BfArMボトルネック・レポート(2025年7月21日~7月27日)

Active ingredientsReport typeDate of last messageType of reasonAM designation
Duloxetine hydrochlorideChange notification25.07.2025Production problemDuloxetine PUREN 60 mg gastro-resistant hard capsules
Chorionic gonadotropinInitial report25.07.2025OtherBREVACTID 1500 I.E. Powder and solvent for solution for injection
Human insulin (with manufacturing details)Initial report25.07.2025OtherBerlinsulin H Normal 3 ml pen
Betamethasone valerate (Ph.Eur.)Initial report25.07.2025OtherSoderm crinale
AzacitidineInitial report25.07.2025OtherAzacitidine HEXAL 25 mg/ml powder for suspension for injection
Minocycline hydrochloride dihydrate (Ph.Eur.)Initial report25.07.2025Production problemSkid 100 mg
Minocycline hydrochloride dihydrate (Ph.Eur.)Initial report25.07.2025Production problemSkid 50 mg
Galantamine hydrobromideInitial report24.07.2025OtherGalanaxiro 24 mg hard capsules, delayed release
Galantamine hydrobromideInitial report24.07.2025OtherGalanaxiro 16 mg Hard capsules, delayed release
Galantamine hydrobromideInitial report24.07.2025OtherGalanaxiro 8 mg hard capsules, delayed release
LorazepamChange notification24.07.2025OtherTavor 1.0 mg Expidet
CarbamazepineChange notification24.07.2025OtherCarbamazepine AL 400 delayed release
Methylphenidate hydrochlorideChange notification24.07.2025OtherMethylphenidate AL 18 mg prolonged-release tablets
Tacrolimus monohydrateChange notification24.07.2025OtherTacrolimus AL 5 mg hard capsules, delayed release
Tacrolimus monohydrateChange notification24.07.2025OtherTacrolimus AL 1 mg hard capsules, delayed release
Tacrolimus monohydrateChange notification24.07.2025OtherTacrolimus AL 0.5 mg hard capsules, delayed release
Tacrolimus monohydrateChange notification24.07.2025OtherTacrolimus AL 3 mg hard capsules, delayed release
Duloxetine hydrochlorideChange notification24.07.2025OtherDuloxetine AL 120 mg gastro-resistant hard capsules
Quetiapine fumarate (Ph.Eur.)Change notification24.07.2025OtherQuetiapine AL 100 mg film-coated tablets
Selegiline hydrochlorideInitial report24.07.2025OtherSelegiline AL 10
Selegiline hydrochlorideChange notification24.07.2025OtherSelegiline AL 5
RibavirinChange notification24.07.2025OtherRibavirin-ratiopharm 400 mg film-coated tablets
Insulin aspartInitial report23.07.2025OtherNovoRapid 100 E/ml solution for injection in vial – OP[5x(1x10ml)]
Paliperidone palmitateChange notification23.07.2025OtherPaliperidone AL 25 mg depot injection suspension in a pre-filled syringe
Azithromycin dihydrateInitial report23.07.2025OtherAzithromycin AL 250 mg film-coated tablets
Insulin lisproInitial report22.07.2025OtherLiprolog 100 E/ml solution for injection in vial – OP[5x(1x10ml)]
Trandolapril; verapamil hydrochlorideChange notification22.07.2025Production problemTarka 240 mg/2 mg tablets with modified release
Zoledronic acid monohydrateChange notification22.07.2025OtherZole – 1 A Pharma 5 mg/100 ml infusion solution
Trimipramine mesylateChange notification22.07.2025OtherTrimipramine – 1 A Pharma 40 mg/ml oral drops, solution
Pramipexole dihydrochloride monohydrateChange notification22.07.2025OtherPramipexole HEXAL 0.52 mg prolonged-release tablets
Cyclophosphamide monohydrateChange notification22.07.2025OtherCyclophosphamide HEXAL 2000 mg
ChlortalidoneChange notification22.07.2025OtherChlortalidone HEXAL 50 mg tablets
SemaglutideChange notification22.07.2025OtherOzempic 1 mg injection solution in a pre-filled pen – OP(3x3ml)
ChlortalidoneChange notification22.07.2025OtherChlortalidone HEXAL 25 mg tablets
Atomoxetine hydrochlorideChange notification22.07.2025OtherAtomoxe – 1 A Pharma 80 mg hard capsules
Atomoxetine hydrochlorideChange notification22.07.2025OtherAtomoxe – 1 A Pharma 60 mg hard capsules
Atomoxetine hydrochlorideChange notification22.07.2025OtherAtomoxe – 1 A Pharma 40 mg hard capsules
Atomoxetine hydrochlorideChange notification22.07.2025OtherAtomoxe – 1 A Pharma 25 mg hard capsules
Atomoxetine hydrochlorideChange notification22.07.2025OtherAtomoxe – 1 A Pharma 18 mg hard capsules
Atomoxetine hydrochlorideChange notification22.07.2025OtherAtomoxe – 1 A Pharma 100 mg hard capsules
Atomoxetine hydrochlorideChange notification22.07.2025OtherAtomoxe – 1 A Pharma 10 mg hard capsules
UrapidilInitial report21.07.2025OtherEbrantil 30 mg
LidocaineInitial report21.07.2025Production problemXYLOCAIN PUMP SPRAY
Salbutamol sulfateChange notification21.07.2025OtherBronchospray novo
Quetiapine fumarate (Ph.Eur.)Change notification21.07.2025Production problemQuetiapine Heumann retard 150 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification21.07.2025Production problemQuetiapine Heumann retard 400 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification21.07.2025Production problemQuetiapine Heumann retard 50 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification21.07.2025Production problemQuetiapine Heumann retard 200 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification21.07.2025Production problemQuetiapine Heumann retard 300 mg prolonged-release tablets
Flunisolid hemihydrateChange notification21.07.2025OtherSyntaris
Framycetin sulfate (Ph.Eur.)Change notification21.07.2025OtherLeukase N ointment
FluorouracilChange notification21.07.2025OtherFluorouracil Hikma 50 mg/ml solution for injection
2025年7月28日
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