ドイツ

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  • 2026.02.16
    BfArMボトルネック・レポート（2月9日～2月15日）
    Active ingredients
    Message type
    		Date of last messageType of reasonAM designation
    Trimipramine mesylateChange notification13.02.2026OtherTrimipramine – 1 A Pharma 40 mg/ml oral drops, solution
    AlprazolamChange notification13.02.2026OtherAlprazolam – 1 A Pharma 0.5 mg tablets
    ChlortalidoneChange notification13.02.2026OtherChlortalidone HEXAL 12.5 mg tablets
    Dexketoprofen trometamolChange notification13.02.2026Production problemSympal inject 50 mg injection/infusion solution
    AnastrozoleChange notification13.02.2026Production problemAnastroPUREN 1 mg film-coated tablets
    IsoniazidChange notification13.02.2026OtherIsozid 100 mg
    Potassium iodide; levothyroxine sodiumChange notification13.02.2026OtherThyronajod 75 Henning
    Potassium iodide; levothyroxine sodiumInitial report13.02.2026OtherThyronajod 100 Henning
    Atorvastatin calcium trihydrate (Ph.Eur.)Initial report12.02.2026OtherATORVASTATIN BASICS 60 mg film-coated tablets
    Atorvastatin calcium trihydrate (Ph.Eur.)Change notification12.02.2026OtherATORVASTATIN BASICS 30 mg film-coated tablets
    Ciprofloxacin hydrochloride monohydrateInitial report12.02.2026OtherCIPRO BASICS 500 mg film-coated tablets
    Esomeprazole hemimagnesiumChange notification12.02.2026Production problemESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsules
    Candesartan cilexetilChange notification12.02.2026OtherCANDESARTAN BASICS 4 mg tablets
    Candesartan cilexetilChange notification12.02.2026OtherCANDESARTAN BASICS 8 mg tablets
    Candesartan cilexetilChange notification12.02.2026OtherCANDESARTAN BASICS 32 mg tablets
    Ciprofloxacin hydrochloride monohydrateChange notification12.02.2026OtherCIPRO BASICS 250 mg film-coated tablets
    Atorvastatin calcium trihydrate (Ph.Eur.)Initial report12.02.2026OtherATORVASTATIN BASICS 40 mg film-coated tablets
    Esomeprazole hemimagnesiumChange notification12.02.2026Production problemESOMEPRAZOLE BASICS 40 mg gastro-resistant hard capsules
    Tacrolimus monohydrateInitial report12.02.2026Production problemTacpan 5 mg hard capsules
    ZidovudineInitial report12.02.2026Production problemZidovudine Aurobindo 250 mg hard capsules
    Ondansetron hydrochloride dihydrateInitial report12.02.2026Production problemOndansetron Aurobindo 4 mg film-coated tablets
    Escitalopram oxalateInitial report12.02.2026OtherEscitalopram Aurobindo 10 mg film-coated tablets
    Duloxetine hydrochlorideInitial report12.02.2026OtherDuloxetine Aurobindo 60 mg gastro-resistant hard capsules
    Venlafaxine hydrochlorideInitial report12.02.2026Production problemVenlafaxine Aurobindo 75 mg hard capsule, delayed release
    Dutasteride; tamsulosin hydrochlorideInitial report12.02.2026Production problemDutasteride/tamsulosin PUREN 0.5 mg/0.4 mg hard capsules
    Deferoxamine mesylateInitial report12.02.2026Production problemDeferoxamine mesylate 2 g powder for solution for injection or infusion
    Amiodarone hydrochlorideInitial report12.02.2026Production problemAmiodarone Aurobindo 200 mg tablets
    Paliperidone palmitateChange notification12.02.2026OtherPaliperidone AL 25 mg depot injection suspension in a pre-filled syringe
    Dexamethasone acetate (Ph.Eur.); lidocaine hydrochloride monohydrateInitial report11.02.2026Production problemSupertendin 5
    Dexamethasone acetate (Ph.Eur.); lidocaine hydrochloride monohydrateInitial report11.02.2026Production problemSupertendin 10
    Lidocaine hydrochloride monohydrateChange notification10.02.2026OtherXylocaine Gel 2%
    EstriolInitial report10.02.2026OtherOvestin 1 mg tablets
    Sertraline hydrochlorideChange notification10.02.2026Production problemSertraline-neuraxpharm 200 mg film-coated tablets
    Sertraline hydrochlorideChange notification10.02.2026Production problemSertraline-neuraxpharm 150 mg film-coated tablets
    LevetiracetamChange notification10.02.2026Production problemLevetiracetam Holsten 750 mg film-coated tablets
    Human insulin ((with manufacturing details))Initial report09.02.2026OtherHuminsulin Basal (NPH) 100 100 IU/ml injection suspension in vial
    Thioctic acid trometamol salt (1:1)Change notification09.02.2026OtherThioctacid 600 T
    Prednisolone acetateChange notification09.02.2026Production problemPrednifluid 10 mg/ml eye drop suspension
    Terazosin hydrochloride dihydrateChange notification09.02.2026OtherHeitrin 5 mg
    Terazosin hydrochloride dihydrateChange notification09.02.2026OtherHeitrin 1mg
    Terazosin hydrochloride dihydrateChange notification09.02.2026OtherHeitrin 2 mg
    DapsonInitial report09.02.2026OtherDapsone Zentiva 50 mg tablets
    Mometasone furoate (Ph.Eur.)Change notification09.02.2026Production problemMomecutan solution
    IsoniazidChange notification09.02.2026OtherIsozid 50 mg
    Rifampicin sodiumChange notification09.02.2026OtherEremfat i.v. 600mg
  • 2026.02.09
    BfArMボトルネック・レポート（2月2日～2月8日）
    Active ingredients
    Message type
    		Date of last messageType of reasonAM designation
    Salbutamol sulfateInitial report08.02.2026OtherSultanol forte ready-to-use inhalation solution
    IsotretinoinChange notification06.02.2026OtherISOTRETINOIN BASICS 10 mg soft capsules
    IsotretinoinInitial report06.02.2026OtherISOTRETINOIN BASICS 20 mg soft capsules
    MitomycinChange notification06.02.2026OtherMitem 20mg
