Modigraf (tacrolimus)
- Region
- 🇪🇺 EU
- Active substance
- tacrolimus
- Company
- Astellas Pharma Europe B.V.
- Status
- Authorised
- Therapeutic area
- Graft Rejection
- EU approval
- Fri 15 May 2009
- Application
- EMEA/H/C/000954
- ATC
- L04AD02
- Official record
- www.ema.europa.eu
Indication
Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric 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.
- 🇪🇺 Envarsus Authorised · Chiesi Farmaceutici S.p.A.
- 🇪🇺 Protopy Withdrawn · Astellas Pharma GmbH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.