BfArMボトルネック・レポート(2025年8月11日~8月17日)

Active ingredients
Report type
Date of last messageType of reasonAM designation
Sertraline hydrochlorideChange notification15.08.2025OtherSertraline TAD 100 mg film-coated tablets
Sertraline hydrochlorideChange notification15.08.2025OtherSertraline TAD 50 mg film-coated tablets
Phenoxybenzamine hydrochlorideChange notification15.08.2025OtherDibenzyran 10
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification15.08.2025OtherAtorvastatin Micro Labs 20 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification15.08.2025OtherAtorvastatin Micro Labs 40 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification15.08.2025OtherAtorvastatin Micro Labs 80 mg film-coated tablets
RifampicinChange notification15.08.2025Production problemEREMFAT 450 mg
Acetylcholine chlorideChange notification15.08.2025Production problemMiochol-E powder and solvent for the preparation of an instillation solution for intraocular use
Azithromycin dihydrateChange notification15.08.2025OtherAzithromycin AL 250 mg film-coated tablets
Galantamine hydrobromideChange notification14.08.2025Production problemGalantamine Heumann 24 mg hard capsules, delayed release
Quetiapine fumarate (Ph.Eur.)Change notification14.08.2025Production problemQuetiapine Heumann retard 200 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification14.08.2025Production problemQuetiapine Heumann retard 150 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification14.08.2025Production problemQuetiapine Heumann retard 50 mg prolonged-release tablets
Sodium diphosphate decahydrate for the manufacture of radioactive medicinal productsInitial14.08.2025OtherTechnescan PYP
TobramycinChange notification14.08.2025Production problemTOBI Podhaler 28 mg hard capsules with powder for inhalation – OP224(4×56)
AlprazolamInitial14.08.2025OtherAlprazolam-ratiopharm 1.0 mg tablets
Emtricitabine; tenofovir disoproxil maleateChange notification14.08.2025OtherEmtricitabine/tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets – OP30(Fl)
Naloxegol oxalateInitial13.08.2025OtherMoventig 25 mg film-coated tablets – OP100(100×1)
IsoniazidChange notification13.08.2025OtherIsozid 200 mg
Methyl (5-amino-4-oxopentanoate) hydrochlorideChange notification12.08.2025OtherMetvix 160 mg/g cream
OlanzapineInitial12.08.2025Production problemOlanzapine Glenmark 5 mg tablets – OP70
OlanzapineInitial12.08.2025Production problemOlanzapine Glenmark 2.5 mg tablets – OP70
OlanzapineInitial12.08.2025Production problemOlanzapine Glenmark 2.5 mg tablets – OP56
OlanzapineInitial12.08.2025Production problemOlanzapine Glenmark 10 mg tablets – OP70
OlanzapineInitial12.08.2025Production problemOlanzapine Glenmark 10 mg tablets – OP56
Trazodone hydrochlorideChange notification12.08.2025Production problemTrazodone Glenmark 100 mg tablets
Rizatriptan benzoateChange notification12.08.2025Production problemRizatriptan Glenmark 10 mg tablets
Rizatriptan benzoateChange notification12.08.2025Production problemRizatriptan Glenmark 10 mg orodispersible tablets
Rizatriptan benzoateChange notification12.08.2025Production problemRizatriptan Glenmark 5 mg orodispersible tablets
Rizatriptan benzoateChange notification12.08.2025Production problemRizatriptan Glenmark 5 mg tablets
Quetiapine fumarate (Ph.Eur.)Initial12.08.2025Production problemQuetiapine Glenmark 300 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification12.08.2025Production problemQuetiapine Glenmark 400 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification12.08.2025Production problemQuetiapine Glenmark 200 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification12.08.2025Production problemQuetiapine Glenmark 150 mg prolonged-release tablets
Mometasone furoate (Ph.Eur.)Change notification12.08.2025Production problemMometasone Glenmark 1 mg/g ointment
LinezolidChange notification12.08.2025Production problemLinezolid Glenmark 600 mg film-coated tablets
Galantamine hydrobromideChange notification12.08.2025Production problemGalantamine Glenmark 24 mg hard capsules, delayed release
Galantamine hydrobromideChange notification12.08.2025Production problemGalantamine Glenmark 8 mg hard capsules, delayed release
Galantamine hydrobromideChange notification12.08.2025Production problemGalantamine Glenmark 16 mg hard capsules, delayed release
PirfenidoneInitial12.08.2025Production problemPirfenidone Accord 801 mg film-coated tablets
Ezetimibe; SimvastatinInitial12.08.2025Production problemEzetimibe/Simvastatin Glenmark 10 mg/20 mg tablets
