Rapamune (sirolimus)
- Region
- 🇪🇺 EU
- Active substance
- sirolimus
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Graft Rejection; Kidney Transplantation
- CHMP opinion
- Thu 16 Nov 2000
- EU approval
- Tue 13 Mar 2001
- Application
- EMEA/H/C/000273
- ATC
- L04AH01
- Official record
- www.ema.europa.eu
Indication
Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued. Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Hyftor Authorised · Plusultra pharma GmbH
- 🇪🇺 Torisel Authorised · Pfizer Europe MA EEIG
- 🇪🇺 Opsiria Application withdrawn · Santen Oy
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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.