BfArMボトルネック・レポート（2025年11月3日～11月9日）

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Active ingredients
Message type
Date of last messageType of reasonAM designation
Darifenacin hydrobromideInitial report07.11.2025OtherDarifenacin Aristo 15 mg prolonged-release tablets
Tolterodine tartrateInitial report07.11.2025OtherTolterodine Aristo 1 mg film-coated tablets
Tolterodine tartrateInitial report07.11.2025OtherTolterodine-Aristo 2 mg film-coated tablets
PosaconazoleChange notification07.11.2025OtherPosaconazole HEXAL 40 mg/ml oral suspension
Tolterodine tartrateInitial report07.11.2025OtherDetrusitol 1 mg film-coated tablets
Beclomethasone dipropionate (Ph.Eur.)Change notification07.11.2025OtherBeclorhinol aquosum 50 micrograms
Paliperidone palmitateChange notification06.11.2025OtherXEPLION 25 mg prolonged-release suspension for injection – OP1ml
Rifampicin sodiumChange notification06.11.2025OtherEremfat i.v. 600mg
NitrendipineInitial report06.11.2025OtherNitrendipine AL 10
UrapidilInitial report06.11.2025OtherUrapidil AL 90 mg hard capsules, delayed release
UrapidilInitial report06.11.2025OtherUrapidil AL 30 mg hard capsules, delayed release
ImiquimodChange notification06.11.2025Production problemAldara 5% cream – OP24
Calcium folinate hydrateChange notification06.11.2025Production problemCalcium folinate onkovis 10 mg/ml solution for injection
Quetiapine fumarate (Ph.Eur.)Change notification06.11.2025OtherQuetiapine AL 100 mg film-coated tablets
Salbutamol sulfateInitial report05.11.2025OtherBronchospray Autohaler
ImiquimodChange notification05.11.2025Production problemImikeraderm 50 mg/g cream
Sodium mycophenolateInitial report05.11.2025OtherMycophenolic acid HEXAL 180 mg gastro-resistant tablets
Sodium mycophenolateChange notification05.11.2025OtherMycophenolic acid HEXAL 360 mg gastro-resistant tablets
Sitagliptin hydrochloride monohydrateChange notification05.11.2025Production problemSitagliptin PUREN 50 mg film-coated tablets
NimodipineChange notification05.11.2025OtherNimodipine Hexal 30 mg
Propranolol hydrochlorideInitial report05.11.2025OtherPropra-ratiopharm 40 mg film-coated tablets
Propranolol hydrochlorideInitial report05.11.2025OtherPropra-ratiopharm 10 mg film-coated tablets
Dexamethasone dihydrogen phosphate disodium (Ph.Eur.)Initial report05.11.2025OtherDexa-ratiopharm 4 mg solution for injection
Ipratropium bromide (Ph.Eur.)Change notification05.11.2025Production problemIpratropium Teva 250 micrograms/1 ml solution for nebulizer
BuprenorphineChange notification05.11.2025OtherBuprenorphine AWD Matrix 52.5 micrograms/h Transdermal patch
BuprenorphineChange notification05.11.2025OtherBuprenorphine AWD Matrix 70 micrograms/h Transdermal patch
Methylphenidate hydrochlorideChange notification05.11.2025OtherMethylphenidate-ratiopharm 10 mg modified-release hard capsules
Galantamine hydrobromideChange notification05.11.2025OtherGalantamine-ratiopharm 8 mg hard capsules, delayed release
CarbamazepineChange notification05.11.2025OtherCarbamazepine-ratiopharm 200 mg prolonged-release tablets
BuprenorphineChange notification05.11.2025OtherBuprenorphine-ratiopharm 70 micrograms/h transdermal patch
BuprenorphineChange notification05.11.2025OtherBuprenorphine-ratiopharm 52.5 micrograms/h Transdermal patch
BuprenorphineChange notification05.11.2025OtherBuprenorphine-ratiopharm 35 micrograms/h transdermal patch
AlprazolamChange notification05.11.2025OtherAlprazolam-ratiopharm 1.0 mg tablets
