BfArMボトルネック・レポート（2025年7月7日～7月13日）

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Active ingredients
Report type
Date of last messageType of reasonAM designation
Methyl (5-amino-4-oxopentanoate) hydrochlorideInitial report11.07.2025OtherMetvix 160 mg/g cream
SemaglutideInitial report11.07.2025OtherOzempic 1 mg injection solution in a pre-filled pen – OP(3x3ml)
Salbutamol sulfateChange notification11.07.2025OtherSultanol inhalation solution
Salbutamol sulfateChange notification11.07.2025OtherSultanol metered aerosol
Flunisolid hemihydrateChange notification11.07.2025OtherSyntaris
Framycetin sulfate (Ph.Eur.)Change notification11.07.2025OtherLeukase N ointment
Human insulin (with manufacturing details); Isophane insulin suspension for injection (Ph.Eur.)Initial report11.07.2025OtherActraphane 30 FlexPen 100 IU/ml injection suspension in injector – OP(10x3ml)
Insulin aspartInitial report11.07.2025OtherNovoMix 30 FlexPen 100 IU/ml injection suspension in pre-filled syringe – OP(10x3ml)
Promethazine hydrochlorideInitial report11.07.2025Production problemAtosil injection solution N
Paliperidone palmitateInitial report11.07.2025OtherXEPLION 50 mg depot injection suspension – OP1ml
Paliperidone palmitateInitial report11.07.2025OtherXEPLION 25 mg depot injection suspension – OP1ml
Ampicillin sodiumInitial report10.07.2025Production problemAmpicillin Eberth 1 g powder for solution for injection/infusion
TrometamolInitial report10.07.2025OtherTham-Köhler
TrometamolInitial report10.07.2025OtherTHAM-Köhler 3 M
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification10.07.2025OtherAtorvastatin Aristo 60 mg film-coated tablets
Cinacalcet hydrochlorideInitial report10.07.2025OtherCinacalcet Mylan 60 mg film-coated tablets – OP(28×1)
Pramipexole dihydrochloride monohydrateChange notification10.07.2025OtherPramipexole Mylan 0.52 mg prolonged-release tablets
Pramipexole dihydrochloride monohydrateChange notification10.07.2025OtherPramipexole Mylan 0.26 mg prolonged-release tablets
Trandolapril; verapamil hydrochlorideChange notification10.07.2025Production problemTarka 240 mg/2 mg modified-release tablets
Sufentanil citrateInitial report10.07.2025Production problemSufenta 50 micrograms/ml solution for injection
DeferasiroxChange notification10.07.2025OtherDeferasirox Mylan 180 mg film-coated tablets
Potassium canrenoateChange notification10.07.2025Production problemAldactone 10 ml Canrenoate
OxazepamChange notification10.07.2025OtherOxazepam AL 10
Amoxicillin trihydrateChange notification10.07.2025OtherAmoxicillin AL TS
Isophane insulin suspension for injection (Ph.Eur.)Change notification09.07.2025OtherProtaphane FlexPen 100 IU/ml injection suspension in injector – OP (10x3ml)
EstriolInitial report09.07.2025OtherOvestin 1 mg cream
PropofolInitial report09.07.2025OtherDISOPRIVAN 1%
Lidocaine hydrochloride monohydrateInitial report09.07.2025OtherXylocaine Gel 2%
AzathioprineInitial report09.07.2025OtherImurek 25 mg film-coated tablets
Levothyroxine sodium (Ph.Eur.)Initial report09.07.2025OtherThevier 100
Levothyroxine sodium (Ph.Eur.)Initial report09.07.2025OtherThevier 50
Methylphenidate hydrochlorideInitial report09.07.2025OtherMethylphenidate-ratiopharm 20 mg modified-release hard capsules
Methylphenidate hydrochlorideInitial report09.07.2025OtherMethylphenidate-ratiopharm 40 mg hard capsules with modified release
Methyldopa (Ph.Eur.)Initial report08.07.2025Production problemPresinol 125
Methyldopa (Ph.Eur.)Initial report08.07.2025Production problemPresinol 500
Velmanase alfaInitial report08.07.2025OtherLamzede 10 mg powder for solution for infusion – OP(10×250,815mg)
Doxepine hydrochloride (Ph.Eur.)Change notification08.07.2025Production problemDoxepin 25 Holsten
DesfluraneInitial report08.07.2025Production problemSuprane
CarbamazepineInitial report08.07.2025OtherCarbamazepine AL 400 retard
CarbamazepineInitial report08.07.2025OtherCarbamazepine AL 200 retard
Quetiapine fumarate (Ph.Eur.)Change notification08.07.2025OtherQuetiapine-ratiopharm 300 mg prolonged-release tablets
OxazepamChange notification08.07.2025OtherOxa-CT 10 mg tablets
Quetiapine fumarate (Ph.Eur.)Change notification08.07.2025OtherQuetiapine AbZ 150 mg prolonged-release tablets
Calcium acetate hydrate ((with information on water content (1:x)))Initial report07.07.2025Production problemRenacet 950 mg
Midodrine hydrochlorideInitial report07.07.2025OtherGutron tablets
DL-lysine acetylsalicylate – glycine (9:1)Initial report07.07.2025Production problemAcetylsalicylic acid Panpharma i.v. 500 mg
Salbutamol sulfateInitial report07.07.2025OtherBronchospray Autohaler
2025年7月14日
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