    Epoetin alfaInitial report06.02.2026OtherEpoetin alfa HEXAL 40000 IU/1 ml solution for injection in pre-filled syringe – OP6
    IvermectinChange notification06.02.2026OtherDRIPONIN 3 mg tablets
    OxcarbazepineChange notification06.02.2026OtherOxcarbazepine – 1 A Pharma 60 mg/ml oral suspension
    Pramipexole dihydrochloride monohydrateChange notification06.02.2026OtherPramipexole – 1 A Pharma 0.26 mg prolonged-release tablets
    Dexamethasone dihydrogen phosphate disodium (Ph.Eur.)Initial report05.02.2026OtherDexabene
    IbuprofenChange notification05.02.2026Production problemIbuprofen PUREN 600 mg film-coated tablets
    DocetaxelChange notification05.02.2026Production problemDocetaxel Aurobindo 20 mg/ml concentrate for solution for infusion
    Buprenorphine hydrochlorideChange notification05.02.2026OtherBuprenorphine PUREN 8 mg sublingual tablets
    AnastrozoleChange notification05.02.2026Production problemAnastroPUREN 1 mg film-coated tablets
    Quetiapine fumarate (Ph.Eur.)Change notification05.02.2026Production problemQuetiapine beta 150 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification05.02.2026Production problemQuetiapine beta 200 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification05.02.2026Production problemQuetiapine beta 300 mg prolonged-release tablets
    Atomoxetine hydrochlorideChange notification05.02.2026Production problemAtomoxetine beta 18 mg hard capsules
    Fluoxetine hydrochlorideChange notification05.02.2026OtherFluoxetine beta 20
    Atomoxetine hydrochlorideChange notification05.02.2026Production problemAtomoxetine beta 80 mg hard capsules
    AprepitantChange notification05.02.2026Production problemAprepitant beta 125 mg and 80 mg hard capsules
    Tacrolimus monohydrateInitial report04.02.2026OtherTakrozem 1 mg/g ointment
    Lidocaine hydrochloride monohydrateChange notification04.02.2026OtherXylocaine Gel 2%
    AlprostadilInitial report04.02.2026OtherProstavasin 20 µg
    GabapentinChange notification04.02.2026Production problemGabapentin Holsten 600 mg film-coated tablets
    Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y)Change notification04.02.2026OtherFerrlecit 40 mg
    RisperidoneChange notification04.02.2026Production problemRisperidone-ratiopharm 50 mg powder and solvent for the preparation of a depot injection suspension
    RisperidoneChange notification04.02.2026Production problemRisperidone-ratiopharm 37.5 mg powder and solvent for the preparation of a depot injection suspension
    RisperidoneChange notification04.02.2026Production problemRisperidone-ratiopharm 25 mg powder and solvent for the preparation of a depot injection suspension
    Candesartan cilexetilInitial report03.02.2026OtherATACAND 16 mg
    CrisantaspaseChange notification03.02.2026OtherErwinase 10,000 IU/vial powder for the preparation of an injection/infusion solution
    CalcitriolInitial report03.02.2026OtherRenatriol 0.25 µg
    CalcitriolInitial report03.02.2026OtherCalcitriol KyraMed 0.25 micrograms
    Fluoxetine hydrochlorideChange notification03.02.2026OtherFluoxetine Micro Labs 30 mg hard capsules
    Atorvastatin calcium trihydrate (Ph.Eur.)Change notification03.02.2026OtherAtorvastatin Micro Labs 60 mg film-coated tablets
    Prednisolone acetateInitial report03.02.2026Production problemPredni-POS 0.5%
    Propranolol hydrochlorideChange notification03.02.2026OtherPropra-ratiopharm 10 mg film-coated tablets
    Methylphenidate hydrochlorideInitial report03.02.2026OtherMethylphenidate-ratiopharm 30 mg modified-release hard capsules
    Methylphenidate hydrochlorideInitial report03.02.2026OtherMethylphenidate-ratiopharm 20 mg modified-release hard capsules
    Ipratropium bromide (Ph.Eur.)Change notification03.02.2026Production problemIpratropium Teva 250 micrograms/1 ml solution for nebulizer
    Quetiapine fumarate (Ph.Eur.)Change notification03.02.2026OtherQuetiapine AbZ 150 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification03.02.2026OtherQuetiapine-ratiopharm 300 mg prolonged-release tablets
    EverolimusChange notification03.02.2026OtherEverolimus-ratiopharm 5 mg tablets
    EverolimusChange notification03.02.2026OtherEverolimus-ratiopharm 2.5 mg tablets
    Doxepine hydrochloride (Ph.Eur.)Change notification03.02.2026OtherDoxepin-ratiopharm 25 mg film-coated tablets
    AlprazolamChange notification03.02.2026OtherAlprazolam-ratiopharm 1.0 mg tablets
    Prednisolone acetateChange notification03.02.2026Production problemPredni-POS 1%
    Proxymetacaine hydrochlorideChange notification03.02.2026Production problemProparacaine-POS 0.5%
    FluorometholoneChange notification03.02.2026Production problemFluoropos
    Gentamicin sulfateChange notification03.02.2026Production problemGentamicin-POS
    Salbutamol sulfateChange notification02.02.2026OtherBronchospray novo
  • 2026.02.02
    BfArMボトルネック・レポート（1月5日～2月1日）
    Active ingredients
    Message type
    		Date of last messageType of reasonAM designation
    Atomoxetine hydrochlorideChange notification30.01.2026OtherAtomoxe – 1 A Pharma 10 mg hard capsules
    Valaciclovir hydrochlorideChange notification30.01.2026OtherValaciclovir – 1A Pharma 500 mg film-coated tablets
    Salbutamol sulfateChange notification30.01.2026OtherSalbuHEXAL N metered-dose inhaler
    Salbutamol sulfateChange notification30.01.2026OtherSalbutamol – 1 A Pharma 0.1 mg pressurized gas inhalation, suspension
