Amlodipine / Valsartan Mylan (amlodipine;valsartan)
Generic
- Region
- 🇪🇺 EU
- Active substance
- amlodipine;valsartan
- Company
- Mylan Pharmaceuticals Limited
- Status
- Authorised
- Therapeutic area
- Hypertension
- CHMP opinion
- Thu 28 Jan 2016
- EU approval
- Tue 22 Mar 2016
- Designations
- Generic
- Application
- EMEA/H/C/004037
- ATC
- C09DB01
- Official record
- www.ema.europa.eu
Indication
Treatment of essential hypertension. Amlodipine/Valsartan Mylan is indicated in adults whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.