Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 October 2017
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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.
Positive recommendation on new generic medicine
| Name of medicine | Tacforius |
|---|---|
| INN | tacrolimus |
| Marketing-authorisation applicant | Teva B.V. |
| Therapeutic indication | Prophylaxis and treatment of transplant rejection |
| More information | CHMP summary of positive opinion for Tacforius |
Positive recommendations on extensions of therapeutic indications
| Name of medicine | Alecensa |
|---|---|
| INN | alectinib |
| Marketing-authorisation holder | Roche Registration Limited |
| More information | CHMP post-authorisation summary of positive opinion for Alecensa |
| Name of medicine | Bydureon |
|---|---|
| INN | exenatide |
| Marketing-authorisation holder | AstraZeneca AB |
| More information | CHMP post-authorisation summary of positive opinion for Bydureon |
| Name of medicine | Cubicin |
|---|---|
| INN | daptomycin |
| Marketing-authorisation holder | Merck Sharp & Dohme Limited |
| More information | CHMP post-authorisation summary of positive opinion for Cubicin (II-61) |
| Name of medicine | Faslodex |
|---|---|
| INN | fulvestrant |
| Marketing-authorisation holder | AstraZeneca UK Ltd |
| More information | CHMP post-authorisation summary of positive opinion for Faslodex |
| Name of medicine | Pegasys |
|---|---|
| INN | peginterferon alfa-2a |
| Marketing-authorisation holder | Roche Registration Limited |
| More information | CHMP post-authorisation summary of positive opinion for Pegasys (II-91) |
| Name of medicine | Zytiga |
|---|---|
| INN | abiraterone acetate |
| Marketing-authorisation holder | Janssen-Cilag International NV |
| More information | CHMP post-authorisation summary of positive opinion for Zytiga |
Re-examination of recommendation for extension of indication
| Name of medicine | Raxone |
|---|---|
| INN | idebenone |
| Marketing-authorisation holder | Santhera Pharmaceuticals (Deutschland) GmbH |
| More information | Questions and answers on the refusal of a change to the marketing authorisation for Raxone (idebenone) |
Outcome of re-examination of arbitration procedure
| Name of medicine | Alcover 750 mg, 1250 mg, 1750 mg granules |
|---|---|
| INN | sodium oxybate |
| Marketing-authorisation holder | D&A Pharma |
| More information | Questions and answers on Alcover 750 mg, 1250 mg, 1750 mg granules |
Other updates