    LorazepamChange notification30.01.2026OtherTavor 2.5 mg Expidet
    Quetiapine fumarate (Ph.Eur.)Change notification30.01.2026Production problemQuetiapine – 1 A Pharma 600 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification30.01.2026Production problemQuetiapine – 1 A Pharma 50 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification30.01.2026Production problemQuetiapine – 1 A Pharma 300 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification30.01.2026Production problemQuetiapine – 1 A Pharma 200 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification30.01.2026Production problemQuetiapine – 1 A Pharma 150 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification30.01.2026Production problemQuetiapine HEXAL 50 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification30.01.2026Production problemQuetiapine HEXAL 400 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification30.01.2026Production problemQuetiapine HEXAL 200 mg prolonged-release tablets
    Methylphenidate hydrochlorideChange notification30.01.2026OtherMethylphenidate hydrochloride HEXAL 36 mg prolonged-release tablets
    LevetiracetamChange notification30.01.2026OtherLevetiracetam – 1 A Pharma 1500 mg film-coated tablets
    Ciprofloxacin hydrochloride (1:1) 1 H<2>OChange notification30.01.2026OtherCiprohexal 100 mg
    Ciprofloxacin hydrochloride (1:1) 1 H<2>OChange notification30.01.2026OtherCipro-1 A Pharma 100 mg
    Trimipramine mesylateChange notification30.01.2026OtherTrimipramine – 1 A Pharma 40 mg/ml Oral drops, solution
    OxytocinChange notification30.01.2026Production problemOxytocin 3 I.E. Hexal
    Insulin glargineChange notification30.01.2026OtherSemglee
    AlprazolamChange notification30.01.2026OtherAlprazolam – 1 A Pharma 0.5 mg tablets
    ChlortalidoneChange notification30.01.2026OtherChlortalidone HEXAL 12.5 mg tablets
    DinoprostoneChange notification30.01.2026OtherPropess 10 mg vaginal delivery system
    RifampicinChange notification30.01.2026Production problemEremfat syrup
    Ezetimibe; simvastatinChange notification30.01.2026Production problemEZETIMIB/SIMVA BASICS 10 mg/80 mg tablets
    Ezetimibe; simvastatinChange notification30.01.2026Production problemEZETIMIB/SIMVA BASICS 10 mg/40 mg tablets
    Ezetimibe; simvastatinChange notification30.01.2026Production problemEZETIMIB/SIMVA BASICS 10 mg/20 mg tablets
    Ezetimibe; simvastatinChange notification30.01.2026Production problemEZETIMIB/SIMVA BASICS 10 mg/10 mg tablets
    Ciprofloxacin hydrochloride monohydrateChange notification30.01.2026OtherCIPRO BASICS 750 mg film-coated tablets
    Ciprofloxacin hydrochloride monohydrateChange notification30.01.2026OtherCIPRO BASICS 250 mg film-coated tablets
    Atorvastatin calcium trihydrate (Ph.Eur.)Change notification30.01.2026OtherATORVASTATIN BASICS 30 mg film-coated tablets
    Atorvastatin calcium trihydrate (Ph.Eur.)Change notification30.01.2026OtherATORVASTATIN BASICS 20 mg film-coated tablets
    Atorvastatin calcium trihydrate (Ph.Eur.)Change notification30.01.2026OtherATORVASTATIN BASICS 10 mg film-coated tablets
    Atorvastatin calcium trihydrate (Ph.Eur.)Change notification30.01.2026OtherATORVASTATIN BASICS 80 mg film-coated tablets
    Candesartan cilexetilChange notification30.01.2026OtherCANDESARTAN BASICS 32 mg tablets
    Candesartan cilexetilChange notification30.01.2026OtherCANDESARTAN BASICS 16 mg tablets
    Candesartan cilexetilChange notification30.01.2026OtherCANDESARTAN BASICS 8 mg tablets
    Candesartan cilexetilChange notification30.01.2026OtherCANDESARTAN BASICS 4 mg tablets
    Esomeprazole hemimagnesiumChange notification30.01.2026Production problemESOMEPRAZOLE BASICS 40 mg gastro-resistant hard capsules
    Esomeprazole hemimagnesiumChange notification30.01.2026Production problemESOMEPRAZOLE BASICS 20 mg gastro-resistant hard capsules
    Quetiapine fumarate (Ph.Eur.)Initial report30.01.2026OtherSeroquel Prolong 400 mg prolonged-release tablets
    Clonidine hydrochlorideInitial report29.01.2026OtherCatapresan 300
    Pramipexole dihydrochloride monohydrateChange notification29.01.2026OtherPramipexole-ratiopharm 0.52 mg prolonged-release tablets
    Folic acid hydrate (with information on water content (1:x))Initial report29.01.2026Production problemFolsan 0.4 mg
    Methyldopa (Ph.Eur.)Initial report29.01.2026Production problemPresinol 500
    PrednicarbatInitial report29.01.2026OtherPrednitop Crinale
    Mometasone furoate (Ph.Eur.)Change notification29.01.2026Production problemMomecutan solution
    Imatinib mesylateInitial report28.01.2026OtherImatinib Denk 100 mg film-coated tablets
    Amlodipine besylate; Perindopril tert-butylamineChange notification28.01.2026OtherPerindopril/Amlodipine Denk 4 mg/10 mg tablets
    Amlodipine besylate; Perindopril tert-butylamineChange notification28.01.2026OtherPerindopril/Amlodipine Denk 8 mg/10 mg tablets
    Rifampicin sodiumChange notification28.01.2026OtherEremfat i.v. 600mg
    Quetiapine fumarate (Ph.Eur.)Change notification28.01.2026OtherQuetiapine AL 50 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification28.01.2026OtherQuetiapine AL 150 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification28.01.2026OtherQuetiapine AL 300 mg prolonged-release tablets
    AprepitantChange notification28.01.2026OtherAprepitant AL 80 mg hard capsules
    AprepitantChange notification28.01.2026OtherAprepitant AL 125 mg hard capsules
