BfArMボトルネック・レポート（1月5日～1月11日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
Human fibrinogenChange notification11.01.2026OtherFibCLOT
Trimipramine mesylateChange notification09.01.2026OtherTrimipramine – 1 A Pharma 40 mg/ml oral drops, solution
Etoposide phosphateInitial report09.01.2026Production problemEtopophos 1000 mg, powder for solution for infusion
VandetanibInitial report09.01.2026OtherCaprelsa 300 mg film-coated tablets – OP30
Phenobarbital sodiumInitial report09.01.2026OtherLuminal solution for injection
LevetiracetamInitial report09.01.2026OtherKeppra 100 mg/ml oral solution – OP (1x150ml)
Morphine hemisulfate 2.5 hydrateInitial report09.01.2026Production problemSubstitol 60 mg hard capsule, delayed release
Erythromycin lactobionateInitial report09.01.2026Production problemErythromycin Inresa i.v. 1g
Lidocaine hydrochloride monohydrateChange notification09.01.2026OtherXylocaine Gel 2%
Mometasone furoate (Ph.Eur.)Initial report09.01.2026Production problemMomecutan solution
Insulin aspartInitial report09.01.2026OtherNovoRapid 100 E/ml solution for injection in vial – OP[5x(1x10ml)]
Pramipexole dihydrochloride monohydrateChange notification09.01.2026OtherPramipexole – 1 A Pharma 0.26 mg prolonged-release tablets
AprepitantChange notification09.01.2026OtherEMEND 125 mg powder for oral suspension – OPXXXXmg
OxytocinChange notification09.01.2026Production problemOxytocin 3 IU Hexal
Metamizole sodium monohydrateChange notification09.01.2026Production problemNovaminsulfon – 1 A Pharma Drops
DigoxinChange notification08.01.2026Production problemLanicor
MethylprednisoloneChange notification08.01.2026Production problemUrbason 16 mg tablets
(RS)-2,3-Bis(sulfanyl)propane-1-sulfonic acid sodium salt monohydrateInitial report08.01.2026Production problemDimaval
Epoetin thetaInitial report08.01.2026OtherEporatio 5000 IU/0.5 ml injection solution in pre-filled syringe – OP (6×0.5 ml)
Insulin aspartChange notification08.01.2026OtherKirsty 100 units/ml solution for injection in a pre-filled pen
Insulin aspartChange notification08.01.2026OtherKirsty 100 units/ml solution for injection in a pre-filled pen
Doxycycline monohydrateInitial report08.01.2026OtherDoxycycline AL 200
DinoprostoneInitial report08.01.2026OtherPrepidil Gel
Fusidic acid (Ph.Eur.)Change notification08.01.2026Production problemFucithalmic 10 mg/g eye drops
IndomethacinInitial report08.01.2026OtherIndomethacin AL 50
Oxycodone hydrochloride (Ph.Eur.)Change notification08.01.2026Production problemOxygesic injection 10 mg/ml
Lanreotide acetate (1:x) ((with information on acetic acid content))Change notification08.01.2026Production problemMytolac 120 mg solution for injection in a pre-filled syringe
Lanreotide acetate (1:x) ((with information on acetic acid content))Change notification08.01.2026Production problemMytolac 90 mg solution for injection in a pre-filled syringe
RisperidoneChange notification08.01.2026Production problemRisperidone-ratiopharm 25 mg powder and solvent for the preparation of a prolonged-release injection suspension
RisperidoneChange notification08.01.2026Production problemRisperidone-ratiopharm 37.5 mg powder and solvent for the preparation of a prolonged-release injection suspension
RisperidoneChange notification08.01.2026Production problemRisperidone-ratiopharm 50 mg powder and solvent for the preparation of a depot injection suspension
Sodium (methylprednisolone-21-succinate)Change notification07.01.2026OtherUrbason solubile forte 1000 mg
Paliperidone palmitateInitial report07.01.2026Production problemPaliperidone Advanz Pharma 150 mg depot injection suspension in a pre-filled syringe
Paliperidone palmitateInitial report07.01.2026Production problemPaliperidone Advanz Pharma 100 mg Depot injection suspension in a pre-filled syringe
Paliperidone palmitateChange notification07.01.2026Production problemPaliperidone Advanz Pharma 25 mg prolonged-release suspension for injection in a pre-filled syringe
Paliperidone palmitateChange notification07.01.2026Production problemPaliperidone Advanz Pharma 50 mg prolonged-release suspension for injection in a pre-filled syringe
Paliperidone palmitateChange notification07.01.2026Production problemPaliperidone Advanz Pharma 75 mg depot injection suspension in a pre-filled syringe
AlbendazoleInitial report07.01.2026OtherEskazole
LamotrigineInitial report07.01.2026OtherLamictal 5 mg tablets for the preparation of an oral suspension or chewable tablets
Disodium pamidronateInitial report07.01.2026Production problemPAMIDRO-cell 3 mg/ml concentrate for solution for infusion
