BfArMボトルネック・レポート（2025年6月30日～7月6日）

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Active ingredients
Notification type
Date of last notificationType of reasonAM designation
FampridineChange notification04.07.2025OtherFampyra 10 mg prolonged-release tablets – OP28(2×14)(Bl)
Dexamethasone; neomycin sulfate; polymyxin B sulfateChange notification04.07.2025Production problemIsopto-Max
Olanzapine embonate monohydrateFirst notification04.07.2025Production problemZYPADHERA 210 mg powder and solvent for the preparation of a suspension for depot injection – OP(483mg+3ml)
Acetylcholine chlorideChange notification04.07.2025Production problemMiochol-E Powder and solvent for the preparation of an instillation solution for intraocular use
Terazosin hydrochloride dihydrateChange notification04.07.2025OtherHeitrin 1mg
Terazosin hydrochloride dihydrateChange notification04.07.2025OtherHeitrin 5mg
Terazosin hydrochloride dihydrateChange notification04.07.2025OtherHeitrin 2mg
NitrendipineChange notification04.07.2025Production problemNitrendipine Aristo 10 mg film-coated tablets
Rivastigmine hydrogentartrateChange notification04.07.2025Production problemRivastigmine Aurobindo 6 mg hard capsules
CelecoxibChange notification04.07.2025Production problemCelecoxib Aurobindo 200 mg hard capsules
Duloxetine hydrochlorideChange notification04.07.2025Production problemDuloxetine PUREN 40 mg enteric-coated hard capsules
Duloxetine hydrochlorideChange notification04.07.2025Production problemDuloxetine Aurobindo 60 mg enteric-coated hard capsules
Methylphenidate hydrochlorideChange notification03.07.2025Production problemMethysym
Methylphenidate hydrochlorideChange notification03.07.2025Production problemMethysym
Methylphenidate hydrochlorideChange notification03.07.2025Production problemMethysym
Methylphenidate hydrochlorideChange notification03.07.2025Production problemMethysym
Methylphenidate hydrochlorideChange notification03.07.2025Production problemMethysym
Methylphenidate hydrochlorideChange notification03.07.2025Production problemMethysym
Terazosin hydrochloride dihydrateChange notification03.07.2025OtherTera TAD 2mg
Terazosin hydrochloride dihydrateChange notification03.07.2025OtherTera TAD 5mg
Terazosin hydrochloride dihydrateChange notification03.07.2025OtherTera TAD 10mg
Cefotaxime sodiumFirst notification03.07.2025Production problemCefotaxime-saar 2 g Powder for solution for injection or infusion
Fluoxetine hydrochlorideFirst notification03.07.2025OtherFluoxetine beta 40
Fluoxetine hydrochlorideFirst notification03.07.2025OtherFluoxetine beta 20
Zoledronic acid monohydrateFirst notification03.07.2025OtherZole – 1 A Pharma 5 mg/100 ml solution for infusion
Zoledronic acid monohydrateFirst notification03.07.2025OtherAclasta 5 mg solution for infusion – OP(1x100ml)
Insulin human ((with manufacturing details))First notification03.07.2025OtherHuminsulin Profile III KwikPen 100 IU/ml injection suspension
Quetiapine fumarate (Ph.Eur.)First notification03.07.2025Production problemQuetiapine Glenmark 150 mg prolonged-release tablets
Mometasone furoate (Ph.Eur.)Change notification03.07.2025Production problemMometasone Glenmark 1mg/g ointment
UrapidilChange notification03.07.2025OtherUrapidil Stragen 30 mg delayed-release hard capsules
UrapidilChange notification03.07.2025OtherUrapidil Stragen 60 mg delayed-release hard capsules
Thioctic acid trometamol salt (1:1)Change notification03.07.2025OtherThioctacid 600 T
Solifenacin succinateChange notification03.07.2025Production problemSolifenacin succinate Aurobindo 5 mg film-coated tablets
Prednisolone acetateChange notification03.07.2025Production problemPredni-POS 1 %
FluorometholoneChange notification03.07.2025Production problemfluoropos
Hydrocortisone acetate (Ph.Eur.)Change notification03.07.2025Production problemHydrocortisone POS N 2.5%
Dexamethasone dihydrogen phosphate disodium (Ph.Eur.); gentamicin sulphateChange notification03.07.2025Production problemDexa-Gentamicin
AcyclovirChange notification03.07.2025Production problemVirupos
ClarithromycinChange notification03.07.2025Production problemCLARITHROMYCIN BASICS 250 mg/5 ml granules for the preparation of an oral suspension
Esomeprazole hemimagnesiumChange notification03.07.2025Production problemESOMEPRAZOL BASICS 40 mg gastro-resistant hard capsules
Esomeprazole hemimagnesiumChange notification03.07.2025Production problemESOMEPRAZOL BASICS 20 mg enteric-coated hard capsules