    NitrendipineChange notification28.01.2026OtherNitrendipine AL 20
    NitrendipineChange notification28.01.2026OtherNitrendipine AL 10
    Methylphenidate hydrochlorideChange notification28.01.2026OtherMETHYLPHENIDATE 20 mg tablets
    Thioctic acid trometamol salt (1:1)Initial report28.01.2026OtherThioctacid 600 T
    Duloxetine hydrochlorideInitial report27.01.2026Production problemDuloxetine Zentiva 30 mg gastro-resistant hard capsules
    Duloxetine hydrochlorideInitial report27.01.2026Production problemDuloxetine Zentiva 60 mg gastro-resistant hard capsules
    Doxepin hydrochloride (Ph.Eur.)Change notification27.01.2026OtherDoxepin 50 Holsten
    GabapentinChange notification27.01.2026OtherGabapentin Holsten 100 mg hard capsules
    Moxifloxacin hydrochloride (Ph.Eur.) ((with information on water content (1:x)))Change notification27.01.2026OtherMoxifloxacin Holsten 400 mg film-coated tablets
    Atomoxetine hydrochlorideChange notification27.01.2026Production problemAtomoxetine-neuraxpharm 100 mg hard capsules
    Atomoxetine hydrochlorideChange notification27.01.2026Production problemAtomoxetine-neuraxpharm 80 mg hard capsules
    Atomoxetine hydrochlorideChange notification27.01.2026Production problemAtomoxetine-neuraxpharm 40 mg hard capsules
    Atomoxetine hydrochlorideChange notification27.01.2026Production problemAtomoxetine-neuraxpharm 25 mg hard capsules
    Atomoxetine hydrochlorideChange notification27.01.2026Production problemAtomoxetine-neuraxpharm 18 mg hard capsules
    Atomoxetine hydrochlorideChange notification27.01.2026Production problemAtomoxetine-neuraxpharm 10 mg hard capsules
    Atomoxetine hydrochlorideChange notification27.01.2026Production problemAtomoxetine-neuraxpharm 60 mg hard capsules
    Atorvastatin calcium trihydrate (Ph.Eur.)Change notification26.01.2026OtherAtorvastatin Micro Labs 60 mg film-coated tablets
    Atorvastatin calcium trihydrate (Ph.Eur.)Change notification26.01.2026OtherAtorvastatin Micro Labs 30 mg film-coated tablets
    Fluoxetine hydrochlorideChange notification26.01.2026OtherFluoxetine Micro Labs 60 mg hard capsules
    Fluoxetine hydrochlorideChange notification26.01.2026OtherFluoxetine Micro Labs 30 mg hard capsules
    Naloxone hydrochloride dihydrate; oxycodone hydrochloride (Ph.Eur.)Change notification26.01.2026Production problemTargin 40 mg/20 mg prolonged-release tablets
    ZonisamideChange notification26.01.2026Production problemZonisamide Glenmark 100 mg hard capsules
    Levofloxacin hemihydrateChange notification26.01.2026Production problemLevofloxacin Kabi 5 mg/ml solution for infusion
    Ciprofloxacin sulfate (1:1)Change notification26.01.2026Production problemCiprofloxacin Kabi 200 mg/100 ml solution for infusion
    Rizatriptan benzoateChange notification26.01.2026Production problemRizatriptan Glenmark 5 mg tablets
    Rizatriptan benzoateChange notification26.01.2026Production problemRizatriptan Glenmark 5 mg orodispersible tablets
    Quetiapine fumarate (Ph.Eur.)Initial report26.01.2026Production problemQuetiapine Glenmark 50 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification26.01.2026Production problemQuetiapine Glenmark 150 mg prolonged-release tablets
  • 2026.01.26
    BfArMボトルネック・レポート（1月19日～1月25日）
    Active ingredients
    Message type
    		Date of last messageType of reasonAM designation
    Quetiapine fumarate (Ph.Eur.)Change notification23.01.2026Production problemQuetiapine Glenmark 200 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification23.01.2026Production problemQuetiapine Glenmark 400 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification23.01.2026Production problemQuetiapine Glenmark 150 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification23.01.2026Production problemQuetiapine Glenmark 300 mg prolonged-release tablets
    Rifampicin sodiumChange notification23.01.2026OtherEremfat i.v. 300mg
    IvermectinChange notification23.01.2026OtherDRIPONIN 3 mg tablets
    Galantamine hydrobromideChange notification23.01.2026Production problemGalantamine Glenmark 8 mg hard capsules, delayed release
    Galantamine hydrobromideChange notification23.01.2026Production problemGalantamine Glenmark 24 mg hard capsules, delayed release
    Galantamine hydrobromideChange notification23.01.2026Production problemGalantamine Glenmark 16 mg hard capsules, delayed release
    Fibrinogen, humanChange notification23.01.2026OtherFibryga
    IsoniazidInitial report23.01.2026OtherIsozid 50 mg
    Mannitol (Ph.Eur.)Change notification23.01.2026OtherBronchitol 40 mg hard capsule with powder for inhalation – OP10(1×10)
    Dexketoprofen trometamolChange notification23.01.2026Production problemSympal inject 50 mg solution for injection/infusion
    Valaciclovir hydrochlorideInitial report22.01.2026OtherValaciclovir – 1A Pharma 500 mg film-coated tablets
    Valaciclovir hydrochlorideInitial report22.01.2026OtherValaciclovir – 1A Pharma 1000 mg film-coated tablets
    Fluoxetine hydrochlorideChange notification22.01.2026OtherFluoxetine Micro Labs 30 mg hard capsules
    Clomipramine hydrochlorideChange notification22.01.2026Production problemAnafranil 75 mg retard
    Ropivacaine hydrochloride monohydrateInitial report21.01.2026Production problemNAROPIN 10mg/ml Amp.10ml Solution for injection
    Ropivacaine hydrochloride monohydrateInitial report21.01.2026OtherNAROPIN 2 mg/ml Amp. 20 ml Solution for injection
