Graft Rejection

• EMA approval · 2026-07-03
  EMA Authorised: Advagraf (tacrolimus) — Astellas Pharma Europe BV

  Advagraf (tacrolimus) by Astellas Pharma Europe BV has been authorised for use in the EU for graft rejection indications.

• EMA approval · 2026-06-05
  EMA Authorised: CellCept (mycophenolate mofetil) — Roche Registration GmbH

  EMA has authorised CellCept (mycophenolate mofetil) under Roche Registration GmbH for use in graft rejection indications.

• EMA approval · 2026-06-04
  EMA Authorised: Rapamune (sirolimus) — Pfizer Europe MA EEIG

  European Medicines Agency authorises Rapamune (sirolimus) for graft rejection and kidney transplantation.

• EMA approval · 2026-04-23
  EMA Authorised: Jayempi (azathioprine) — Lipomed GmbH

  The EMA authorised Jayempi (azathioprine) by Lipomed GmbH for preventing graft rejection in organ transplant patients.

• EMA approval · 2026-04-23
  EMA Authorised: Nulojix (belatacept) — Bristol-Myers Squibb Pharma EEIG

  The EMA authorised belatacept (Nulojix) for use in kidney transplant recipients to prevent graft rejection; the decision date was 16 April 2…

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• EMA approval · 2026-04-10
  EMA Authorised: Myclausen (mycophenolate mofetil) — Passauer Pharma GmbH

  EMA authorised the drug Myclausen (mycophenolate mofetil) by Passauer Pharma GmbH. It is indicated for graft rejection in transplant patient…

• EMA approval · 2026-04-10
  EMA Authorised: Myfenax (mycophenolate mofetil) — Teva B.V.

  The European Medicines Agency authorised Myfenax, a generic mycophenolate mofetil product by Teva B.V., for preventing graft rejection.

• EMA approval · 2026-04-10
  EMA Authorised: CellCept (mycophenolate mofetil) — Roche Registration GmbH

  The European Medicines Agency authorized CellCept (mycophenolate mofetil) by Roche Registration GmbH for preventing graft rejection in trans…

• EMA approval · 2025-12-19
  EMA Authorised: Simulect (basiliximab) — Novartis Europharm Limited

  The EMA has authorised Simulect (basiliximab) for use in preventing graft rejection in kidney transplantation, with Novartis Europharm Limit…

• EMA approval · 2025-09-17
  EMA Authorised: Rapamune (sirolimus) — Pfizer Europe MA EEIG

  The EMA authorised Rapamune (sirolimus) for preventing graft rejection in kidney transplantation.

• EMA approval · 2025-03-03
  EMA Authorised: Modigraf (tacrolimus) — Astellas Pharma Europe B.V.

  The European Medicines Agency authorised Modigraf (tacrolimus) by Astellas Pharma Europe B.V. for preventing graft rejection in transplant p…

• EMA approval · 2025-02-28
  EMA Authorised: Envarsus (tacrolimus) — Chiesi Farmaceutici S.p.A.

  The EMA authorised Envarsus (tacrolimus) by Chiesi Farmaceutici S.p.A. for prevention of graft rejection in organ transplantation.

• FDA approval · 2021-09-23
  FDA Approved: MYCOPHENOLIC ACID — Original Application (Ascend Laboratories, LLC)

  FDA approved the original application for generic mycophenolic acid by Ascend Laboratories, authorizing its use to prevent organ transplant …

• FDA approval · 2021-08-11
  FDA Approved: MYCOPHENOLATE MOFETIL — Supplemental Application (CONCORD BIOTECH LIMITED)

  The FDA approved a supplemental application for mycophenolate mofetil from Concord Biotech Limited, resulting in approval of this generic im…