BfArMボトルネック・レポート(2025年11月24日~11月30日)

Active ingredients
Message type
Date of last messageType of reasonAM designation
Moxifloxacin hydrochloride (Ph.Eur.) ((with information on water content (1:x)))Change notification28.11.2025OtherMoxifloxacin Micro Labs 400 mg film-coated tablets
Levothyroxine sodiumChange notification28.11.2025Production problemL-thyroxine Henning 50
Levothyroxine sodiumChange notification28.11.2025Production problemL-Thyroxine Aventis 150 microgram tablets
IvermectinInitial report28.11.2025OtherDRIPONIN 3 mg tablets
Escitalopram oxalateInitial report28.11.2025Production problemEscitalopram STADA 20 mg film-coated tablets
Rifampicin sodiumChange notification28.11.2025OtherEremfat i.v. 600mg
Insulin glargineChange notification28.11.2025OtherSemglee
Insulin glargineChange notification28.11.2025OtherSemglee 100 units/ml solution for injection in pre-filled pen – OP(5x3ml)
PosaconazoleInitial report28.11.2025Production problemNoxafil
OlanzapineInitial report27.11.2025Production problemZyprexa 2.5 mg coated tablets – OP70 (blister pack)
IbuprofenInitial report27.11.2025Production problemIbuprofen Kabi 400 mg solution for infusion
AdenosineChange notification27.11.2025Production problemAdenosine Altamedics 3 mg/ml solution for injection
AdenosineChange notification27.11.2025Production problemAdenosine Altamedics 30 mg/10 ml solution for infusion
Tacrolimus monohydrateChange notification27.11.2025OtherTacrolimus AL 3 mg hard capsules, delayed release
Tacrolimus monohydrateChange notification27.11.2025OtherTacrolimus AL 0.5 mg hard capsules, delayed release
Tacrolimus monohydrateChange notification27.11.2025OtherTacrolimus AL 1 mg hard capsules, delayed release
Tacrolimus monohydrateChange notification27.11.2025OtherTacrolimus AL 5 mg hard capsules, delayed release
Quetiapine fumarate (Ph.Eur.)Initial report27.11.2025OtherSeroquel 25 mg film-coated tablets
Quetiapine fumarate (Ph.Eur.)Change notification27.11.2025OtherSeroquel Prolong 200 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification27.11.2025OtherSeroquel Prolong 300 mg prolonged-release tablets
Tolterodine tartrateChange notification27.11.2025OtherDetrusitol 2 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification27.11.2025OtherAtorvastatin Aristo 80 mg film-coated tablets
PrimidoneChange notification27.11.2025Production problemMylepsinum
Doxepin hydrochloride (Ph.Eur.)Change notification26.11.2025Production problemDoxepin 25 Holsten
Doxepin hydrochloride (Ph.Eur.)Change notification26.11.2025Production problemDoxepin 75 Holsten
Amlodipine besylate; hydrochlorothiazide; valsartanChange notification26.11.2025OtherAmlodipine/Valsartan/HCT Holsten 5 mg/160 mg/12.5 mg film-coated tablets
GabapentinChange notification26.11.2025Production problemGabapentin Holsten 800 mg film-coated tablets
PrednicarbatInitial report26.11.2025Production problemPrednicarbat acis solution
Haloperidol decanoateChange notification26.11.2025Production problemHaloperidol-neuraxpharm decanoate 100 mg/ml
Haloperidol decanoateChange notification26.11.2025Production problemHaloperidol-neuraxpharm decanoate 50 mg/ml
Dexketoprofen trometamolChange notification26.11.2025Production problemSympal inject 50 mg solution for injection/infusion
Pramipexole dihydrochloride monohydrateChange notification26.11.2025OtherPramipexole Mylan 3.15 mg prolonged-release tablets
Isosorbide mononitrateChange notification26.11.2025Production problemISMN STADA 40 mg tablets
Isosorbide mononitrateChange notification26.11.2025Production problemISMN STADA 20 mg tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification25.11.2025OtherAtorvastatin PUREN 40 mg film-coated tablets
Rivastigmine hydrogen tartrateChange notification25.11.2025Production problemRivastigmine Aurobindo 6 mg hard capsules
PrasugrelChange notification25.11.2025Production problemPrasugrel PUREN 5 mg film-coated tablets
NevirapineChange notification25.11.2025OtherNevirapine Aurobindo 400 mg prolonged-release tablets
Flucloxacillin sodium 1 H<2>OChange notification25.11.2025Production problemStaphylex 250 mg capsules
Moxifloxacin hydrochloride (Ph.Eur.) ((with information on water content (1:x)))Change notification25.11.2025OtherMoxifloxacin Holsten 400 mg film-coated tablets
OxazepamChange notification25.11.2025OtherOxazepam AL 10
Methylphenidate hydrochlorideChange notification25.11.2025OtherMetiphenal 10 mg modified-release hard capsules
Mannitol (Ph.Eur.)Initial report25.11.2025OtherBronchitol 40 mg hard capsule with powder for inhalation – OP10(1×10)
AlprazolamInitial report25.11.2025OtherAlprazolam – 1 A Pharma 0.5 mg tablets
GabapentinChange notification25.11.2025OtherGabapentin Holsten 100 mg hard capsules
Oxycodone hydrochlorideChange notification24.11.2025OtherOXYGESIC 10 mg
Olipudase alfaInitial report24.11.2025Production problemXenpozyme
Benzylpenicillin benzathine tetrahydrate (Ph.Eur.) ((with information on the dispersing or suspending agent))Initial report24.11.2025Production problemTardocillin 1200
BenperidolInitial report24.11.2025Production problemGlianimon 2 ml
Mivacurium chlorideInitial report24.11.2025Production problemMivacron 20mg
PregabalinChange notification24.11.2025OtherPregabalin PUREN 100 mg hard capsules
Quetiapine fumarate (Ph.Eur.)Change notification24.11.2025Production problemQuetiapine – 1 A Pharma 150 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification24.11.2025Production problemQuetiapine HEXAL 150 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification24.11.2025Production problemQuetiapine HEXAL 50 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification24.11.2025Production problemQuetiapine HEXAL 400 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification24.11.2025Production problemQuetiapine – 1 A Pharma 300 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification24.11.2025Production problemQuetiapine – 1 A Pharma 400 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification24.11.2025Production problemQuetiapine – 1 A Pharma 50 mg prolonged-release tablets
Salbutamol sulfateChange notification24.11.2025OtherBronchospray novo
Quetiapine fumarate (Ph.Eur.)Change notification24.11.2025Production problemQuetiapine – 1 A Pharma 600 mg prolonged-release tablets
Cefaclor monohydrateChange notification24.11.2025OtherCefaclor 125 TS – 1 A Pharma
ProgesteroneChange notification24.11.2025Production problemLUTINUS 100 mg vaginal tablets
Tinzaparin sodiumInitial report24.11.2025Production probleminnohep 4,500 Anti-Xa I.E. Solution for injection
Vancomycin hydrochlorideChange notification24.11.2025OtherVancomycin “Lederle” 1000mg
2025年12月1日
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