BfArMボトルネック・レポート（1月12日～1月18日）

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Active ingredientsMessage typeDate of last messageType of reasonAM designation
Metformin hydrochlorideChange notification16.01.2026OtherMetformin 500 – 1 A Pharma
Pramipexole dihydrochloride monohydrateChange notification16.01.2026OtherPramipexole – 1 A Pharma 0.26 mg prolonged-release tablets
AlprazolamChange notification16.01.2026OtherAlprazolam – 1 A Pharma 0.5 mg tablets
TetrabenazineChange notification16.01.2026OtherTetrabenazine Aristo 25 mg tablets
Tamoxifen citrateChange notification16.01.2026Production problemTamoxifen Aristo 10 mg tablets
NitrendipineChange notification16.01.2026Production problemNitrendipine Aristo 20 mg film-coated tablets
Von Willebrand factorChange notification16.01.2026OtherWILLFACT 1000 I.U.
Calcium acetate; heavy, basic magnesium carbonateChange notification16.01.2026Production problemOsvaRen
Methyldopa (Ph.Eur.)Initial report16.01.2026OtherDopegyt tablets
Rifampicin sodiumChange notification16.01.2026OtherEremfat i.v. 600mg
LorazepamChange notification15.01.2026OtherTavor 2.5 mg Expidet
Insulin aspartInitial report15.01.2026Production problemFiasp 100 units/ml solution for injection in pre-filled pen – OP10[2x(5x3ml)]
Clonidine hydrochlorideChange notification15.01.2026OtherClonidine-ratiopharm 75
Clonidine hydrochlorideChange notification15.01.2026OtherClonidine-ratiopharm 150
Clonidine hydrochlorideChange notification15.01.2026OtherClonidine-ratiopharm 300
Sufentanil citrateChange notification15.01.2026Production problemSufenta mite
Naloxone hydrochloride dihydrate; oxycodone hydrochloride (Ph.Eur.)Initial report15.01.2026Production problemTargin 40 mg/20 mg prolonged-release tablets
PrimidoneChange notification15.01.2026Production problemMylepsinum
BuprenorphineChange notification15.01.2026OtherBuprenorphine AWD Matrix 70 micrograms/h Transdermal patch
BuprenorphineChange notification15.01.2026OtherBuprenorphine AWD Matrix 52.5 micrograms/h Transdermal patch
Colistimethate sodiumChange notification15.01.2026Production problemColistin CF
Ipratropium bromide (Ph.Eur.)Change notification15.01.2026Production problemIpratropium Teva 250 micrograms/1 ml solution for nebulizer
NitrendipineChange notification15.01.2026OtherNitrendipine AbZ 20 mg tablets
NitrendipineChange notification15.01.2026OtherNitrendipine-ratiopharm 10 mg tablets
BuprenorphineChange notification15.01.2026OtherBuprenorphine-ratiopharm 35 micrograms/h transdermal patch
BuprenorphineChange notification15.01.2026OtherBuprenorphine-ratiopharm 52.5 micrograms/h transdermal patch
BuprenorphineChange notification15.01.2026OtherBuprenorphine-ratiopharm 70 micrograms/h transdermal patch
EverolimusChange notification15.01.2026OtherEverolimus-ratiopharm 10 mg tablets
EverolimusChange notification15.01.2026OtherEverolimus-ratiopharm 2.5 mg tablets
EverolimusChange notification15.01.2026OtherEverolimus-ratiopharm 5 mg tablets
Fibrinogen, humanChange notification15.01.2026OtherFibryga
AlprazolamChange notification15.01.2026OtherAlprazolam-ratiopharm 1.0 mg tablets
NitrendipineChange notification15.01.2026OtherNitrendipine-ratiopharm 20 mg tablets
Methylphenidate hydrochlorideChange notification14.01.2026OtherMETHYLPHENIDATE 20 mg tablets
Sumatriptan succinateInitial report14.01.2026Production problemMIGRAPEN 3 mg/0.5 ml solution for injection in a pre-filled pen
Ipratropium bromide (Ph.Eur.); salbutamol sulfateChange notification14.01.2026Production problemCOMBIPRASAL 0.5 mg / 2.5 mg solution for nebulizer
TropicamideChange notification14.01.2026Production problemMydriaticum Stulln UD
Ethambutol dihydrochlorideInitial report14.01.2026Production problemEMB-FATOL 400 mg
