Tadalafil Mylan (tadalafil)
Generic
- Region
- 🇪🇺 EU
- Active substance
- tadalafil
- Company
- Mylan Pharmaceuticals Limited
- Status
- Authorised
- Therapeutic area
- Erectile Dysfunction
- EU approval
- Fri 21 Nov 2014
- Designations
- Generic
- Application
- EMEA/H/C/003787
- ATC
- G04BE08
- Official record
- www.ema.europa.eu
Indication
Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective, sexual stimulation is required. Tadalafil Mylan is not indicated for use by women.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Yuvanci Authorised · Janssen-Cilag International NV
- 🇪🇺 Talmanco (previously Tadalafil Generics) Authorised · Viatris Limited
- 🇪🇺 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.