One generic medicine recommended for approval

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended one generic medicine for approval at its October meeting: Tacforius (tacrolimus), for prophylaxis and treatment of transplant rejection.

Six recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for AlecensaBydureonCubicinFaslodexPegasys and Zytiga.

Request for re-examination of a CHMP recommendation

The applicant for Raxone (idebenone) has requested a re-examination of the Committee’s negative opinion for this medicine adopted at the September 2017 meeting. The CHMP will now re-examine this opinion and issue a final recommendation.

Posted on the EMA website on 13 October 2017