    Quetiapine fumarate (Ph.Eur.)Change notification21.01.2026OtherSeroquel Prolong 200 mg prolonged-release tablets
    Epirubicin hydrochlorideChange notification21.01.2026Production problemEpirubicin Hikma 2 mg/ml concentrate for solution for infusion
    Vancomycin hydrochlorideChange notification21.01.2026OtherVancomycin CP 500mg
    Lidocaine hydrochloride monohydrateChange notification21.01.2026OtherXylocaine Gel 2%
    Cyclophosphamide monohydrateInitial report21.01.2026Production problemEndoxan 200 mg
    Cyclophosphamide monohydrateInitial report21.01.2026Production problemEndoxan 500 mg
    Cyclophosphamide monohydrateInitial report21.01.2026Production problemEndoxan 1 g
    IfosfamideInitial report21.01.2026Production problemHoloxan
    Phenobarbital sodiumChange notification20.01.2026OtherLuminal injection solution
    Salbutamol sulfateInitial report20.01.2026OtherBronchospray Autohaler
    LorazepamChange notification20.01.2026OtherTavor 2.5 mg Expidet
    Epinephrine/AdrenalineChange notification20.01.2026Production problemAnapen 500 micrograms solution for injection
    Insulin glargineChange notification20.01.2026OtherSemglee
    Insulin glargineChange notification20.01.2026OtherSemglee 100 units/ml solution for injection in pre-filled pen – OP (5x3ml)
    Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y)Change notification20.01.2026OtherFerrlecit 40 mg
    Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y)Change notification20.01.2026OtherFerrlecit 62.5 mg
    Tamsulosin hydrochlorideChange notification20.01.2026OtherTamsulosin hydrochloride PUREN 0.4 mg prolonged-release capsules
    PregabalinChange notification20.01.2026OtherPregabalin Aurobindo 25 mg hard capsules
    Buprenorphine hydrochlorideChange notification20.01.2026OtherBuprenorphine PUREN 8 mg sublingual tablets
    Atorvastatin calcium trihydrate (Ph.Eur.)Change notification20.01.2026OtherAtorvastatin PUREN 40 mg film-coated tablets
    Rosuvastatin calcium (Ph.Eur.)Change notification20.01.2026OtherRosuvastatin Aurobindo 20 mg film-coated tablets
    AnastrozoleChange notification20.01.2026OtherAnastrozole Denk 1 mg film-coated tablets
    Propranolol hydrochlorideInitial report19.01.2026OtherDOCITON 10mg
    NitrendipineInitial report19.01.2026OtherNitrendipine Aristo 10 mg film-coated tablets
    Arsenic(III) oxideChange notification19.01.2026OtherTRISENOX 2 mg/ml concentrate for solution for infusion
    DinoprostInitial report19.01.2026OtherPropess 10 mg vaginal delivery system
    AdalimumabChange notification19.01.2026OtherAmsparity
    AdalimumabChange notification19.01.2026OtherAmsparity
    Methanthelinium bromideInitial report19.01.2026Production problemVagantin RIEMSER
    Betamethasone dipropionate (Ph.Eur.); salicylic acidInitial report19.01.2026OtherSoderm plus solution 0.64 mg/g + 20 mg/g solution for application to the skin
  • 2026.01.19
    BfArMボトルネック・レポート（1月12日～1月18日）
    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
  • 2026.01.12
    BfArMボトルネック・レポート（1月5日～1月11日）
    Active ingredients
    Message type
    		Date of last messageType of reasonAM designation
    Human fibrinogenChange notification11.01.2026OtherFibCLOT
    Trimipramine mesylateChange notification09.01.2026OtherTrimipramine – 1 A Pharma 40 mg/ml oral drops, solution
    Etoposide phosphateInitial report09.01.2026Production problemEtopophos 1000 mg, powder for solution for infusion
    VandetanibInitial report09.01.2026OtherCaprelsa 300 mg film-coated tablets – OP30
    Phenobarbital sodiumInitial report09.01.2026OtherLuminal solution for injection
    LevetiracetamInitial report09.01.2026OtherKeppra 100 mg/ml oral solution – OP (1x150ml)
    Morphine hemisulfate 2.5 hydrateInitial report09.01.2026Production problemSubstitol 60 mg hard capsule, delayed release
    Erythromycin lactobionateInitial report09.01.2026Production problemErythromycin Inresa i.v. 1g
    Lidocaine hydrochloride monohydrateChange notification09.01.2026OtherXylocaine Gel 2%
    Mometasone furoate (Ph.Eur.)Initial report09.01.2026Production problemMomecutan solution
    Insulin aspartInitial report09.01.2026OtherNovoRapid 100 E/ml solution for injection in vial – OP[5x(1x10ml)]
    Pramipexole dihydrochloride monohydrateChange notification09.01.2026OtherPramipexole – 1 A Pharma 0.26 mg prolonged-release tablets
    AprepitantChange notification09.01.2026OtherEMEND 125 mg powder for oral suspension – OPXXXXmg
    OxytocinChange notification09.01.2026Production problemOxytocin 3 IU Hexal
    Metamizole sodium monohydrateChange notification09.01.2026Production problemNovaminsulfon – 1 A Pharma Drops
    DigoxinChange notification08.01.2026Production problemLanicor
    MethylprednisoloneChange notification08.01.2026Production problemUrbason 16 mg tablets
    (RS)-2,3-Bis(sulfanyl)propane-1-sulfonic acid sodium salt monohydrateInitial report08.01.2026Production problemDimaval
    Epoetin thetaInitial report08.01.2026OtherEporatio 5000 IU/0.5 ml injection solution in pre-filled syringe – OP (6×0.5 ml)
    Insulin aspartChange notification08.01.2026OtherKirsty 100 units/ml solution for injection in a pre-filled pen
    Insulin aspartChange notification08.01.2026OtherKirsty 100 units/ml solution for injection in a pre-filled pen
    Doxycycline monohydrateInitial report08.01.2026OtherDoxycycline AL 200
    DinoprostoneInitial report08.01.2026OtherPrepidil Gel
