BfArMボトルネック・レポート(2025年9月1日~9月7日)

Active ingredientsMessage typeDate of last messageType of reasonAM designation
Amantadine hemisulfateChange notification05.09.2025OtherPK-Merz Infusion
Sodium (methylprednisolone-21-succinate)Change notification05.09.2025OtherUrbason soluble forte 1000 mg
Ipratropium bromide (Ph.Eur.); salbutamol sulfateChange notification05.09.2025Production problemCOMBIPRASAL 0.5 mg / 2.5 mg solution for nebulizer
Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y)Change notification05.09.2025OtherFerrlecit 40 mg
Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y)Change notification05.09.2025OtherFerrlecit 62.5 mg
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification05.09.2025OtherAtorvastatin Micro Labs 10 mg film-coated tablets
Esomeprazole hemimagnesiumChange notification04.09.2025Production problemESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsules
CarbamazepineInitial report04.09.2025Production problemTegretal 400 mg retard
Olanzapine embonate monohydrateChange notification04.09.2025Production problemZYPADHERA 300 mg powder and solvent for the preparation of a depot injection suspension – OP(690mg+3ml)
OlanzapineChange notification04.09.2025Production problemZyprexa 7.5 mg coated tablets – OP70(blister)
OlanzapineInitial report04.09.2025Production problemZYPREXA
Olanzapine embonate monohydrateChange notification04.09.2025Production problemZYPADHERA 405 mg powder and solvent for the preparation of a depot injection suspension – OP(931mg+3ml)
Human insulin (with manufacturing information)Initial report04.09.2025OtherHuminsulin Basal (NPH) for Pen 3 ml 100 IU/ml injection suspension in cartridge
Betamethasone dipropionate (Ph.Eur.); gentamicin sulfateInitial report04.09.2025OtherDiprogenta cream
Methylphenidate hydrochlorideInitial report04.09.2025OtherMethylphenidate AL 36 mg prolonged-release tablets
Paliperidone palmitateChange notification04.09.2025OtherPaliperidone AL 50 mg depot injection suspension in a pre-filled syringe
Insulin lisproInitial report03.09.2025OtherLiprolog Mix50 100 /ml KwikPen injection suspension – OP[2x(5x3ml)]
Human insulin (with manufacturing information)Initial report03.09.2025OtherHuminsulin Basal (NPH) KwikPen 100 IU/ml injection suspension
FluorouracilChange notification03.09.2025OtherFluorouracil PhaRes 50 mg/ml solution for injection
Phenytoin sodiumChange notification03.09.2025Production problemPhenhydan Injection solution
Methyl (5-amino-4-oxopentanoate) hydrochlorideChange notification03.09.2025OtherMetvix 160 mg/g cream
Monosodium alendronateChange notification03.09.2025OtherALENDRONIC ACID BASICS once weekly 70 mg tablets
Pramipexole dihydrochloride monohydrateChange notification03.09.2025OtherPramipexole-ratiopharm 0.26 mg prolonged-release tablets
Dexamethasone; gentamicin sulfateInitial report03.09.2025Production problemDexa-Gentamicin
Gentamicin sulfateChange notification03.09.2025Production problemGentamicin POS
Ezetimibe; simvastatinInitial report02.09.2025Production problemEZETIMIB/SIMVA BASICS 10 mg/80 mg tablets
Ezetimibe; simvastatinInitial report02.09.2025Production problemEZETIMIBE/SIMVA BASICS 10 mg/40 mg tablets
Ezetimibe; simvastatinInitial report02.09.2025Production problemEZETIMIBE/SIMVA BASICS 10 mg/20 mg tablets
Ezetimibe; simvastatinInitial report02.09.2025Production problemEZETIMIBE/SIMVA BASICS 10 mg/10 mg tablets
Chorionic gonadotropinInitial report02.09.2025OtherBREVACTID 5000 IU powder and solvent for solution for injection
Oxycodone hydrochloride (Ph.Eur.)Change notification02.09.2025OtherOxycodone hydrochloride – 1 A Pharma 10 mg prolonged-release tablets
Methylphenidate hydrochlorideChange notification02.09.2025OtherMethylphenidate AL 27 mg prolonged-release tablets
Methylphenidate hydrochlorideChange notification02.09.2025OtherMethylphenidate AL 18 mg prolonged-release tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification02.09.2025OtherAtorvastatin PUREN 40 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification02.09.2025OtherAtorvastatin PUREN 10 mg film-coated tablets
UrapidilChange notification02.09.2025OtherUrapidil PUREN 90 mg prolonged-release capsules
NevirapineChange notification02.09.2025OtherNevirapine Aurobindo 400 mg prolonged-release tablets
RisperidoneChange notification02.09.2025OtherRisperidone Aurobindo 1 mg film-coated tablets
RisperidoneChange notification02.09.2025OtherRisperidone PUREN 1 mg film-coated tablets
PregabalinChange notification02.09.2025OtherPregabalin Aurobindo 25 mg hard capsules
Rivastigmine hydrogen tartrateChange notification02.09.2025Production problemRivastigmine Aurobindo 6 mg hard capsules
Timolol maleateInitial report01.09.2025Production problemTim-Ophtal 0.5% sine
Trandolapril; verapamil hydrochlorideChange notification01.09.2025OtherTarka 180 mg/2 mg modified-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification01.09.2025OtherSeroquel Prolong 50 mg prolonged-release tablets
2025年9月8日
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