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drugs scandal
Following the drug scandal in Japan, the Federal Institute for Drugs and Medical Devices (BfArM) is also responding in Bonn. As of now, 80 copycat drugs, so-called generics, can no longer be sold . The reason: Inadequate study results.
The Federal Institute for Drugs and Medical Devices has investigated 176 medicines due to a drug scandal in Japan and immediately withdrew 80 of them from the market. The drugs had been subjected to manipulated bioequivalence studies . Bioequivalence studies are needed to verify the safety and correct composition of generic medicines. The verdict of the test: poor.
The drugs involved are antihypertensive agents, migraine, depression and heart attack prevention. If you take one of these 80 medicines, you should not react by yourself, but talk to your doctor or pharmacist. "These are medicines in different dosage forms and pack sizes, but each need their own approval, " said a spokesman for the BfArM. There are no indications of health risks for patients, it goes on to say.
The company is now discontinuing all studies. All disputes must be cleared out first, according to a spokesperson for GVK Biosciences.
The following drugs are affected by the study
Status: 09.12.2014145 / 1 of 80 AMIS: Medicines (AM29) © BfArM, BVL, PEI
Candesartan hydrochlorothiazide Liconsa 16 mg / 12.5 mg tablets
Candesartan hydrochlorothiazide Liconsa 32 mg / 12.5 mg tablets
Candesartan hydrochlorothiazide Liconsa 32 mg / 25 mg tablets
Candesartan hydrochlorothiazide Liconsa 8 mg / 12.5 mg tablets
Candesartan / HCT Heumann 16 mg / 12.5 mg tablets
Candesartan / HCT Heumann 32 mg / 12.5 mg tablets
Candesartan / HCT Heumann 32 mg / 25 mg tablets
Candesartan / HCT Heumann 8 mg / 12.5 mg tablets
Cefpodoxime Hormosan 200 mg film-coated tablets
Clopidogrel 75 mg film-coated tablets
Clopidogrel Dexcel 75 mg film-coated tablets
Entaburg 200 mg film-coated tablets
Entacapone AET 200 mg film-coated tablets
Entacapone STADA 200 mg film-coated tablets
Escitalopram Micro Labs 10 mg film-coated tablets
Escitalopram Micro Labs 15 mg film-coated tablets
Escitalopram Micro Labs 20 mg film-coated tablets
Escitalopram Micro Labs 5 mg film-coated tablets
Esomeprazole Mylan 20 mg enteric-coated tablets
Esomeprazole Mylan 40 mg enteric-coated tablets
Irbesartan Fair-Med 150 mg film-coated tablets
Irbesartan Fair-Med 300 mg film-coated tablets
Irbesartan Fair-Med 75 mg film-coated tablets
Irbesartan HCTZ Fair-Med 150 + 12.5 mg film-coated tablets
Irbesartan HCTZ Fair-Med 300 + 12.5 mg film-coated tablets
Irbesartan HCTZ Fair-Med 300 + 25 mg film-coated tablets
Irbesartan Heumann 150 mg film-coated tablets
Irbesartan Heumann 300 mg film-coated tablets
Irbesartan Heumann 75 mg film-coated tablets
Irbesartan Unichem 150mg film-coated tablets
Irbesartan Unichem 300mg film-coated tablets
Irbesartan Welding 150 mg film-coated tablets
Irbesartan Welding 300 mg film-coated tablets
Irbesartan Welding 75 mg film-coated tablets
Irbesartan / Hydrochlorothiazide Heumann 150 mg / 12.5 mg film-coated tablets
Irbesartan / Hydrochlorothiazide Heumann 300 mg / 12.5 mg film-coated tablets
Irbesartan / Hydrochlorothiazide Heumann 300 mg / 25 mg film-coated tablets
Irbesartan / Hydrochlorothiazide Welding 150 mg / 12.5 mg film-coated tablets
Irbesartan / Hydrochlorothiazide Welding 300 mg / 12.5 mg film-coated tablets
Irbesartan / Hydrochlorothiazide Welding 300 mg / 25 mg film-coated tablets
Levetiracetam beta 1000 mg film-coated tablets
Levetiracetam beta 250 mg film-coated tablets
Levetiracetam beta 500 mg film-coated tablets
Levetiracetam beta 750 mg film-coated tablets
Levetiracetam-Hormosan 1000 mg film-coated tablets
Levetiracetam-Hormosan 250 mg film-coated tablets
Levetiracetam-Hormosan 500 mg film-coated tablets
Levetiracetam-Hormosan 750 mg film-coated tablets
Losartan potassium beta 100 mg film-coated tablets
Losartan potassium beta 25 mg film-coated tablets
Losartan potassium beta 50 mg film-coated tablets
Losartan potassium beta 50 mg film-coated tablets
Losartan potassium beta 75 mg film-coated tablets
Pramipexole beta 0.088 mg tablets
Pramipexole beta 0.18 mg tablets
Pramipexole beta 0.35 mg tablets
Pramipexole beta 0.7 mg tablets
Repaglinide Mylan 0.5 mg tablets
Repaglinide Mylan 1 mg tablets
Repaglinide Mylan 2 mg tablets
Rizatriptan Mylan dura 10 mg orodispersible tablets
Rizatriptan Mylan Dura 5 mg orodispersible tablets
Tacpan 0.5 mg hard capsules
Tacpan 1 mg hard capsules
Tacpan 5 mg hard capsules
Valsartan beta 160 mg film-coated tablets
Valsartan beta 320 mg film-coated tablets
Valsartan beta 40 mg film-coated tablets
Valsartan beta 80 mg film-coated tablets
Valsartan / HCTZ Fair-Med Healthcare 160 mg / 12.5 mg film-coated tablets
Valsartan / HCTZ Fair-Med Healthcare 160 mg / 25 mg film-coated tablets
Valsartan / HCTZ Fair-Med Healthcare 320 mg / 12.5 mg film-coated tablets
Valsartan / HCTZ Fair-Med Healthcare 320 mg / 25 mg film-coated tablets
Valsartan / HCTZ Fair-Med Healthcare 80 mg / 12.5 mg film-coated tablets
VENLAFAXIN BASICS 150 mg hard capsules, retarded
VENLAFAXIN BASICS 37.5 mg hard capsules, retarded
VENLAFAXIN BASICS 75 mg hard capsules, retarded
Venlafaxine Heumann 150 mg hard capsules, retarded
Venlafaxine Heumann 37.5 mg hard capsules, retarded
Venlafaxine Heumann 75 mg hard capsules, retarded
