BfArMボトルネック・レポート(2025年9月22日~9月27日)

Active ingredients
Message type
Date of last messageType of reasonAM designation
Tinzaparin sodiumInitial report26.09.2025Production probleminnohep 4,500 Anti-Xa I.E. Solution for injection
Paliperidone palmitateChange notification26.09.2025OtherXEPLION 25 mg prolonged-release suspension for injection – OP1ml
Quetiapine fumarate (Ph.Eur.)Change notification26.09.2025OtherSeroquel Prolong 400 mg prolonged-release tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification25.09.2025OtherAtorvastatin Micro Labs 80 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification25.09.2025OtherAtorvastatin Micro Labs 40 mg film-coated tablets
AprepitantInitial report25.09.2025OtherAprepitant AL 125 mg and 80 mg hard capsules
Isosorbide mononitrateChange notification25.09.2025OtherISMN AL40 retard
Isosorbide mononitrateChange notification25.09.2025OtherISMN AL 100 retard
Quetiapine fumarate (Ph.Eur.)Change notification25.09.2025OtherQuetiapine AL 200 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification25.09.2025OtherQuetiapine AL 300 mg film-coated tablets
Quetiapine fumarate (Ph.Eur.)Change notification25.09.2025OtherQuetiapine AL 300 mg prolonged-release tablets
Phenylephrine hydrochlorideChange notification25.09.2025Production problemNeosynephrine-POS 5%
AprepitantChange notification25.09.2025OtherAprepitant AL 80 mg hard capsules
AprepitantChange notification25.09.2025OtherAprepitant AL 125 mg hard capsules
Epirubicin hydrochlorideChange notification25.09.2025Production problemEpirubicin Hikma 2 mg/ml concentrate for solution for infusion
Rivastigmine hydrogen tartrateChange notification25.09.2025Production problemRivastigmine Aurobindo 6 mg hard capsules
LiraglutideChange notification25.09.2025OtherSaxenda 6 mg/ml solution for injection in pre-filled pen – OP(5x3ml)
LiraglutideChange notification25.09.2025OtherSaxenda 6 mg/ml solution for injection in pre-filled pen – OP(3x3ml)
Insulin aspartInitial report24.09.2025Production problemFiasp
SemaglutideInitial report24.09.2025Production problemOzempic 0.5 mg solution for injection in a pre-filled pen – OP1.5 ml
ProgesteroneInitial report24.09.2025Production problemLUTINUS 100 mg vaginal tablets
Sodium perchlorate 1 H<2>OChange notification24.09.2025OtherIrenat drops
Rifampicin sodiumChange notification24.09.2025Production problemEremfat i.v. 300mg
Methylphenidate hydrochlorideChange notification24.09.2025OtherMethylphenidate AL 27 mg prolonged-release tablets
Azithromycin dihydrateChange notification24.09.2025OtherAzithromycin AL 250 mg film-coated tablets
Quetiapine fumarate (Ph.Eur.)Change notification24.09.2025OtherSeroquel Prolong 150 mg prolonged-release tablets
Clomipramine hydrochlorideChange notification23.09.2025Production problemAnafranil 75mg prolonged-release
VibegronInitial report23.09.2025Production problemObgemsa
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification23.09.2025OtherAtorvastatin Micro Labs 60 mg film-coated tablets
SevelamerChange notification23.09.2025OtherRenagel 800 mg film-coated tablets – OP(1×180)
Trimipramine mesylateChange notification23.09.2025OtherTrimipramine – 1 A Pharma 40 mg/ml oral drops, solution
OxcarbazepineChange notification23.09.2025OtherOxcarbazepine – 1 A Pharma 60 mg/ml oral suspension
Atomoxetine hydrochlorideChange notification23.09.2025OtherAtomoxe – 1 A Pharma 80 mg hard capsules
Atomoxetine hydrochlorideChange notification23.09.2025OtherAtomoxe – 1 A Pharma 60 mg hard capsules
Atomoxetine hydrochlorideChange notification23.09.2025OtherAtomoxe – 1 A Pharma 40 mg hard capsules
Atomoxetine hydrochlorideChange notification23.09.2025OtherAtomoxe – 1 A Pharma 25 mg hard capsules
Atomoxetine hydrochlorideChange notification23.09.2025OtherAtomoxe – 1 A Pharma 18 mg hard capsules
Atomoxetine hydrochlorideChange notification23.09.2025OtherAtomoxe – 1 A Pharma 100 mg hard capsules
Atomoxetine hydrochlorideChange notification23.09.2025OtherAtomoxe – 1 A Pharma 10 mg hard capsules
Fosfomycin sodium (Ph.Eur.)Change notification23.09.2025Production problemFosfomycin Eberth 4 g powder for solution for infusion
Fosfomycin sodium (Ph.Eur.)Change notification23.09.2025Production problemFosfomycin Eberth 2 g powder for solution for infusion
HydrocortisoneInitial report22.09.2025Production problemAlkindi 5 mg granules for removal from capsule – OP50
DomperidoneChange notification22.09.2025Production problemMotilium drops 10 mg/ml suspension
Naloxone hydrochloride dihydrate; oxycodone hydrochloride (Ph.Eur.)Change notification22.09.2025Production problemOxycodone/naloxone Krugmann 20 mg/10 mg prolonged-release tablets
Naloxone hydrochloride dihydrate; oxycodone hydrochloride (Ph.Eur.)Change notification22.09.2025Production problemOxycodone / Naloxone Krugmann 40 mg/20 mg prolonged-release tablets
Oxycodone hydrochlorideChange notification22.09.2025OtherOXYGESIC 10 mg
Hydromorphone hydrochlorideChange notification22.09.2025Production problemPalladon inject 20 mg/ml solution for injection/infusion
Calcium chloride dihydrate; histidine; histidine hydrochloride monohydrate; potassium hydrogen 2-oxopentanedioate; potassium chloride; magnesium chloride hexahydrate; mannitol (Ph.Eur.); sodium chloride; tryptophanChange notification22.09.2025Production problemCustodiol
Beclomethasone dipropionate (Ph.Eur.)Change notification22.09.2025OtherBeclorhinol aquosum 50 micrograms
ImiquimodInitial report22.09.2025Production problemImikeraderm 50 mg/g cream
Trandolapril; verapamil hydrochlorideInitial report22.09.2025OtherTarka 240 mg/4 mg modified-release tablets
2025年9月28日
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