07.2025Production problemZYPADHERA 300 mg powder and solvent for the preparation of a depot injection suspension – OP(690mg+3ml)
LevetiracetamInitial report18.07.2025OtherLevetiracetam UCB
Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y)Change notification18.07.2025OtherFerrlecit 62.5 mg
Zoledronic acid monohydrateChange notification17.07.2025Production problemZoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion – OP[4x(4x5ml)]
Zoledronic acid monohydrateChange notification17.07.2025Production problemZoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion – OP5ml
Paliperidone palmitateChange notification17.07.2025OtherPaliperidone AL 25 mg depot injection suspension in a pre-filled syringe
Tacrolimus monohydrateChange notification17.07.2025OtherTacrolimus AL 3 mg hard capsules, delayed release
Epoetin betaInitial report17.07.2025OtherNeoRecormon 4000 IU injection solution in pre-filled syringe – OP6
Duloxetine hydrochlorideChange notification17.07.2025Production problemDuloxetine PUREN 40 mg gastro-resistant hard capsules
CarbamazepineInitial report17.07.2025OtherCarbadura 400 mg retard
TobramycinInitial report17.07.2025Production problemTOBI Podhaler 28 mg hard capsules with powder for inhalation – OP224(4×56)
EtoposideChange notification16.07.2025Production problemEto-Gry 20 mg/ml concentrate for solution for infusion
Amantadine hemisulfateChange notification16.07.2025OtherPK-Merz Infusion
Clopidogrel besylateInitial report16.07.2025OtherClopidogrel Denk 75 mg film-coated tablets
Amlodipine besylate; perindopril tert-butylamineInitial report16.07.2025OtherPerindopril/amlodipine Denk 8 mg/10 mg tablets
Amlodipine besylate; perindopril tert-butylamineInitial report16.07.2025OtherPerindopril/amlodipine Denk 4 mg/10 mg tablets
Amlodipine besylate; perindopril tert-butylamineInitial report16.07.2025OtherPerindopril/amlodipine Denk 4 mg/5 mg tablets
Methylphenidate hydrochlorideChange notification16.07.2025OtherMethylphenidate AL 18 mg prolonged-release tablets
Methylphenidate hydrochlorideChange notification16.07.2025OtherMethylphenidate AL 27 mg prolonged-release tablets
Initial report16.07.2025Production problemTeceos
Methylphenidate hydrochlorideChange notification15.07.2025OtherMETHYLPHENI TAD 20 mg tablets
Methylphenidate hydrochlorideChange notification15.07.2025OtherMETHYLPHENI TAD 5 mg tablets
Methylphenidate hydrochlorideChange notification15.07.2025OtherMETHYLPHENI TAD 10 mg tablets
SemaglutideChange notification15.07.2025OtherOzempic 1 mg injection solution in a pre-filled pen – OP(3x3ml)
RifampicinInitial report15.07.2025Production problemEREMFAT 450 mg
Methyldopa (Ph.Eur.)Initial report15.07.2025OtherDopegyt tablets
AprepitantChange notification15.07.2025Production problemAprepitant beta 125 mg and 80 mg hard capsules
Atomoxetine hydrochlorideChange notification15.07.2025Production problemAtomoxetine beta 80 mg hard capsules
Olanzapine embonate monohydrateChange notification15.07.2025Production problemZYPADHERA 210 mg powder and solvent for the preparation of a depot injection suspension – OP(483mg+3ml)
Cinacalcet hydrochlorideChange notification15.07.2025OtherCinacalcet Mylan 60 mg film-coated tablets – OP(28×1)
Trandolapril; verapamil hydrochlorideChange notification15.07.2025OtherTarka 180 mg/ 2 mg modified-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification15.07.2025OtherSeroquel Prolong 50 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification15.07.2025OtherSeroquel Prolong 300 mg prolonged-release tablets
Norepinephrine hydrochloride/noradrenaline hydrochlorideChange notification14.07.2025Production problemArterenol 1 ml
Epinephrine hydrochlorideChange notification14.07.2025Production problemSuprarenin ampoules
Sodium iodide ((123)I)Initial report14.07.2025OtherSodium iodide (I 123) injection DRN 5375
Iobenguan ((123)I)Initial report14.07.2025OtherMIBG (I123) injection DRN 5379
Quetiapine fumarate (Ph.Eur.)Initial report14.07.2025Production problemQuetiapine Accord 300 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Initial report14.07.2025Production problemQuetiapine Accord 50 mg prolonged-release tablets
Midodrine hydrochlorideChange notification14.07.2025OtherGutron tablets
Insulin lisproInitial report14.07.2025OtherHumalog Mix25 KwikPen 100 E/ml injection suspension – OP (5x3ml)
CarbamazepineInitial report14.07.2025OtherCarbamazepine-ratiopharm 400 mg prolonged-release tablets
CarbamazepineInitial report14.07.2025OtherCarbamazepine-ratiopharm 200 mg prolonged-release tablets
Flucloxacillin sodium 1 H<2>OChange notification14.07.2025Production problemStaphylex 250 mg capsules
Sodium (methylprednisolone-21-succinate)Change notification14.07.2025OtherUrbason solubile forte 1000 mg
2025年7月21日
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