Biperiden hydrochlorideChange notification07.01.2026Production problemBiperiden-neuraxpharm 4 mg
Biperiden hydrochlorideChange notification07.01.2026Production problemBiperiden-neuraxpharm 2 mg
Galantamine hydrobromideChange notification07.01.2026OtherGalantamine-neuraxpharm 8 mg hard capsules, delayed release
Galantamine hydrobromideChange notification07.01.2026OtherGalantamine-neuraxpharm 16 mg Hard capsules, delayed release
Galantamine hydrobromideChange notification07.01.2026OtherGalantamine-neuraxpharm 24 mg hard capsules, delayed release
Cisatracurium besylateChange notification07.01.2026OtherNimbex 5mg
Doxorubicin hydrochlorideChange notification07.01.2026Production problemDoxorubicin hydrochloride Bendalis 2 mg/ml
FluorouracilChange notification07.01.2026OtherBenda-5 FU
Somatostatin acetateChange notification07.01.2026Production problemSomatostatin 3 mg Inresa
DeferasiroxChange notification06.01.2026OtherDeferasirox Mylan 180 mg film-coated tablets
Tenofovir disoproxilChange notification06.01.2026OtherTenofovir disoproxil Viatris 245 mg film-coated tablets – OP30
Tenofovir disoproxilChange notification06.01.2026OtherTenofovir disoproxil Mylan 245 mg film-coated tablets – OP90(3×30)
Hydrochlorothiazide; ValsartanChange notification06.01.2026OtherVALSARTAN COMP BASICS 160 mg/25 mg film-coated tablets
Hydrochlorothiazide; ValsartanChange notification06.01.2026OtherVALSARTAN COMP BASICS 80 mg/12.5 mg film-coated tablets
Hydrochlorothiazide; ValsartanChange notification06.01.2026OtherVALSARTAN COMP BASICS 160 mg/12.5 mg film-coated tablets
Beclomethasone dipropionate (Ph.Eur.); formoterol fumarate dihydrate (Ph.Eur.); glycopyrronium bromide (Ph.Eur.)Initial report06.01.2026Production problemTrimbow 87 micrograms/5 micrograms/9 micrograms pressurized gas inhalation, solution – OP360 cans (3×120 cans)
AprepitantChange notification05.01.2026Production problemAprepitant beta 125 mg and 80 mg hard capsules
Atomoxetine hydrochlorideChange notification05.01.2026Production problemAtomoxetine beta 80 mg hard capsules
AprepitantChange notification05.01.2026Production problemAprepitant beta 80 mg hard capsules
Fluoxetine hydrochlorideChange notification05.01.2026OtherFluoxetine beta 20
PenicillamineChange notification05.01.2026Production problemMetalcaptase 150 mg
Iron(III) hexacyanoferrate(II)Change notification05.01.2026OtherThallium antidote
Rivastigmine hydrogen tartrateChange notification05.01.2026Production problemRivastigmine Aurobindo 6 mg hard capsules
Insulin lisproInitial report05.01.2026OtherLiprolog 200 units/ml solution for injection in pre-filled pen – OP[2x(5x3ml)]
Hydromorphone hydrochlorideChange notification05.01.2026OtherHydromorphone HCl PUREN 4 mg hard capsules, delayed release
Escitalopram oxalateChange notification05.01.2026OtherEscitalopram Aurobindo 10 mg film-coated tablets
Flucloxacillin sodium 1 H<2>OChange notification05.01.2026Production problemStaphylex 250 mg capsules
Moxifloxacin hydrochloride (Ph.Eur.) ((with information on water content (1:x)))Change notification05.01.2026OtherMoxifloxacin Holsten 400 mg film-coated tablets
Insulin lisproInitial report05.01.2026OtherLiprolog 100 E/ml KwikPen solution for injection – OP[2x(5x3ml)]
Clomipramine hydrochlorideChange notification05.01.2026Production problemAnafranil 75mg retard
Quetiapine fumarate (Ph.Eur.)Change notification05.01.2026OtherSeroquel Prolong 150 mg prolonged-release tablets
Amlodipine besylate; Perindopril tert-butylamineChange notification05.01.2026Production problemPerindopril/amlodipine Denk 8 mg/5 mg tablets
Gentamicin sulfateChange notification05.01.2026Production problemGentamicin-POS
Phenylephrine hydrochlorideChange notification05.01.2026Production problemNeosynephrine-POS 5%
Minocycline hydrochloride dihydrate (Ph.Eur.)Change notification05.01.2026Production problemSkid 50 mg
Minocycline hydrochloride dihydrate (Ph.Eur.)Change notification05.01.2026Production problemSkid 100 mg
Quetiapine fumarate (Ph.Eur.)Change notification05.01.2026OtherQuetiapine Hormosan 300 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification05.01.2026OtherQuetiapine Hormosan 400 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification05.01.2026OtherQuetiapine-Hormosan 200 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification05.01.2026OtherQuetiapine-Hormosan 150 mg prolonged-release tablets
Oxycodone hydrochloride (Ph.Eur.)Change notification05.01.2026OtherOxycan uno 10 mg prolonged-release tablets
2026年1月12日
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