    Fusidic acid (Ph.Eur.)Change notification08.01.2026Production problemFucithalmic 10 mg/g eye drops
    IndomethacinInitial report08.01.2026OtherIndomethacin AL 50
    Oxycodone hydrochloride (Ph.Eur.)Change notification08.01.2026Production problemOxygesic injection 10 mg/ml
    Lanreotide acetate (1:x) ((with information on acetic acid content))Change notification08.01.2026Production problemMytolac 120 mg solution for injection in a pre-filled syringe
    Lanreotide acetate (1:x) ((with information on acetic acid content))Change notification08.01.2026Production problemMytolac 90 mg solution for injection in a pre-filled syringe
    RisperidoneChange notification08.01.2026Production problemRisperidone-ratiopharm 25 mg powder and solvent for the preparation of a prolonged-release injection suspension
    RisperidoneChange notification08.01.2026Production problemRisperidone-ratiopharm 37.5 mg powder and solvent for the preparation of a prolonged-release injection suspension
    RisperidoneChange notification08.01.2026Production problemRisperidone-ratiopharm 50 mg powder and solvent for the preparation of a depot injection suspension
    Sodium (methylprednisolone-21-succinate)Change notification07.01.2026OtherUrbason solubile forte 1000 mg
    Paliperidone palmitateInitial report07.01.2026Production problemPaliperidone Advanz Pharma 150 mg depot injection suspension in a pre-filled syringe
    Paliperidone palmitateInitial report07.01.2026Production problemPaliperidone Advanz Pharma 100 mg Depot injection suspension in a pre-filled syringe
    Paliperidone palmitateChange notification07.01.2026Production problemPaliperidone Advanz Pharma 25 mg prolonged-release suspension for injection in a pre-filled syringe
    Paliperidone palmitateChange notification07.01.2026Production problemPaliperidone Advanz Pharma 50 mg prolonged-release suspension for injection in a pre-filled syringe
    Paliperidone palmitateChange notification07.01.2026Production problemPaliperidone Advanz Pharma 75 mg depot injection suspension in a pre-filled syringe
    AlbendazoleInitial report07.01.2026OtherEskazole
    LamotrigineInitial report07.01.2026OtherLamictal 5 mg tablets for the preparation of an oral suspension or chewable tablets
    Disodium pamidronateInitial report07.01.2026Production problemPAMIDRO-cell 3 mg/ml concentrate for solution for infusion
    Biperiden hydrochlorideChange notification07.01.2026Production problemBiperiden-neuraxpharm 4 mg
    Biperiden hydrochlorideChange notification07.01.2026Production problemBiperiden-neuraxpharm 2 mg
    Galantamine hydrobromideChange notification07.01.2026OtherGalantamine-neuraxpharm 8 mg hard capsules, delayed release
    Galantamine hydrobromideChange notification07.01.2026OtherGalantamine-neuraxpharm 16 mg Hard capsules, delayed release
    Galantamine hydrobromideChange notification07.01.2026OtherGalantamine-neuraxpharm 24 mg hard capsules, delayed release
    Cisatracurium besylateChange notification07.01.2026OtherNimbex 5mg
    Doxorubicin hydrochlorideChange notification07.01.2026Production problemDoxorubicin hydrochloride Bendalis 2 mg/ml
    FluorouracilChange notification07.01.2026OtherBenda-5 FU
    Somatostatin acetateChange notification07.01.2026Production problemSomatostatin 3 mg Inresa
    DeferasiroxChange notification06.01.2026OtherDeferasirox Mylan 180 mg film-coated tablets
    Tenofovir disoproxilChange notification06.01.2026OtherTenofovir disoproxil Viatris 245 mg film-coated tablets – OP30
    Tenofovir disoproxilChange notification06.01.2026OtherTenofovir disoproxil Mylan 245 mg film-coated tablets – OP90(3×30)
    Hydrochlorothiazide; ValsartanChange notification06.01.2026OtherVALSARTAN COMP BASICS 160 mg/25 mg film-coated tablets
    Hydrochlorothiazide; ValsartanChange notification06.01.2026OtherVALSARTAN COMP BASICS 80 mg/12.5 mg film-coated tablets
    Hydrochlorothiazide; ValsartanChange notification06.01.2026OtherVALSARTAN COMP BASICS 160 mg/12.5 mg film-coated tablets
    Beclomethasone dipropionate (Ph.Eur.); formoterol fumarate dihydrate (Ph.Eur.); glycopyrronium bromide (Ph.Eur.)Initial report06.01.2026Production problemTrimbow 87 micrograms/5 micrograms/9 micrograms pressurized gas inhalation, solution – OP360 cans (3×120 cans)
    AprepitantChange notification05.01.2026Production problemAprepitant beta 125 mg and 80 mg hard capsules
    Atomoxetine hydrochlorideChange notification05.01.2026Production problemAtomoxetine beta 80 mg hard capsules
    AprepitantChange notification05.01.2026Production problemAprepitant beta 80 mg hard capsules
    Fluoxetine hydrochlorideChange notification05.01.2026OtherFluoxetine beta 20
    PenicillamineChange notification05.01.2026Production problemMetalcaptase 150 mg
    Iron(III) hexacyanoferrate(II)Change notification05.01.2026OtherThallium antidote
    Rivastigmine hydrogen tartrateChange notification05.01.2026Production problemRivastigmine Aurobindo 6 mg hard capsules
    Insulin lisproInitial report05.01.2026OtherLiprolog 200 units/ml solution for injection in pre-filled pen – OP[2x(5x3ml)]
    Hydromorphone hydrochlorideChange notification05.01.2026OtherHydromorphone HCl PUREN 4 mg hard capsules, delayed release
    Escitalopram oxalateChange notification05.01.2026OtherEscitalopram Aurobindo 10 mg film-coated tablets
    Flucloxacillin sodium 1 H<2>OChange notification05.01.2026Production problemStaphylex 250 mg capsules
