BfArMボトルネック・レポート（2025年10月13日～10月19日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
Lidocaine hydrochloride monohydrateChange notification17.10.2025OtherXylocaine Gel 2%
EstriolInitial report17.10.2025OtherOvestin 1 mg cream
Mivacurium chlorideInitial report17.10.2025OtherMivacron 10 mg
LidocaineInitial report17.10.2025OtherXYLOCAIN PUMP SPRAY dental
Salbutamol sulfateChange notification17.10.2025OtherSultanol forte ready-to-use inhalation solution
Levothyroxine sodiumInitial report17.10.2025Production problemL-thyroxine Henning 50
Levothyroxine sodiumInitial report17.10.2025Production problemL-thyroxine Henning 125
Levothyroxine sodiumInitial report17.10.2025Production problemL-Thyroxine Henning 75
Gentamicin sulfateInitial report17.10.2025Production problemGentamicin-POS
Phenylephrine hydrochlorideChange notification17.10.2025Production problemNeosynephrine-POS 5%
FampridineChange notification17.10.2025OtherFAMPRIDIN BASICS 10 mg prolonged-release tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Initial report17.10.2025OtherATORVASTATIN BASICS 80 mg film-coated tablets
Olanzapine embonate monohydrateInitial report17.10.2025OtherZYPADHERA 405 mg powder and solvent for the preparation of a prolonged-release injection suspension – OP(931mg+3ml)
Candesartan cilexetilInitial report17.10.2025OtherATACAND 16 mg
Olanzapine embonate monohydrateChange notification17.10.2025Production problemZYPADHERA 210 mg powder and solvent for the preparation of a prolonged-release suspension for injection – OP(483mg+3ml)
Methyldopa (Ph.Eur.)Initial report17.10.2025Production problemPresinol 250
Insulin detemirInitial report17.10.2025OtherLevemir 100 IU solution for injection in pre-filled pen – OP(10x3ml)(FlexPen)
Insulin detemirInitial report17.10.2025OtherLevemir 100 IU injection solution in cartridge – OP(10x3ml)
Betamethasone dipropionate (Ph.Eur.); gentamicin sulfateInitial report16.10.2025OtherDiprogenta
PosaconazoleInitial report16.10.2025OtherPosaconazole HEXAL 40 mg/ml oral suspension
OxytocinInitial report16.10.2025Production problemOxytocin 3 IU Hexal
Human insulin (with manufacturing details)Initial report16.10.2025OtherBerlinsulin H Basal 3 ml pen
Insulin aspartChange notification16.10.2025OtherNovoMix 30 FlexPen 100 IU/ml injection suspension in pre-filled syringe – OP(10x3ml)
Human insulin (with manufacturing details)Initial report15.10.2025OtherBerlinsulin H Normal 3 ml pen
MethylprednisoloneInitial report15.10.2025OtherMethylprednisolone 4mg JENAPHARM
Azithromycin dihydrateChange notification15.10.2025OtherAzithromycin AL 250 mg film-coated tablets
Vancomycin hydrochlorideChange notification15.10.2025Production problemVancomycin Lyomark 500 mg
Vancomycin hydrochlorideChange notification15.10.2025Production problemVancomycin Lyomark 1000 mg powder for concentrate for solution for infusion or oral solution
PosaconazoleInitial report15.10.2025OtherPosaconazole AL 40 mg/ml oral suspension
Methylphenidate hydrochlorideInitial report15.10.2025OtherMetiphenal 10 mg modified-release hard capsules
Folic acid hydrate (with information on water content (1:x))Initial report15.10.2025OtherFolic acid AL 5 mg tablets
AcitretinInitial report15.10.2025OtherAcicutan 25 mg hard capsules
Fusidic acid (Ph.Eur.)Initial report15.10.2025OtherFusicutan ointment
OxazepamInitial report15.10.2025OtherDurazepam 50 mg forte
Oxycodone hydrochloride (Ph.Eur.)Initial report14.10.2025Production problemOxygesic Dispersa acute 5 mg
Oxycodone hydrochloride (Ph.Eur.)Initial report14.10.2025Production problemOxygesic Dispersa acute 10 mg
Oxycodone hydrochlorideChange notification14.10.2025OtherOXYGESIC 10 mg
Arsenic(III) oxideInitial report14.10.2025OtherTRISENOX 2 mg/ml concentrate for solution for infusion
Granisetron hydrochlorideInitial report14.10.2025OtherKevatril 3 mg/3 ml solution for injection
CarboplatinInitial report14.10.2025OtherCarboplatin Kabi 10 mg/ml concentrate for solution for infusion
Dexketoprofen trometamolInitial report14.10.2025Production problemSympal inject 50 mg injection/infusion solution
Tolterodine tartrateInitial report14.10.2025OtherDetrusitol 2 mg film-coated tablets
Doxepin hydrochloride (Ph.Eur.)Initial report14.10.2025OtherDoxepin-ratiopharm 50 mg film-coated tablets
Doxepin hydrochloride (Ph.Eur.)Initial report14.10.2025OtherDoxepin-ratiopharm 25 mg film-coated tablets
ThiamazoleInitial report13.10.2025OtherThiamazole 5 mg Henning
Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y)Change notification13.10.2025OtherFerrlecit 62.5 mg
Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y)Change notification13.10.2025OtherFerrlecit 40 mg
Cisatracurium besylateChange notification13.10.2025OtherNimbex 10 mg
ZolbetuximabChange notification13.10.2025OtherVyloy
Paliperidone palmitateInitial report13.10.2025OtherXEPLION 50 mg prolonged-release suspension for injection – OP1ml
2025年10月20日
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