Adcirca (previously Tadalafil Lilly) (tadalafil)
- Region
- 🇪🇺 EU
- Active substance
- tadalafil
- Company
- Eli Lilly Nederland B.V.
- Status
- Authorised
- Therapeutic area
- Hypertension, Pulmonary
- CHMP opinion
- Thu 24 Jul 2008
- EU approval
- Wed 01 Oct 2008
- Application
- EMEA/H/C/001021
- ATC
- G04BE08
- Official record
- www.ema.europa.eu
Indication
AdultsTreatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease. Paediatric populationTreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III.
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
- 🇪🇺 Talmanco (previously Tadalafil Generics) Authorised · Viatris Limited
- 🇪🇺 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.