BfArMボトルネック・レポート（2025年11月10日～11月16日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
Hydromorphone hydrochlorideInitial report14.11.2025Production problemPalladon inject 2 mg
Sevelamer carbonateInitial report14.11.2025OtherRenvela 0.8 g powder for oral suspension – OP(90×842.32mg)
PirfenidoneChange notification14.11.2025Production problemPirfenidone Accord 801 mg film-coated tablets
DinoprostoneInitial report14.11.2025OtherMinprostin E2 vaginal gel 2 mg
DinoprostoneInitial report14.11.2025OtherMinprostin E2 vaginal gel 1 mg
Sertraline hydrochlorideChange notification14.11.2025OtherSertraline TAD 100 mg film-coated tablets
Sertraline hydrochlorideChange notification14.11.2025OtherSertraline TAD 50 mg film-coated tablets
Methyldopa (Ph.Eur.)Change notification14.11.2025OtherDopegyt tablets
Quetiapine fumarate (Ph.Eur.)Change notification14.11.2025OtherSeroquel Prolong 150 mg prolonged-release tablets
Trandolapril; verapamil hydrochlorideChange notification13.11.2025OtherTarka 240 mg/4 mg modified-release tablets
PosaconazoleChange notification13.11.2025OtherPosaconazole AL 40 mg/ml oral suspension
Methylphenidate hydrochlorideChange notification13.11.2025OtherMetiphenal 10 mg modified-release hard capsules
Quetiapine fumarate (Ph.Eur.)Change notification13.11.2025OtherQuetiapine AL 150 mg prolonged-release tablets
Proxymetacaine hydrochlorideInitial report12.11.2025Production problemProparacaine-POS 0.5%
Quetiapine fumarate (Ph.Eur.)Change notification12.11.2025OtherSeroquel Prolong 50 mg prolonged-release tablets
Tamsulosin hydrochlorideInitial report12.11.2025OtherTamsulosin hydrochloride PUREN 0.4 mg prolonged-release capsules
PregabalinChange notification12.11.2025OtherPregabalin Aurobindo 25 mg hard capsules
IbuprofenInitial report12.11.2025Production problemIbuprofen PUREN 600 mg film-coated tablets
GabapentinInitial report12.11.2025OtherGabapentin Aurobindo 600 mg film-coated tablets
UrapidilInitial report12.11.2025OtherUrapidil PUREN 60 mg prolonged-release capsules
UrapidilInitial report12.11.2025OtherUrapidil PUREN 30 mg prolonged-release capsules
FentanylChange notification12.11.2025Production problemFentanyl PUREN 25 micrograms/h transdermal patch
LamotrigineInitial report12.11.2025Production problemLamotrigine Aurobindo 5 mg tablets for oral suspension
Rizatriptan benzoateChange notification12.11.2025Production problemRizatriptan PUREN 5 mg tablets
Sitagliptin hydrochloride monohydrateInitial report12.11.2025OtherSitagliptin PUREN 25 mg film-coated tablets
Gemcitabine hydrochlorideInitial report12.11.2025OtherGemcitabine Aurobindo 40 mg/ml concentrate for solution for infusion
MesalazineChange notification12.11.2025Production problemClaversal Micropellets 1.5 g
RisperidoneInitial report12.11.2025OtherRisperidone PUREN 3 mg film-coated tablets
RisperidoneInitial report12.11.2025OtherRisperidone PUREN 0.5 mg film-coated tablets
MesalazineInitial report12.11.2025OtherClaversal 500 mg tablets
Propranolol hydrochlorideInitial report12.11.2025OtherPropranolol PUREN 10 mg film-coated tablets
Buprenorphine hydrochlorideInitial report12.11.2025OtherBuprenorphine PUREN 8 mg sublingual tablets
Oxycodone hydrochloride (Ph.Eur.)Initial report12.11.2025OtherOxycodone hydrochloride Puren 10 mg prolonged-release tablets
LevetiracetamInitial report12.11.2025OtherLevetiracetam PUREN 1000 mg film-coated tablets
LevetiracetamInitial report12.11.2025OtherLevetiracetam Aurobindo 1000 mg film-coated tablets
LamotrigineInitial report12.11.2025OtherLamotrigine Aurobindo 25 mg tablets
Efavirenz; emtricitabine; tenofovir disoproxil fumarateInitial report12.11.2025OtherEfavirenz/emtricitabine/tenofovir disoproxil PUREN 600 mg/200 mg/245 mg film-coated tablets
LinezolidInitial report12.11.2025OtherLinezolid PUREN 600 mg film-coated tablets
RisperidoneInitial report12.11.2025OtherRisperidone Aurobindo 1 mg film-coated tablets
Olanzapine embonate monohydrateInitial report11.11.2025Production problemZYPADHERA 405 mg powder and solvent for the preparation of a depot injection suspension – OP(931mg+3ml)
AprepitantChange notification11.11.2025OtherAprepitant AL 125 mg hard capsules
OxazepamChange notification11.11.2025OtherOxazepam AL 10
Ciprofloxacin hydrochloride (1:1) 1 H<2>OChange notification11.11.2025OtherCiprohexal 100 mg
Ciprofloxacin hydrochloride (1:1) 1 H<2>OChange notification11.11.2025OtherCipro-1 A Pharma 100mg
Terbutaline sulfate (Ph.Eur.)Change notification11.11.2025Production problemBRICANYL 0.5 mg
NimodipineChange notification10.11.2025OtherNimodipine Hexal 30mg
Insulin lisproInitial report10.11.2025OtherLiprolog 100 E/ml solution for injection in cartridge – OP[2x(5x3ml)]
Human insulin (with manufacturing details)Initial report10.11.2025OtherHuminsulin Normal KwikPen 100 IU/ml solution for injection
Calcium trisodium pentetate (with information on water content, if applicable)Initial report10.11.2025OtherTechnescan DTPA
SevelamerChange notification10.11.2025OtherRenagel 800 mg film-coated tablets – OP(1×180)
Tenofovir disoproxil fumarateInitial report10.11.2025OtherTenofovir disoproxil PUREN 245 mg film-coated tablets
LidocaineInitial report10.11.2025OtherXYLOCAIN PUMP SPRAY
Vinflunine bis[(R,R)-tartrate]Initial report10.11.2025Production problemJavlor 25 mg/ml concentrate for solution for infusion – OP (1x2ml)
Ipratropium bromide (Ph.Eur.); salbutamol sulfateChange notification10.11.2025Production problemIpratropium/salbutamol Cipla 0.5 mg/2.5 mg solution for nebulizer
ValsartanInitial report10.11.2025Production problemValsartan STADA 80 mg film-coated tablets
ValsartanInitial report10.11.2025Production problemValsartan STADA 160 mg film-coated tablets
AprepitantInitial report10.11.2025OtherEMEND 125 mg powder for oral suspension – OPXXXXmg
Amikacin sulfateChange notification10.11.2025Production problemAmikacin B. Braun 2.5 mg/ml solution for infusion
Amikacin sulfateChange notification10.11.2025Production problemAmikacin B. Braun 5 mg/ml solution for infusion
Tolterodine tartrateChange notification10.11.2025OtherDetrusitol 2 mg film-coated tablets
Ipratropium bromideChange notification10.11.2025Production problemIpratropium bromide 125 micrograms/1 ml Stulln
Duloxetine hydrochlorideInitial report10.11.2025OtherCymbalta 60 mg gastro-resistant hard capsules – OP28
2025年11月18日
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