BfArMボトルネック・レポート（2025年9月28日～10月5日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
Enalapril maleate; hydrochlorothiazideChange notification03.10.2025Production problemRenacor
Methyldopa (Ph.Eur.)Initial report03.10.2025Production problemPresinol 500
Cefaclor monohydrateChange notification02.10.2025OtherCefaclor 125 TS – 1 A Pharma
Cefpodoxime proxetilInitial report02.10.2025OtherCefpodoxime – 1 A Pharma 40 mg/5 ml powder for oral suspension
Morphine hemisulfate 2.5 hydrateInitial report02.10.2025Production problemSubstitol 30 mg hard capsules, delayed release
Oxycodone hydrochloride (Ph.Eur.)Change notification02.10.2025Production problemOxygesic 5 mg
RifampicinChange notification02.10.2025OtherEREMFAT 150 mg
Oxycodone hydrochlorideChange notification02.10.2025OtherOXYGESIC 10 mg
PyrazinamideInitial report02.10.2025Production problemPyrafat 500 mg
Azithromycin dihydrateChange notification02.10.2025OtherAzithromycin AL 250 mg film-coated tablets
Quetiapine fumarate (Ph.Eur.)Change notification01.10.2025Production problemQuetiapine Heumann retard 200 mg prolonged-release tablets
Calcium acetate hydrate (with information on water content (1:x))Initial report01.10.2025Production problemCalcium acetate-Nefro 950mg
Quetiapine fumarate (Ph.Eur.)Change notification01.10.2025Production problemQuetiapine Heumann retard 150 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification01.10.2025Production problemQuetiapine Heumann retard 50 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification01.10.2025Production problemQuetiapine Heumann retard 400 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification01.10.2025Production problemQuetiapine Heumann retard 300 mg prolonged-release tablets
Vinorelbine tartrateInitial report01.10.2025Production problemBendarelbin 10 mg/ml concentrate for solution for infusion
Sodium perchlorate 1 H<2>OChange notification30.09.2025OtherIrenat drops
Galantamine hydrobromideChange notification30.09.2025Production problemGalantamine Heumann 8 mg hard capsules, delayed release
Galantamine hydrobromideChange notification30.09.2025Production problemGalantamine Heumann 16 mg hard capsules, delayed release
Galantamine hydrobromideChange notification30.09.2025Production problemGalantamine Heumann 24 mg hard capsules, delayed release
Clomethiazole hemidisilateChange notification30.09.2025OtherDistraneurin mixture
Pramipexole dihydrochloride monohydrateChange notification30.09.2025OtherPramipexole HEXAL 0.26 mg prolonged-release tablets
Pramipexole dihydrochloride monohydrateChange notification30.09.2025OtherPramipexole HEXAL 0.52 mg prolonged-release tablets
Phenoxymethylpenicillin potassiumChange notification30.09.2025OtherPen Mega – 1 A Pharma
Rifampicin sodiumInitial report30.09.2025OtherEremfat i.v. 600mg
Ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid hydrate ((with information on water content (1:x))); Nicotinamide; pyridoxine hydrochloride; retinol palmitate; riboflavin phosphate sodium; thiamine hydrochloride; all-rac-phytomenadione; all-rac-alpha-tocopherolInitial report30.09.2025Production problemViant powder for solution for infusion
TropicamideChange notification30.09.2025Production problemMydriaticum Stulln UD
Ipratropium bromide (Ph.Eur.); salbutamol sulfateChange notification30.09.2025Production problemCOMBIPRASAL 0.5 mg / 2.5 mg solution for nebulizer
Ipratropium bromideChange notification30.09.2025Production problemIpratropium bromide 250 micrograms / 1 ml Stulln
Paliperidone palmitateChange notification30.09.2025OtherPaliperidone AL 25 mg depot injection suspension in a pre-filled syringe
Methylphenidate hydrochlorideChange notification30.09.2025OtherMethylphenidate AL 36 mg prolonged-release tablets
Paliperidone palmitateChange notification30.09.2025OtherPaliperidone AL 50 mg Depot injection suspension in a pre-filled syringe
Beclomethasone dipropionate (Ph.Eur.)Change notification29.09.2025OtherBeclorhinol aquosum 50 micrograms
Insulin glargineChange notification29.09.2025OtherSemglee 100 units/ml injection solution in pre-filled pen – OP(5x3ml)
Insulin glargineChange notification29.09.2025OtherSemglee
Methylphenidate hydrochlorideInitial report29.09.2025OtherEquasym Retard 40 mg hard capsules with modified release
2025年10月5日
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