Envarsus (tacrolimus)
- Region
- 🇪🇺 EU
- Active substance
- tacrolimus
- Company
- Chiesi Farmaceutici S.p.A.
- Status
- Authorised
- Therapeutic area
- Graft Rejection
- CHMP opinion
- Thu 22 May 2014
- EU approval
- Fri 18 Jul 2014
- Application
- EMEA/H/C/002655
- ATC
- L04AD02
- Official record
- www.ema.europa.eu
Indication
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Advagraf Authorised · Astellas Pharma Europe BV
- 🇪🇺 Protopic Authorised · LEO Pharma A/S
- 🇪🇺 Tacforius Authorised · Teva B.V.
- 🇪🇺 Modigraf Authorised · Astellas Pharma Europe B.V.
- 🇪🇺 Protopy Withdrawn · Astellas Pharma GmbH
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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.