    Moxifloxacin hydrochloride (Ph.Eur.) ((with information on water content (1:x)))Change notification05.01.2026OtherMoxifloxacin Holsten 400 mg film-coated tablets
    Insulin lisproInitial report05.01.2026OtherLiprolog 100 E/ml KwikPen solution for injection – OP[2x(5x3ml)]
    Clomipramine hydrochlorideChange notification05.01.2026Production problemAnafranil 75mg retard
    Quetiapine fumarate (Ph.Eur.)Change notification05.01.2026OtherSeroquel Prolong 150 mg prolonged-release tablets
    Amlodipine besylate; Perindopril tert-butylamineChange notification05.01.2026Production problemPerindopril/amlodipine Denk 8 mg/5 mg tablets
    Gentamicin sulfateChange notification05.01.2026Production problemGentamicin-POS
    Phenylephrine hydrochlorideChange notification05.01.2026Production problemNeosynephrine-POS 5%
    Minocycline hydrochloride dihydrate (Ph.Eur.)Change notification05.01.2026Production problemSkid 50 mg
    Minocycline hydrochloride dihydrate (Ph.Eur.)Change notification05.01.2026Production problemSkid 100 mg
    Quetiapine fumarate (Ph.Eur.)Change notification05.01.2026OtherQuetiapine Hormosan 300 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification05.01.2026OtherQuetiapine Hormosan 400 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification05.01.2026OtherQuetiapine-Hormosan 200 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification05.01.2026OtherQuetiapine-Hormosan 150 mg prolonged-release tablets
    Oxycodone hydrochloride (Ph.Eur.)Change notification05.01.2026OtherOxycan uno 10 mg prolonged-release tablets
  • 2026.01.04
    BfArMボトルネック・レポート（2025年12月22日～2026年1月4日）
    Active ingredients
    Message type
    		Date of last messageType of reasonAM designation
    BCG bacteria, strain TICE, live, attenuatedChange notification02.01.2026OtherOncoTICE
    Salbutamol sulfateChange notification02.01.2026OtherSalbuHEXAL N Metered dose inhaler
    Salbutamol sulfateChange notification02.01.2026OtherSalbutamol – 1 A Pharma 0.1 mg pressurized gas inhalation, suspension
    Epoetin thetaInitial report02.01.2026OtherEporatio 10,000 IU/1 ml injection solution in pre-filled syringe – OP (6x1ml)
    Epoetin thetaInitial report02.01.2026OtherEporatio 4000 IU/0.5 ml injection solution in pre-filled syringe – OP (6×0.5 ml)
    DigoxinInitial report30.12.2025Production problemLanicor
    TeicoplaninChange notification29.12.2025OtherTeicoplanin Eberth 200 mg powder for solution for injection/infusion or oral solution
    TeicoplaninChange notification29.12.2025OtherTeicoplanin Eberth 400 mg powder for solution for injection/infusion or oral solution
    EtanerceptInitial report29.12.2025OtherNepexto 50 mg solution for injection in a pre-filled syringe
    Insulin glargineChange notification29.12.2025OtherSemglee 100 units/ml solution for injection in a pre-filled pen – OP(5x3ml)
    Insulin glargineChange notification29.12.2025OtherSemglee
    Lanreotide acetate (1:x) ((with information on acetic acid content))Change notification29.12.2025Production problemMytolac 60 mg solution for injection in a pre-filled syringe
    Fosfomycin sodium (Ph.Eur.)Change notification23.12.2025Production problemFosfomycin Eberth 2 g powder for solution for infusion
    Fosfomycin sodium (Ph.Eur.)Change notification23.12.2025Production problemFosfomycin Eberth 4 g powder for solution for infusion
    Galantamine hydrobromideChange notification23.12.2025Production problemGalantamine Heumann 24 mg hard capsules, delayed release
    Galantamine hydrobromideChange notification23.12.2025Production problemGalantamine Heumann 16 mg hard capsules, delayed release
    Galantamine hydrobromideChange notification23.12.2025Production problemGalantamine Heumann 8 mg hard capsules, delayed release
    Quetiapine fumarate (Ph.Eur.)Change notification23.12.2025Production problemQuetiapine Heumann retard 300 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification23.12.2025Production problemQuetiapine Heumann retard 400 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification23.12.2025Production problemQuetiapine Heumann retard 50 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification23.12.2025Production problemQuetiapine Heumann retard 150 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification23.12.2025Production problemQuetiapine Heumann retard 200 mg prolonged-release tablets
    Oxycodone hydrochloride (Ph.Eur.)Initial report22.12.2025Production problemOxygesic injection 10 mg/ml
    Morphine hemisulfate 2.5 hydrateInitial report22.12.2025Production problemMSI 10 mg Mundipharma
    Oxycodone hydrochlorideInitial report22.12.2025Production problemOxygesic 80 mg
    AdalimumabChange notification22.12.2025OtherAmsparity
    AdalimumabChange notification22.12.2025OtherAmsparity
    FluconazoleChange notification22.12.2025OtherFlucoderm capsules 50 mg
    Lidocaine hydrochloride monohydrateChange notification22.12.2025OtherXylocaine Gel 2%
    HydrocortisoneInitial report22.12.2025OtherHydrocutan cream 1%
    Fusidic acid (Ph.Eur.)Change notification22.12.2025OtherFusicutan ointment
    ImiquimodChange notification22.12.2025Production problemImikeraderm 50 mg/g cream
    Cefaclor monohydrateChange notification22.12.2025OtherCefaclor 125 TS – 1 A Pharma
  • 2025.12.22
    BfArMボトルネック・レポート（2025年12月15日～12月21日）
    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
  • 2025.12.15
