BfArMボトルネック・レポート（2025年12月15日～12月21日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
AprepitantChange notification19.12.2025OtherEMEND 125 mg powder for oral suspension – OPXXXXmg
ErythromycinInitial report19.12.2025Production problemAknemycin solution
Fibrinogen, humanChange notification19.12.2025Production problemHaemocomplettan P 1g
Fibrinogen, humanChange notification19.12.2025Production problemHaemocomplettan P 2g
Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y)Change notification19.12.2025OtherFerrlecit 62.5 mg
Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y)Change notification19.12.2025OtherFerrlecit 40 mg
PosaconazoleChange notification19.12.2025Production problemNoxafil
Esomeprazole hemimagnesiumChange notification19.12.2025Production problemESOMEPRAZOLE BASICS 40 mg gastro-resistant hard capsules
Candesartan cilexetilChange notification19.12.2025OtherCANDESARTAN BASICS 32 mg tablets
Candesartan cilexetilChange notification19.12.2025OtherCANDESARTAN BASICS 16 mg tablets
Candesartan cilexetilChange notification19.12.2025OtherCANDESARTAN BASICS 8 mg tablets
Candesartan cilexetilChange notification19.12.2025OtherCANDESARTAN BASICS 4 mg tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification19.12.2025OtherATORVASTATIN BASICS 80 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification19.12.2025OtherATORVASTATIN BASICS 30 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification19.12.2025OtherATORVASTATIN BASICS 20 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification19.12.2025OtherATORVASTATIN BASICS 10 mg film-coated tablets
Ciprofloxacin hydrochloride monohydrateChange notification19.12.2025OtherCIPRO BASICS 750 mg film-coated tablets
Ciprofloxacin hydrochloride monohydrateChange notification19.12.2025OtherCIPRO BASICS 250 mg film-coated tablets
Ezetimibe; simvastatinChange notification19.12.2025Production problemEZETIMIB/SIMVA BASICS 10 mg/80 mg tablets
Ezetimibe; simvastatinChange notification19.12.2025Production problemEZETIMIB/SIMVA BASICS 10 mg/40 mg tablets
Ezetimibe; simvastatinChange notification19.12.2025Production problemEZETIMIB/SIMVA BASICS 10 mg/20 mg tablets
Ezetimibe; simvastatinChange notification19.12.2025Production problemEZETIMIBE/SIMVA BASICS 10 mg/10 mg tablets
Esomeprazole hemimagnesiumChange notification19.12.2025Production problemESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsules
Betamethasone acetate (Ph.Eur.); Betamethasone dihydrogen phosphate disodium (Ph.Eur.)Initial report19.12.2025OtherCelestan Depot
MesalazineChange notification19.12.2025OtherClaversal 500 mg tablets
Terazosin hydrochloride dihydrateChange notification19.12.2025OtherHeitrin 2 mg
Proxymetacaine hydrochlorideChange notification19.12.2025Production problemProparacaine-POS 0.5%
Gentamicin sulfateChange notification19.12.2025Production problemGentamicin POS
Phenylephrine hydrochlorideChange notification19.12.2025Production problemNeosynephrine-POS 10%
Epoetin thetaInitial report18.12.2025Production problemEporatio 4000 IU/0.5 ml injection solution in pre-filled syringe – OP (6×0.5 ml)
EtanerceptInitial report18.12.2025OtherNepexto 50 mg solution for injection in a pre-filled syringe
EtanerceptInitial report18.12.2025OtherNepexto 50 mg solution for injection in a pre-filled syringe
EtanerceptInitial report18.12.2025OtherNepexto 50 mg solution for injection in a pre-filled pen
EtanerceptInitial report18.12.2025OtherNepexto 50 mg solution for injection in a pre-filled pen
Rifampicin sodiumChange notification18.12.2025OtherEremfat i.v. 600mg
UrapidilChange notification18.12.2025Production problemUrapidil Bluefish 90 mg hard capsules, delayed release
