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 Alecensa, Bydureon, Cubicin, Faslodex, Pegasys 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.