Insulin lisproFirst notification03.07.2025OtherLiprolog 100 E/ml solution for injection in cartridge – OP(5x3ml)
Anti-human T-lymphocyte immunoglobulin from horseFirst notification03.07.2025OtherAtgam
FluorouracilChange notification03.07.2025OtherBenda-5 FU
Vancomycin hydrochlorideChange notification03.07.2025Production problemVancomycin Lyomark 1000 mg powder for concentrate for solution for infusion or oral solution
Vancomycin hydrochlorideChange notification03.07.2025Production problemVancomycin Lyomark 500 mg
FluorouracilChange notification03.07.2025OtherFluorouracil Hikma 50 mg/ml solution for injection
Sodium (methylprednisolone-21-succinate)Change notification02.07.2025OtherUrbason solubile forte 1000 mg
Insulin glargineChange notification02.07.2025OtherSemglee
Salbutamol sulphateChange notification02.07.2025OtherSultanol metered dose aerosol
Insulin glargineFirst notification02.07.2025OtherSemglee 100 units/ml solution for injection in prefilled pen – OP(5x3ml)
Ampicillin sodiumChange notification02.07.2025Production problemAmpicillin Eberth 2 g powder for solution for injection/infusion
Ampicillin sodiumChange notification02.07.2025Production problemAmpicillin Eberth 500 mg powder for solution for injection/infusion
Fosfomycin sodium (Ph.Eur.)Change notification02.07.2025Production problemFosfomycin Eberth 2 g powder for solution for infusion
Fosfomycin sodium (Ph.Eur.)Change notification02.07.2025Production problemFosfomycin Eberth 4 g powder for solution for infusion
Epoetin betaFirst notification02.07.2025OtherNeoRecormon 3000 IU solution for injection in prefilled syringe – OP6
Ibandronate sodium monohydrateChange notification02.07.2025OtherBondronat 50 mg film-coated tablets – OP28
Methylphenidate hydrochlorideFirst notification02.07.2025OtherMethylphenidate AL 27 mg prolonged-release tablets
Ipratropium bromide (Ph.Eur.)Change notification02.07.2025Production problemIpratropium Teva 250 micrograms / 1 ml solution for nebulizer
BuprenorphineChange notification02.07.2025OtherBuprenorphine AWD Matrix 70 microgram/h transdermal patch
Fluoxetine hydrochlorideFirst notification02.07.2025Production problemFluoxetine Stada 20 mg tablets for oral suspension
RibavirinFirst notification02.07.2025OtherRibavirin-ratiopharm 400 mg film-coated tablets
RibavirinChange notification02.07.2025OtherRibavirin-ratiopharm 200 mg film-coated tablets
BuprenorphineChange notification02.07.2025OtherBuprenorphine-ratiopharm 70 microgram/h transdermal patch
BuprenorphineChange notification02.07.2025OtherBuprenorphine-ratiopharm 52.5 micrograms/h transdermal patch
BuprenorphineChange notification02.07.2025OtherBuprenorphine-ratiopharm 35 micrograms/h transdermal patch
AprepitantFirst notification02.07.2025Production problemAprepitant STADA 125 mg and 80 mg hard capsules
Rizatriptan benzoateChange notification01.07.2025Production problemRizatriptan Glenmark 5 mg tablets
Rizatriptan benzoateChange notification01.07.2025Production problemRizatriptan Glenmark 5 mg orodispersible tablets
Rizatriptan benzoateChange notification01.07.2025Production problemRizatriptan Glenmark 10 mg orodispersible tablets
Rizatriptan benzoateChange notification01.07.2025Production problemRizatriptan Glenmark 10 mg tablets
Quetiapine fumarate (Ph.Eur.)Change notification01.07.2025Production problemQuetiapine Glenmark 200 mg prolonged-release tablets
LinezolidChange notification01.07.2025Production problemLinezolid Glenmark 600 mg film-coated tablets
Galantamine hydrobromideChange notification01.07.2025Production problemGalantamine Glenmark 16 mg hard capsules, delayed release
Galantamine hydrobromideChange notification01.07.2025Production problemGalantamine Glenmark 8 mg hard capsules, delayed release
Galantamine hydrobromideChange notification01.07.2025Production problemGalantamine Glenmark 24 mg hard capsules, delayed-release
Trazodone hydrochlorideChange notification01.07.2025Production problemTrazodone Glenmark 100 mg tablets
Phenoxymethylpenicillin potassiumChange notification01.07.2025OtherPen Mega – 1 A Pharma
AprepitantChange notification01.07.2025OtherAprepilor 80 mg hard capsules
AprepitantChange notification01.07.2025OtherAprepilor 125 mg/80 mg hard capsules
Haloperidol decanoateChange notification01.07.2025Production problemHaloperidol-neuraxpharm decanoate 50 mg/ml
Haloperidol decanoateChange notification01.07.2025Production problemHaloperidol neuraxpharm decanoate 100 mg/ml
