Talmanco (previously Tadalafil Generics) (tadalafil)
Generic
- Region
- 🇪🇺 EU
- Active substance
- tadalafil
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- Hypertension, Pulmonary
- CHMP opinion
- Thu 10 Nov 2016
- EU approval
- Mon 09 Jan 2017
- Designations
- Generic
- Application
- EMEA/H/C/004297
- ATC
- G04BE08
- Official record
- www.ema.europa.eu
Indication
Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Tadalafil Mylan Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Yuvanci Authorised · Janssen-Cilag International NV
- 🇪🇺 Adcirca (previously Tadalafil Lilly) Authorised · Eli Lilly Nederland B.V.
- 🇪🇺 Tadalafil Lilly Authorised · Eli Lilly Nederland B.V.
- 🇪🇺 Cialis Authorised · Eli Lilly Nederland 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.