Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 October 2017

News 13/10/2017

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.

For more information on this negative opinion, please see the questions-and-answers document in the grid below.

Agenda and minutes

The agenda of the October 2017 meeting is published on EMA's website. Minutes of the September 2017 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the October 2017 CHMP meeting are presented in the graphic below.

More information on all other outcomes of the CHMP October 2017 meeting is available in the grid below.

 October 2017

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Positive recommendation on new generic medicine

Name of medicineTacforius
INNtacrolimus
Marketing-authorisation applicantTeva B.V.
Therapeutic indicationProphylaxis and treatment of transplant rejection
More information PDF iconSummary of opinion for Tacforius

Positive recommendations on extensions of therapeutic indications

Name of medicineAlecensa
INNalectinib
Marketing-authorisation holderRoche Registration Limited
More information PDF iconSummary of opinion for Alecensa

Name of medicineBydureon
INNexenatide
Marketing-authorisation holderAstraZeneca AB
More information PDF iconSummary of opinion for Bydureon

Name of medicineCubicin
INNdaptomycin
Marketing-authorisation holderMerck Sharp & Dohme Limited
More information PDF iconSummary of opinion for Cubicin

Name of medicineFaslodex
INNfulvestrant
Marketing-authorisation holderAstraZeneca UK Ltd
More information PDF iconSummary of opinion for Faslodex

Name of medicine Pegasys
INNpeginterferon alfa-2a
Marketing-authorisation holderRoche Registration Limited
More information PDF iconSummary of opinion for Pegasys

Name of medicineZytiga
INNabiraterone acetate
Marketing-authorisation holderJanssen-Cilag International NV
More information PDF iconSummary of opinion for Zytiga

Re-examination of recommendation for extension of indication

Name of medicineRaxone
INNidebenone
Marketing-authorisation holderSanthera Pharmaceuticals (Deutschland) GmbH
More information PDF iconQuestions and answers on Raxone

Outcome of re-examination of arbitration procedure

Name of medicineAlcover 750 mg, 1250 mg, 1750 mg granules
INNsodium oxybate
Marketing-authorisation holderD&A Pharma
More informationQuestions and answers on Alcover 750 mg, 1250 mg, 1750 mg granules

Other updates

PDF iconOverview of (invented) names reviewed in September 2017 by the Name Review Group (NRG)
PDF iconScientific advice and protocol assistance
PDF iconRecommendations on eligibility to PRIME scheme

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