DinoprostoneChange notification14.01.2026Production problemMinprostin E2 vaginal tablets
DinoprostoneChange notification14.01.2026OtherMinprostin E2 vaginal gel 1mg
DinoprostoneChange notification14.01.2026OtherMinprostin E2 vaginal gel 2 mg
Tacrolimus monohydrateChange notification14.01.2026OtherTacrolimus AL 5 mg hard capsules, delayed release
Tacrolimus monohydrateChange notification14.01.2026OtherTacrolimus AL 1 mg hard capsules, delayed release
Tacrolimus monohydrateChange notification14.01.2026OtherTacrolimus AL 0.5 mg hard capsules, delayed release
Tacrolimus monohydrateChange notification14.01.2026OtherTacrolimus AL 3 mg hard capsules, delayed release
RifampicinInitial report14.01.2026Production problemEremfat syrup
RifampicinInitial report14.01.2026Production problemEREMFAT 450 mg
AlprazolamChange notification14.01.2026OtherAlprazolam AbZ 0.5 mg tablets
Methylphenidate hydrochlorideChange notification14.01.2026OtherMethylphenidate hydrochloride-neuraxpharm 27 mg prolonged-release tablets
(2-aminoethyl)dihydrogen phosphate calcium salt (1:1)Change notification14.01.2026OtherCalcium EAP
Sodium (methylprednisolone-21-succinate)Change notification13.01.2026OtherUrbason solubile forte 250 mg
Sodium (methylprednisolone-21-succinate)Change notification13.01.2026OtherUrbason soluble forte 1000 mg
Rizatriptan benzoateChange notification13.01.2026OtherRizatriptan PUREN 10 mg tablets
LevetiracetamInitial report13.01.2026Production problemLevetiracetam Holsten 750 mg film-coated tablets
LevetiracetamInitial report13.01.2026Production problemLevetiracetam Holsten 500 mg film-coated tablets
LevetiracetamChange notification13.01.2026Production problemLevetiracetam Holsten 250 mg film-coated tablets
Fluphenazine decanoateChange notification13.01.2026Production problemFluphenazine-neuraxpharm D 100 mg/ml
Fluphenazine decanoateChange notification13.01.2026Production problemFluphenazine-neuraxpharm D 25 mg/ml
Fluphenazine decanoateChange notification13.01.2026Production problemFluphenazine-neuraxpharm D 12.5 mg/0.5 ml
Fluphenazine decanoateChange notification13.01.2026Production problemFluphenazine-neuraxpharm D 50 mg/0.5 ml
Clonidine hydrochlorideInitial report13.01.2026Production problemClonistada 0.3 mg tablets
ErythromycinInitial report13.01.2026OtherInderm
AprepitantChange notification13.01.2026OtherAprepitant AL 125 mg and 80 mg hard capsules
AprepitantChange notification13.01.2026OtherAprepitant AL 125 mg hard capsules
AprepitantChange notification13.01.2026OtherAprepitant AL 80 mg hard capsules
Quetiapine fumarate (Ph.Eur.)Change notification13.01.2026OtherQuetiapine AL 50 mg prolonged-release tablets
Propranolol hydrochlorideInitial report13.01.2026OtherDOCITON 80mg
Fluoxetine hydrochlorideChange notification13.01.2026OtherFluoxetine Micro Labs 60 mg hard capsules
Fluoxetine hydrochlorideChange notification13.01.2026OtherFluoxetine Micro Labs 30 mg hard capsules
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification13.01.2026OtherAtorvastatin Micro Labs 30 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification13.01.2026OtherAtorvastatin Micro Labs 60 mg film-coated tablets
Citalopram hydrobromideChange notification13.01.2026Production problemCitalopram STADA 10 mg film-coated tablets
Ciprofloxacin sulfate (1:1)Initial report12.01.2026Production problemCiprofloxacin Kabi 200 mg/100 ml solution for infusion
Galantamine hydrobromideChange notification12.01.2026OtherGalanaxiro 8 mg hard capsules, delayed release
Galantamine hydrobromideChange notification12.01.2026OtherGalanaxiro 16 mg hard capsules, delayed release
Galantamine hydrobromideChange notification12.01.2026OtherGalanaxiro 24 mg hard capsules, delayed release
2026年1月19日
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