Tolura (telmisartan)
Generic
- Region
- 🇪🇺 EU
- Active substance
- telmisartan
- Company
- KRKA tovarna zdravil d.d. Novo mesto
- Status
- Authorised
- Therapeutic area
- Hypertension
- CHMP opinion
- Thu 18 Mar 2010
- EU approval
- Fri 04 Jun 2010
- Designations
- Generic
- Application
- EMEA/H/C/001196
- ATC
- C09CA07
- Official record
- www.ema.europa.eu
Indication
Hypertension Treatment of essential hypertension in adults. Cardiovascular prevention Reduction of cardiovascular morbidity in patients with: manifest atherothrombotic cardiovascular disease (history of coronary heart disease or peripheral arterial disease) or; type 2 diabetes mellitus with documented target organ damage.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Micardis Authorised · Boehringer Ingelheim International GmbH
- 🇪🇺 Pritor Withdrawn · Bayer AG
- 🇪🇺 Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG) Withdrawn · Bayer AG
- 🇪🇺 PritorPlus Withdrawn · Bayer AG
- 🇪🇺 Kinzalkomb Withdrawn · Bayer AG
- 🇪🇺 Tolucombi Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Telmisartan Actavis Authorised · Actavis Group PTC ehf
- 🇪🇺 MicardisPlus Authorised · Boehringer Ingelheim International GmbH
- 🇪🇺 Actelsar HCT Authorised · Actavis Group PTC ehf
- 🇪🇺 Twynsta Authorised · Boehringer Ingelheim International GmbH
- 🇪🇺 Telmisartan Teva Pharma Authorised · Teva B.V.
- 🇪🇺 Telmisartan Teva Withdrawn · Teva B.V.
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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.