BfArMボトルネック・レポート(2025年6月23日~6月29日)

Active ingredients
Notification type
Date of last notificationType of reasonAM designation
Oxycodone hydrochloride (Ph.Eur.)Change notification27.06.2025OtherOxygesic 5 mg
Hydromorphone hydrochlorideChange notification27.06.2025OtherPalladon 2.6 mg hard capsules
Quetiapine fumarate (Ph.Eur.)Change notification27.06.2025OtherSeroquel Prolong 50 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification27.06.2025OtherSeroquel Prolong 200 mg prolonged-release tablets
LiraglutideFirst notification27.06.2025OtherSaxenda 6 mg/ml solution for injection in prefilled pen – OP(5x3ml)
Insulin human ((with manufacturing information))First notification27.06.2025OtherActrapid Penfill 100 I.U./ml solution for injection in cylinder ampoule – OP(10x3ml)
LiraglutideChange notification27.06.2025OtherSaxenda 6 mg/ml solution for injection in prefilled pen – OP(3x3ml)
Procaine hydrochlorideChange notification26.06.2025OtherProcaine 2% JENAPHARM
Procaine hydrochlorideChange notification26.06.2025OtherProcaine 1 % JENAPHARM
Human fibrinogenChange notification26.06.2025OtherFibCLOT
CiclosporinChange notification26.06.2025OtherCiclosporin dura 25 mg soft capsules
Dacarbazine citrateChange notification26.06.2025Production problemDacarbazine Lipomed 500 mg powder for solution for infusion
Galantamine hydrobromideChange notification25.06.2025Production problemGalantamine Heumann 24 mg hard capsules, retarded
LorazepamChange notification25.06.2025OtherTavor 2.5 mg Expidet
Diclofenac sodiumFirst notification25.06.2025OtherVoltaren 50 mg suppository
EverolimusFirst notification25.06.2025Production problemVotubia 5 mg tablets for oral suspension – OP30
Oxycodone hydrochloride (Ph.Eur.)First notification25.06.2025Production problemOxycodone hydrochloride – 1 A Pharma 5 mg prolonged-release tablets
Galantamine hydrobromideChange notification25.06.2025Production problemGalantamine Heumann 16 mg hard capsules, retarded
Galantamine hydrobromideChange notification25.06.2025Production problemGalantamine Heumann 8 mg hard capsules, retarded
Oxycodone hydrochloride (Ph.Eur.)First notification25.06.2025OtherOxycodone hydrochloride – 1 A Pharma 10 mg prolonged-release tablets
AprepitantChange notification25.06.2025Production problemAprepitant STADA 125 mg and 80 mg hard capsules
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification25.06.2025Production problemAtorvastatin STADA 80 mg film-coated tablets
Sodium mycophenolateChange notification25.06.2025OtherMycophenolic acid HEXAL 360 mg enteric-coated tablets
CiclosporinChange notification25.06.2025OtherCiclosporin Hexal 100 mg
Salbutamol sulfateChange notification25.06.2025OtherSalbutamol AL inhalation
Methylphenidate hydrochlorideChange notification25.06.2025OtherMethylene dihydrochloride HEXAL 36 mg prolonged-release tablets
Tacrolimus monohydrateChange notification25.06.2025OtherTacrolimus AL 0.5 mg Hard capsules, prolonged-release
Tacrolimus monohydrateChange notification25.06.2025OtherTacrolimus AL 1 mg hard capsules, delayed-release
Tacrolimus monohydrateChange notification25.06.2025OtherTacrolimus AL 3 mg hard capsules, prolonged-release
Tacrolimus monohydrateChange notification25.06.2025OtherTacrolimus AL 5 mg hard capsules, prolonged-release
Quetiapine fumarate (Ph.Eur.)Change notification25.06.2025OtherQuetiapine AL 150 mg prolonged-release tablets
Cefixime 3 H<2>OChange notification25.06.2025OtherCefixim AL 100 mg/5 ml Powder for oral suspension
Sugammadex sodiumFirst notification25.06.2025Production problemSugammadex Amomed
Ipratropium bromide (Ph.Eur.)Change notification25.06.2025Production problemIpratropium Teva 250 micrograms / 1 ml solution for a nebulizer
Epinephrine/adrenalineChange notification25.06.2025Production problemAnapen 500 micrograms solution for injection
RisperidoneChange notification25.06.2025Production problemRisperidon-ratiopharm 50 mg powder and solvent for the preparation of a depot injection suspension
RisperidoneChange notification25.06.2025Production problemRisperidone-ratiopharm 37.5 mg powder and solvent for the preparation of a suspension for depot injection
RisperidoneChange notification25.06.2025Production problemRisperidone-ratiopharm 25 mg powder and solvent for the preparation of a depot suspension for injection
Azithromycin dihydrateChange notification25.06.2025OtherAzithromycin-ratiopharm 500 mg film-coated tablets
Pramipexole dihydrochloride monohydrateChange notification25.06.2025OtherPramipexole-ratiopharm 0.26 mg prolonged-release tablets
Galantamine hydrobromideChange notification25.06.2025OtherGalantamine-ratiopharm 16 mg hard capsules, retarded
Galantamine hydrobromideChange notification25.06.2025OtherGalantamine-ratiopharm 24 mg hard capsules, delayed-release
Galantamine hydrobromideChange notification25.06.2025OtherGalantamine-ratiopharm 8 mg hard capsules, delayed-release
Methylphenidate hydrochlorideChange notification25.06.2025OtherMethylphenidate AL 18 mg prolonged-release tablets
ChlortalidoneChange notification24.06.2025OtherChlortalidone HEXAL 50 mg tablets
ChlortalidoneFirst notification24.06.2025OtherChlortalidone HEXAL 25 mg tablets
ChlortalidoneFirst notification24.06.2025OtherChlortalidone HEXAL 12.5 mg tablets
Phenylephrine hydrochlorideChange notification24.06.2025Production problemNeosynephrine-POS 10%
Fluoxetine hydrochlorideFirst notification24.06.2025Production problemFluoxetine-neuraxpharm 40 mg
Fluoxetine hydrochlorideFirst notification24.06.2025Production problemFluoxetine-neuraxpharm 20 mg T
Fluoxetine hydrochlorideFirst notification24.06.2025Production problemFluoxetine-neuraxpharm 20 mg
Fluoxetine hydrochlorideFirst notification24.06.2025Production problemFluoxetine-neuraxpharm 10 mg
Paliperidone palmitateFirst notification24.06.2025OtherNiapelf
Flecainide acetateFirst notification24.06.2025OtherTambocor
Paliperidone palmitateFirst notification24.06.2025OtherNiapelf
Darifenacin hydrobromideFirst notification24.06.2025OtherEmselex 7.5 mg prolonged-release tablets – OP49
Mometasone furoate (Ph.Eur.)First notification24.06.2025OtherMomecutan solution
Terbutaline sulphate (Ph.Eur.)First notification23.06.2025Production problemBRICANYL 0.5 mg
AdenosineChange notification23.06.2025Production problemAdenosine Altamedics 30 mg/10 ml solution for infusion
PraziquantelFirst notification23.06.2025OtherBiltricide
Azithromycin dihydrateChange notification23.06.2025OtherAzithromycin HEXAL 200 mg/5 ml Powder for oral suspension
AcemetacinFirst notification23.06.2025OtherRantudil forte
2025年6月30日
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