Quetiapine fumarate (Ph.Eur.)Change notification01.07.2025OtherQuetiapine-neuraxpharm 50 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification01.07.2025OtherQuetiapine-neuraxpharm 150 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification01.07.2025OtherQuetiapine-neuraxpharm 200 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification01.07.2025OtherQuetiapine-neuraxpharm 300 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification01.07.2025OtherQuetiapine-neuraxpharm 400 mg prolonged-release tablets
Quetiapine fumarate (Ph.Eur.)Change notification01.07.2025OtherQuetiapine-neuraxpharm 600 mg prolonged-release tablets
Galantamine hydrobromideChange notification01.07.2025OtherGalantamine-neuraxpharm 8 mg delayed-release hard capsules
Galantamine hydrobromideChange notification01.07.2025OtherGalantamine-neuraxpharm 16 mg hard capsules, prolonged-release
Galantamine hydrobromideChange notification01.07.2025OtherGalantamine-neuraxpharm 24 mg hard capsules, delayed-release
Atomoxetine hydrochlorideChange notification01.07.2025Production problemAtomoxetine-neuraxpharm 10 mg hard capsules
Paliperidone palmitateChange notification01.07.2025OtherPaliperidone AL 150 mg depot injection suspension in a prefilled syringe
Atomoxetine hydrochlorideChange notification01.07.2025Production problemAtomoxetine-neuraxpharm 18 mg hard capsules
Paliperidone palmitateChange notification01.07.2025OtherPaliperidone AL 75 mg depot injection suspension in a prefilled syringe
Atomoxetine hydrochlorideChange notification01.07.2025Production problemAtomoxetine-neuraxpharm 25 mg hard capsules
Paliperidone palmitateChange notification01.07.2025OtherPaliperidone AL 50 mg depot injection suspension in a prefilled syringe
Atomoxetine hydrochlorideChange notification01.07.2025Production problemAtomoxetine-neuraxpharm 40 mg hard capsules
Paliperidone palmitateChange notification01.07.2025OtherPaliperidone AL 25 mg depot injection suspension in a prefilled syringe
Atomoxetine hydrochlorideChange notification01.07.2025Production problemAtomoxetine-neuraxpharm 80 mg hard capsules
Atomoxetine hydrochlorideChange notification01.07.2025Production problemAtomoxetine-neuraxpharm 100 mg hard capsules
Pramipexole dihydrochloride monohydrateChange notification01.07.2025OtherPramipexole HEXAL 0.26 mg prolonged-release tablets
Methylphenidate hydrochlorideChange notification01.07.2025Production problemEquasym Retard 40 mg modified-release hard capsules
Tranexamic acidChange notification01.07.2025OtherCyklokapron
Mupirocin calcium (Ph.Eur.)Change notification30.06.2025Production problemTurixin
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification30.06.2025OtherAtorvastatin Micro Labs 10 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification30.06.2025OtherAtorvastatin Micro Labs 20 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification30.06.2025OtherAtorvastatin Micro Labs 30 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification30.06.2025OtherAtorvastatin Micro Labs 40 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification30.06.2025OtherAtorvastatin Micro Labs 60 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification30.06.2025OtherAtorvastatin Micro Labs 80 mg film-coated tablets
Ipratropium bromide (Ph.Eur.); salbutamol sulphateFirst notification30.06.2025Production problemCOMBIPRASAL 0.5 mg / 2.5 mg solution for nebulizer
Ipratropium bromideFirst notification30.06.2025Production problemIpratropium bromide 125 micrograms / 1 ml ampoule
Ipratropium bromideFirst notification30.06.2025Production problemIpratropium bromide 250 micrograms / 1 ml Stulln
Quetiapine fumarate (Ph.Eur.)Change notification30.06.2025OtherSeroquel Prolong 400 mg prolonged-release tablets
Sertraline hydrochlorideChange notification30.06.2025OtherSertraline TAD 100 mg film-coated tablets
Sertraline hydrochlorideChange notification30.06.2025OtherSertraline TAD 50 mg film-coated tablets
Trimipramine mesilateChange notification30.06.2025OtherTrimipramine – 1 A Pharma 40 mg/ml Oral drops, solution
Doxorubicin hydrochlorideChange notification30.06.2025OtherDoxorubicin HEXAL 2 mg/ml
Hydromorphone hydrochlorideChange notification30.06.2025OtherHydromorphone HEXAL 2.6 mg hard capsules
Terbutaline sulphate (Ph.Eur.)Change notification30.06.2025Production problemBRICANYL 0.5 mg
ChlortalidoneChange notification30.06.2025OtherChlortalidone HEXAL 25 mg tablets
ChlortalidoneChange notification30.06.2025OtherChlortalidone HEXAL 50 mg tablets
2025年7月7日
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