AlprazolamInitial12.08.2025OtherAlprazolam – 1 A Pharma 1 mg tablets
AlprazolamInitial12.08.2025OtherAlprazolam – 1 A Pharma 0.5 mg tablets
GabapentinInitial12.08.2025Production problemGabapentin Holsten 800 mg film-coated tablets
GabapentinInitial12.08.2025OtherGabapentin Holsten 100 mg hard capsules
Doxepine hydrochloride (Ph.Eur.)Initial12.08.2025OtherDoxepin 75 Holsten
Zoledronic acid monohydrateChange notification12.08.2025Production problemZoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion – OP5ml
RifampicinInitial12.08.2025OtherEREMFAT 300 mg
Vancomycin hydrochlorideInitial12.08.2025OtherVancomycin “Lederle” 1000 mg
UrapidilChange notification12.08.2025OtherUrapidil PUREN 90 mg prolonged-release capsules
TopiramateChange notification12.08.2025Production problemTopiramate PUREN 100 mg film-coated tablets
Sitagliptin hydrochloride monohydrateChange notification12.08.2025Production problemSitagliptin PUREN 50 mg film-coated tablets
Sitagliptin hydrochloride monohydrateChange notification12.08.2025Production problemSitagliptin Aurobindo 25 mg film-coated tablets
Rizatriptan benzoateChange notification12.08.2025Production problemRizatriptan PUREN 5 mg tablets
Rizatriptan benzoateChange notification12.08.2025OtherRizatriptan PUREN 10 mg tablets
Rizatriptan benzoateChange notification12.08.2025OtherRizatriptan Aurobindo 10 mg orodispersible tablets
RisperidoneChange notification12.08.2025OtherRisperidone PUREN 1 mg film-coated tablets
RisperidoneChange notification12.08.2025OtherRisperidone Aurobindo 1 mg film-coated tablets
DocetaxelChange notification12.08.2025OtherDocetaxel Aurobindo 20 mg/ml concentrate for solution for infusion
NevirapineChange notification12.08.2025OtherNevirapine Aurobindo 400 mg prolonged-release tablets
Moxifloxacin hydrochloride (Ph.Eur.) (with information on water content (1:x))Change notification12.08.2025Production problemMoxifloxacin Aurobindo 400 mg film-coated tablets
Moxifloxacin hydrochloride (Ph.Eur.) (with information on water content (1:x))Change notification12.08.2025Production problemMoxifloxacin PUREN 400 mg film-coated tablets
IbuprofenChange notification12.08.2025OtherIBU-PUREN acute 400 mg film-coated tablets
Oxycodone hydrochloride (Ph.Eur.)Change notification11.08.2025OtherOxygesic 5 mg
Paliperidone palmitateChange notification11.08.2025Production problemPaliperidone Advanz Pharma 25 mg Depot injection suspension in a pre-filled syringe
Paliperidone palmitateChange notification11.08.2025Production problemPaliperidone Advanz Pharma 50 mg depot injection suspension in a pre-filled syringe
Hydromorphone hydrochlorideChange notification11.08.2025OtherHydromorphone HEXAL 2.6 mg hard capsules
Insulin aspartInitial11.08.2025OtherNovoRapid PumpCart 100 E/ml injection solution in cartridge – OP[5x(5×1.6ml)]
ChlortalidoneChange notification11.08.2025OtherChlortalidone HEXAL 25 mg tablets
ChlortalidoneChange notification11.08.2025OtherChlortalidone HEXAL 50 mg tablets
SufentanilInitial11.08.2025Production problemSufentanil-hameln 50 micrograms/ml injection/infusion solution
Oxycodone hydrochloride (Ph.Eur.)Initial11.08.2025OtherOxycodone-HCl HEXAL 40 mg prolonged-release tablets
Oxycodone hydrochloride (Ph.Eur.)Initial11.08.2025OtherOxycodone-HCl HEXAL 20 mg prolonged-release tablets
Oxycodone hydrochloride (Ph.Eur.)Initial11.08.2025OtherOxycodone-HCl HEXAL 10 mg prolonged-release tablets
Oxycodone hydrochloride (Ph.Eur.)Initial11.08.2025OtherOxycodone-HCl HEXAL 5 mg prolonged-release tablets
Hydromorphone hydrochlorideChange notification11.08.2025OtherHydromorphone HCl PUREN 4 mg hard capsules, delayed release
Escitalopram oxalateChange notification11.08.2025OtherEscitalopram Aurobindo 10 mg film-coated tablets
EtoricoxibChange notification11.08.2025OtherEtoricoxib PUREN 120 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification11.08.2025OtherAtorvastatin PUREN 40 mg film-coated tablets
GabapentinChange notification11.08.2025OtherGabapentin Aurobindo 400 mg hard capsules
PrasugrelChange notification11.08.2025Production problemPrasugrel PUREN 5 mg film-coated tablets
LamotrigineChange notification11.08.2025Production problemLamotrigine Aurobindo 50 mg tablets
RamiprilChange notification11.08.2025OtherRamipril PUREN 5 mg tablets
PregabalinChange notification11.08.2025OtherPregabalin Aurobindo 25 mg hard capsules
PregabalinChange notification11.08.2025OtherPregabalin PUREN 100 mg hard capsules
2025年8月18日
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