    BfArMボトルネック・レポート（2025年12月8日～12月14日）
    Active ingredients
    Message type
    		Date of last messageType of reasonAM designation
    Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y)Change notification12.12.2025OtherFerrlecit 40 mg
    Clomipramine hydrochlorideInitial report12.12.2025OtherClomipramine-neuraxpharm 75 mg retard
    Epoetin zetaInitial report12.12.2025OtherRetacrit 40,000 IU/1 ml solution for injection in pre-filled syringe
    Epoetin zetaInitial report12.12.2025OtherRetacrit 40,000 IU/1 ml solution for injection in pre-filled syringe
    Atorvastatin calcium trihydrate (Ph.Eur.)Initial report11.12.2025OtherAtorvastatin Micro Labs 10 mg film-coated tablets
    Atorvastatin calcium trihydrate (Ph.Eur.)Change notification11.12.2025OtherAtorvastatin Micro Labs 30 mg film-coated tablets
    Atorvastatin calcium trihydrate (Ph.Eur.)Change notification11.12.2025OtherAtorvastatin Micro Labs 60 mg film-coated tablets
    Fluoxetine hydrochlorideChange notification11.12.2025OtherFluoxetine Micro Labs 60 mg hard capsules
    Fluoxetine hydrochlorideChange notification11.12.2025OtherFluoxetine Micro Labs 30 mg hard capsules
    Quetiapine fumarate (Ph.Eur.)Change notification11.12.2025OtherQuetiapine AL 200 mg prolonged-release tablets
    PrednicarbateChange notification11.12.2025OtherPrednicarbate acis solution
    Zoledronic acid monohydrateInitial report11.12.2025OtherZoledronic acid AL 4 mg/100 ml infusion solution
    Ibandronate sodium monohydrateInitial report11.12.2025OtherIbandronic acid AL 3 mg solution for injection in a pre-filled syringe
    Fibrinogen, humanInitial report10.12.2025OtherFibryga
    Sodium (hydrocortisone-21-succinate)Change notification10.12.2025Production problemHydrocortisone PANPHARMA 100 mg
    Methylphenidate hydrochlorideChange notification10.12.2025OtherCONCERTA 54 mg prolonged-release tablets
    Methylphenidate hydrochlorideChange notification10.12.2025OtherCONCERTA 36 mg prolonged-release tablets
    Methylphenidate hydrochlorideChange notification10.12.2025OtherCONCERTA 27 mg prolonged-release tablets
    Methylphenidate hydrochlorideChange notification10.12.2025OtherCONCERTA 18 mg prolonged-release tablets
    DimenhydrinateInitial report10.12.2025Production problemDimenhydrinate PANPHARMA 6.2 mg/ml solution for injection (i.v.)
    Metformin hydrochlorideInitial report10.12.2025OtherMetformin 500 – 1 A Pharma
    Candesartan cilexetilInitial report10.12.2025OtherBlopress 16 mg
    Colistimethate sodiumInitial report10.12.2025Production problemColistin CF
    RisperidoneChange notification10.12.2025Production problemRisperidone-ratiopharm 50 mg powder and solvent for the preparation of a depot injection suspension
    RisperidoneChange notification10.12.2025Production problemRisperidone-ratiopharm 37.5 mg powder and solvent for the preparation of a depot injection suspension
    RisperidoneChange notification10.12.2025Production problemRisperidone-ratiopharm 25 mg powder and solvent for the preparation of a depot injection suspension
    RibavirinChange notification10.12.2025Production problemRibavirin-ratiopharm 200 mg film-coated tablets
    RibavirinChange notification10.12.2025OtherRibavirin-ratiopharm 400 mg film-coated tablets
    Levothyroxine sodiumInitial report10.12.2025OtherL-thyroxine-Na-ratiopharm 50 microgram tablets
    Levothyroxine sodiumInitial report10.12.2025OtherL-Thyroxine-Na-ratiopharm 25 microgram tablets
    Isoniazid; pyridoxine hydrochlorideInitial report09.12.2025OtherIsozid comp. 200 mg N
    IsoniazidInitial report09.12.2025OtherIsozid 0.5 N
    PyrazinamideInitial report09.12.2025Production problemPyrafat 500mg
    DapsoneInitial report09.12.2025Production problemDapson-Fatol
    FilgrastimInitial report09.12.2025OtherNivestim 12 million E/0.2 ml injection/infusion solution – OP (5×0.2 ml)
    AdalimumabInitial report09.12.2025OtherAmsparity
    AdalimumabInitial report09.12.2025OtherAmsparity
    AdalimumabInitial report09.12.2025OtherAmsparity
    AdalimumabInitial report09.12.2025OtherAmsparity
    Risedronate sodium 2.5 hydrate (Ph.Eur.)Initial report09.12.2025OtherRisedronate Aurobindo once weekly 35 mg film-coated tablets
    Terazosin hydrochloride dihydrateChange notification09.12.2025OtherHeitrin 1mg
    Terazosin hydrochloride dihydrateChange notification09.12.2025OtherHeitrin 5mg
    Terazosin hydrochloride dihydrateChange notification09.12.2025OtherHeitrin 2 mg
    Metamizole sodium monohydrateInitial report08.12.2025Production problemNovaminsulfon – 1 A Pharma Drops
    Methylphenidate hydrochlorideInitial report08.12.2025OtherEquasym Retard 40 mg hard capsules with modified release
    Atorvastatin calcium trihydrate (Ph.Eur.)Initial report08.12.2025OtherAtorvastatin – 1A Pharma 40 mg film-coated tablets
    Atorvastatin calcium trihydrate (Ph.Eur.)Initial report08.12.2025OtherAtorvastatin – 1A Pharma 10 mg film-coated tablets
    Quetiapine fumarate (Ph.Eur.)Change notification08.12.2025OtherSeroquel Prolong 50 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification08.12.2025OtherSeroquel Prolong 300 mg prolonged-release tablets
    Quetiapine fumarate (Ph.Eur.)Change notification08.12.2025OtherSeroquel Prolong 200 mg prolonged-release tablets
  • 2025.12.08
    BfArMボトルネック・レポート（2025年12月1日～12月7日）

    供給不足データベースLieferengpass Datenbankenが一時的にダウンしているようです（12月8日）。

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