UrapidilChange notification18.12.2025Production problemUrapidil Bluefish 30 mg hard capsules, delayed release
Hydromorphone hydrochlorideChange notification18.12.2025OtherHydromorphone PAINBREAK 8 mg prolonged-release tablets
Hydromorphone hydrochlorideChange notification18.12.2025OtherHydromorphone PAINBREAK 4 mg prolonged-release tablets
Hydromorphone hydrochlorideChange notification18.12.2025OtherHydromorphone PAINBREAK 24 mg prolonged-release tablets
Hydromorphone hydrochlorideChange notification18.12.2025OtherHydromorphone PAINBREAK 16 mg prolonged-release tablets
Dexamethasone dihydrogen phosphate disodium (Ph.Eur.)Initial report18.12.2025OtherDexafluid 1 mg/ml eye drops
Ipratropium bromide (Ph.Eur.)Change notification18.12.2025Production problemIpratropium Teva 250 micrograms/1 ml solution for nebulizer
Quetiapine fumarate (Ph.Eur.)Change notification18.12.2025OtherQuetiapine AbZ 150 mg prolonged-release tablets
NitrendipineChange notification18.12.2025OtherNitrendipine AbZ 10 mg tablets
Quetiapine fumarate (Ph.Eur.)Change notification18.12.2025OtherQuetiapine-ratiopharm 300 mg prolonged-release tablets
Pramipexole dihydrochloride monohydrateChange notification18.12.2025OtherPramipexole-ratiopharm 0.52 mg prolonged-release tablets
Propranolol hydrochlorideChange notification18.12.2025OtherPropra-ratiopharm 10 mg film-coated tablets
Propranolol hydrochlorideChange notification18.12.2025OtherPropra-ratiopharm 40 mg film-coated tablets
Propranolol hydrochlorideChange notification18.12.2025OtherPropra-ratiopharm 80 mg film-coated tablets
NitrendipineChange notification18.12.2025OtherNitrendipine-ratiopharm 20 mg tablets
Galantamine hydrobromideChange notification18.12.2025OtherGalantamine-ratiopharm 24 mg hard capsules, delayed release
Galantamine hydrobromideChange notification18.12.2025OtherGalantamine-ratiopharm 16 mg hard capsules, delayed release
Galantamine hydrobromideChange notification18.12.2025OtherGalantamine-ratiopharm 8 mg hard capsules, delayed release
Doxepine hydrochloride (Ph.Eur.)Change notification18.12.2025OtherDoxepin-ratiopharm 50 mg film-coated tablets
Doxepine hydrochloride (Ph.Eur.)Change notification18.12.2025OtherDoxepin-ratiopharm 25 mg film-coated tablets
Dexamethasone dihydrogen phosphate disodium (Ph.Eur.)Change notification18.12.2025OtherDexa-ratiopharm 4 mg solution for injection
Clonidine hydrochlorideChange notification18.12.2025OtherClonidine-ratiopharm 300
Clonidine hydrochlorideChange notification18.12.2025OtherClonidine-ratiopharm 150
Clonidine hydrochlorideChange notification18.12.2025OtherClonidine-ratiopharm 75
Cinacalcet hydrochlorideChange notification18.12.2025OtherCinacalcet-ratiopharm 30 mg film-coated tablets
AlprazolamChange notification18.12.2025OtherAlprazolam-ratiopharm 1.0 mg tablets
AlprazolamChange notification18.12.2025OtherAlprazolam-ratiopharm 0.5 mg tablets
NitrendipineChange notification18.12.2025OtherNitrendipine AL 10
AnastrozoleChange notification18.12.2025OtherAnastrozole Denk 1 mg film-coated tablets
Folic acid hydrate (with information on water content (1:x))Change notification18.12.2025OtherFolic acid AL 5 mg tablets
Erythromycin lactobionateChange notification17.12.2025Production problemErythrocin-i.v. 1.0 g
Methyldopa (Ph.Eur.)Change notification17.12.2025Production problemMethyldopa STADA 250 mg film-coated tablet
Insulin aspartChange notification17.12.2025OtherNovoRapid PumpCart 100 E/ml solution for injection in cartridge – OP[5x(5×1.6ml)]
Paliperidone palmitateChange notification17.12.2025OtherPaliperidone AL 50 mg Depot injection suspension in a pre-filled syringe
