Tacforius (tacrolimus)
Generic
- Region
- 🇪🇺 EU
- Active substance
- tacrolimus
- Company
- Teva B.V.
- Status
- Authorised
- Therapeutic area
- Liver Transplantation; Kidney Transplantation
- CHMP opinion
- Thu 12 Oct 2017
- EU approval
- Fri 08 Dec 2017
- Designations
- Generic
- Application
- EMEA/H/C/004435
- 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
- 🇪🇺 Envarsus Authorised · Chiesi Farmaceutici S.p.A.
- 🇪🇺 Modigraf Authorised · Astellas Pharma Europe B.V.
- 🇪🇺 Protopy Withdrawn · Astellas Pharma GmbH
Follow Tacforius
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.