Methylphenidate hydrochlorideChange notification05.11.2025OtherMethylphenidate-ratiopharm 40 mg modified-release hard capsules
Doxepine hydrochloride (Ph.Eur.)Change notification04.11.2025Production problemDoxepin 25 Holsten
Doxepine hydrochloride (Ph.Eur.)Change notification04.11.2025OtherDoxepin 50 Holsten
Doxepine hydrochloride (Ph.Eur.)Change notification04.11.2025Production problemDoxepin 75 Holsten
GabapentinChange notification04.11.2025OtherGabapentin Holsten 300 mg hard capsules
GabapentinChange notification04.11.2025Production problemGabapentin Holsten 600 mg film-coated tablets
GabapentinChange notification04.11.2025OtherGabapentin Holsten 800 mg film-coated tablets
MercaptopurineChange notification04.11.2025OtherMercaptopurine Holsten 50 mg tablets
LevetiracetamChange notification04.11.2025OtherLevetiracetam Holsten 250 mg film-coated tablets
Ipratropium bromide (Ph.Eur.); salbutamol sulfateChange notification04.11.2025Production problemCOMBIPRASAL 0.5 mg / 2.5 mg solution for nebulizer
Ipratropium bromideChange notification04.11.2025Production problemIpratropium bromide 250 micrograms / 1 ml Stulln
LevetiracetamInitial report04.11.2025OtherLevetiracetam Holsten 750 mg film-coated tablets
Amlodipine besylate; hydrochlorothiazide; valsartanInitial report04.11.2025OtherAmlodipine/Valsartan/HCT Holsten 5 mg/160 mg/12.5 mg film-coated tablets
DocetaxelInitial report04.11.2025Production problemDocetaxel Aurobindo 20 mg/ml concentrate for solution for infusion
Venlafaxine hydrochlorideInitial report04.11.2025OtherVenlafaxine Aurobindo 75 mg hard capsule, delayed release
TopiramateInitial report04.11.2025OtherTopiramate PUREN 50 mg film-coated tablets
Tranexamic acidInitial report04.11.2025Production problemTranexamic acid PUREN 100 mg/ml solution for injection
Duloxetine hydrochlorideInitial report04.11.2025OtherDuloxetine PUREN 60 mg gastro-resistant hard capsules
AnastrozoleInitial report04.11.2025Production problemAnastroPUREN 1 mg film-coated tablets
Duloxetine hydrochlorideInitial report04.11.2025OtherDuloxetine PUREN 30 mg gastro-resistant hard capsules
Quetiapine fumarate (Ph.Eur.)Change notification04.11.2025OtherSeroquel Prolong 200 mg prolonged-release tablets
Insulin lisproInitial report04.11.2025OtherHumalog KwikPen 100 E/ml solution for injection – OP (5x3ml)
OlanzapineChange notification04.11.2025Production problemZYPREXA
Ipratropium bromide (Ph.Eur.); salbutamol sulfateInitial report04.11.2025OtherIpratropium/salbutamol Cipla 0.5 mg/2.5 mg solution for nebulizer
Cefazolin sodiumInitial report04.11.2025Production problemCefazolin Hikma 2 g powder for solution for injection/infusion
Amiodarone hydrochlorideInitial report04.11.2025OtherAmiodarone PUREN 200 mg tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Initial report04.11.2025OtherAtorvastatin PUREN 80 mg film-coated tablets
Atorvastatin calcium trihydrate (Ph.Eur.)Change notification04.11.2025OtherAtorvastatin PUREN 20 mg film-coated tablets
Methylphenidate hydrochlorideChange notification04.11.2025OtherMethylphenidate hydrochloride HEXAL 36 mg prolonged-release tablets
Atomoxetine hydrochlorideChange notification04.11.2025OtherAtomoxe – 1 A Pharma 100 mg hard capsules
TopiramateChange notification04.11.2025Production problemTopiramate PUREN 100 mg film-coated tablets
Atomoxetine hydrochlorideChange notification04.11.2025OtherAtomoxe – 1 A Pharma 18 mg hard capsules