AprepitantChange notification17.12.2025OtherAprepitant AL 80 mg hard capsules
AprepitantChange notification17.12.2025OtherAprepitant AL 125 mg hard capsules
AprepitantChange notification17.12.2025OtherAprepitant AL 125 mg and 80 mg hard capsules
Zoledronic acid monohydrateChange notification17.12.2025OtherZoledronic acid AL 4 mg/100 ml solution for infusion
Potassium canrenoateInitial report17.12.2025Production problemAldactone 10 ml Canrenoate
Salbutamol sulfateInitial report16.12.2025OtherBronchospray novo
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification16.12.2025OtherAtorvastatin Micro Labs 10 mg film-coated tablets
LevetiracetamChange notification16.12.2025Production problemLevetiracetam Holsten 250 mg film-coated tablets
Moxifloxacin hydrochloride (Ph.Eur.) ((with information on water content (1:x)))Change notification16.12.2025OtherMoxifloxacin Holsten 400 mg film-coated tablets
Quetiapine fumarate (Ph.Eur.)Change notification16.12.2025OtherQuetiapine AL 50 mg prolonged-release tablets
PropofolInitial report16.12.2025Production problemPropofol-Lipuro 10 mg/ml
Isosorbide mononitrateChange notification16.12.2025OtherISMN AL40 retard
Isosorbide mononitrateChange notification16.12.2025OtherISMN AL 100 retard
PrimidoneInitial report16.12.2025OtherPrimidone Holsten
Amikacin sulfateChange notification16.12.2025Production problemAmikacin B. Braun 5 mg/ml infusion solution
Amoxicillin trihydrateChange notification16.12.2025OtherAmoxicillin AL TS
Cefixime 3 H<2>OChange notification16.12.2025OtherCefixime AL 100 mg/5 ml powder for oral suspension
Dexketoprofen trometamolChange notification16.12.2025Production problemSympal inject 50 mg solution for injection/infusion
Selegiline hydrochlorideChange notification16.12.2025OtherSelegiline AL 5
Clonidine hydrochlorideChange notification15.12.2025Production problemClonistada 0.15 mg tablets
Lidocaine hydrochloride monohydrateChange notification15.12.2025OtherXylocaine Gel 2%
LidocaineChange notification15.12.2025OtherXYLOCAIN PUMP SPRAY dental
Calcium chloride dihydrate; histidine; histidine hydrochloride monohydrate; potassium hydrogen 2-oxopentanedioate; potassium chloride; magnesium chloride hexahydrate; mannitol (Ph.Eur.); sodium chloride; tryptophanChange notification15.12.2025Production problemCustodiol
Rosuvastatin calcium (Ph.Eur.)Change notification15.12.2025OtherRosuvastatin Aurobindo 20 mg film-coated tablets
Buprenorphine hydrochlorideChange notification15.12.2025OtherBuprenorphine PUREN 8 mg sublingual tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification15.12.2025OtherAtorvastatin PUREN 40 mg film-coated tablets
AlprazolamChange notification15.12.2025OtherAlprazolam – 1 A Pharma 0.5 mg tablets
OxytocinChange notification15.12.2025Production problemOxytocin 3 I.E. Hexal
Galantamine hydrobromideChange notification15.12.2025OtherGalantamine – 1A Pharma 24 mg prolonged-release hard capsules
Galantamine hydrobromideChange notification15.12.2025OtherGalantamine – 1A Pharma 8 mg prolonged-release hard capsules
Galantamine hydrobromideChange notification15.12.2025OtherGalantamine – 1A Pharma 16 mg prolonged-release hard capsules
OxcarbazepineChange notification15.12.2025OtherOxcarbazepine – 1 A Pharma 60 mg/ml oral suspension
Quetiapine fumarate (Ph.Eur.)Change notification15.12.2025Production problemQuetiapine HEXAL 300 mg prolonged-release tablets
Indapamide; Perindopril arginineInitial report15.12.2025OtherPerindopril arginine/indapamide Viatris 5 mg/1.25 mg film-coated tablets
2025年12月22日
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