Atomoxetine hydrochlorideChange notification04.11.2025OtherAtomoxe – 1 A Pharma 25 mg hard capsules
Atomoxetine hydrochlorideChange notification04.11.2025OtherAtomoxe – 1 A Pharma 40 mg hard capsules
Quetiapine fumarate (Ph.Eur.)Change notification04.11.2025OtherSeroquel Prolong 400 mg prolonged-release tablets
Atomoxetine hydrochlorideChange notification04.11.2025OtherAtomoxe – 1 A Pharma 60 mg hard capsules
Atomoxetine hydrochlorideChange notification04.11.2025OtherAtomoxe – 1 A Pharma 80 mg hard capsules
UrapidilChange notification04.11.2025Production problemUrapidil Bluefish 30 mg hard capsules, delayed release
UrapidilChange notification04.11.2025Production problemUrapidil Bluefish 90 mg hard capsules, delayed release
Quetiapine fumarate (Ph.Eur.)Initial report04.11.2025OtherSeroquel Prolong 150 mg prolonged-release tablets
AprepitantInitial report03.11.2025Production problemAprepitant Zentiva 80 mg hard capsules
AprepitantInitial report03.11.2025Production problemAprepitant Zentiva 125 mg hard capsules
AprepitantChange notification03.11.2025Production problemAprepitant Zentiva 80 mg and 125 mg hard capsules
DimenhydrinateInitial report03.11.2025Production problemDimenhydrinate PANPHARMA 6.2 mg/ml solution for injection (i.v.)
ZonisamideInitial report03.11.2025Production problemZonisamide Glenmark 100 mg hard capsules
AnastrozoleChange notification03.11.2025OtherAnastrozole Denk 1 mg film-coated tablets
Perindopril tert-butylamineInitial report03.11.2025OtherPerindopril Erbumine Glenmark 4 mg tablets
RiluzoleInitial report03.11.2025OtherGlentek 50 mg film-coated tablets
Iron(III) sodium D-gluconate hydroxide oxide complex (approx. 2:1:1:x:y)Change notification03.11.2025OtherFerrlecit 62.5 mg
Clonidine hydrochlorideChange notification03.11.2025OtherClonidine-ratiopharm 75
Rizatriptan benzoateChange notification03.11.2025Production problemRizatriptan Glenmark 5 mg tablets
Clonidine hydrochlorideChange notification03.11.2025OtherClonidine-ratiopharm 150
Rizatriptan benzoateChange notification03.11.2025Production problemRizatriptan Glenmark 5 mg orodispersible tablets
Clonidine hydrochlorideChange notification03.11.2025OtherClonidine-ratiopharm 300
Rizatriptan benzoateChange notification03.11.2025Production problemRizatriptan Glenmark 10 mg orodispersible tablets
Rizatriptan benzoateChange notification03.11.2025Production problemRizatriptan Glenmark 10 mg tablets
Quetiapine fumarate (Ph.Eur.)Change notification03.11.2025Production problemQuetiapine Glenmark 200 mg prolonged-release tablets
Fusidic acid (Ph.Eur.)Change notification03.11.2025Production problemFucithalmic 10 mg/g eye drops
Dexketoprofen trometamolChange notification03.11.2025Production problemSympal inject 50 mg solution for injection/infusion
Hydrocortisone acetate (Ph.Eur.)Change notification03.11.2025Production problemHydrocortisone-POS N 2.5%
Dexamethasone dihydrogen phosphate disodium (Ph.Eur.); gentamicin sulfateChange notification03.11.2025Production problemDexa-Gentamicin
Prednisolone acetateChange notification03.11.2025Production problemPredni-POS 1%
AciclovirChange notification03.11.2025Production problemVirupos
FluorometholoneChange notification03.11.2025Production problemFluoropos
Gentamicin sulfateChange notification03.11.2025Production problemGentamicin-POS
Phenylephrine hydrochlorideChange notification03.11.2025Production problemNeosynephrine-POS 5%
2025年11月10日
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