Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 September 2011

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23/09/2011

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 September 2011

This page lists the opinions adopted at the September 2011 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

The new format allows users to view the main opinions adopted at the meeting, along with information on referral procedures, in a clear tabular format. Users can click on the links within the page to read individual press releases and more detailed information about the opinions.

The new format replaces the two PDF documents that used to list each meeting's outcome: the CHMP meeting highlights, published on the Friday following the meeting and the CHMP monthly report, published around a week later. The Agency will publish a new page following each month's CHMP meeting.

The Agency is gathering feedback from journalists and other stakeholders over the first three months of publication. It will make any necessary changes to the format in early 2012.

Positive opinions for new medicines

Name of medicineINNMarketing authorisation applicant

Dificlir

 

Press release: European Medicines Agency recommends authorisation of novel antibiotic agent

fidaxomicinFGK Representative Service GmbH
Edarbiazilsartan medoxomilTakeda Global Research and Development Centre (Europe) Ltd
Iprezivazilsartan medoxomilTakeda Global Research and Development Centre (Europe) Ltd
Komboglyzesaxagliptin / metforminBristol-Myers Squibb / AstraZeneca EEIG
Onduarptelmisartan / amlodipineBoehringer Ingelheim International GmbH
Rasitrioaliskiren / amlodipine / hydrochlorothiazideNovartis Europharm Ltd
EdurantrilpivirineJanssen-Cilag International N.V.
Evipleraemtricitabine / rilpivirine / tenofovir disoproxilGilead Sciences International Ltd


Positive opinions for generics

Name of medicineINNMarketing authorisation applicant
DasseltadesloratadineKrka, d.d., Novo mesto
Desloratadine KrkadesloratadineKrka, d.d., Novo mesto
Desloratadine TevadesloratadineTeva Pharma B.V.
Levetiracetam Actavis GrouplevetiracetamActavis Group PTC ehf
Pioglitazone ActavispioglitazoneActavis Group PTC ehf
Pioglitazone Actavis GrouppioglitazoneActavis Group PTC ehf
Pioglitazone TevapioglitazoneTeva Pharma B.V.
Pioglitazone Teva PharmapioglitazoneTeva Pharma B.V.
Pioglitazone Teva GenericspioglitazoneTeva Generics B.V.
SepioglinpioglitazoneVaia S.A.


Positive opinions for extensions of therapeutic indications

Name of medicineINNMarketing authorisation holder
AlimtapemetrexedEli Lilly Nederland B.V.
AvastinbevacizumabRoche Registration Ltd
Levemir (II-48 & II-51)insulin detemirNovo Nordisk A/S
Prevenar 13pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)Wyeth Lederle Vaccines S.A.
SoliriseculizumabAlexion Europe SAS
XareltorivaroxabanBayer Schering Pharma AG


Final opinions on other variations

Name of medicineINNMarketing authorisation holder
VictozaliraglutideNovo Nordisk A/S


Final opinions on safety reviews for centrally authorised medicines

Name of medicineINNMarketing authorisation holder
MultaqdronedaroneSanofi-aventis
RevlimidlenalidomideCelgene Europe Ltd
Vimpat syrup 15 mg/mllacosamideUCB Pharma SA


Final opinions on safety reviews for non-centrally authorised medicines

Name of medicineINNMarketing authorisation holder
Dialysis solutions produced at Castlebar Baxter group of companies and associated companies
Suppositories containing terpenic derivativescamphor, cincole, pine / essential oil of pine needle, essential oil of eucalyptus, terpine, niaouli, essential oil of turpentine, terpineol, wild thyme 


Product shortages

Name of medicineINNMarketing authorisation holder
Apidrainsulin glulisineSanofi-aventis Deutschland GmbH


Other press releases


Other updates

Opinions on annual re-assessments and renewals

Opinions on safety variations

Medicines granted a Community marketing authorisation under the centralised procedure since the July 2011 CHMP meeting

Overview of designated orphan medicines that have been the subject of a centralised application for marketing authorisation

Scientific advice and protocol assistance

Guidelines and concept papers adopted during the September 2011 CHMP meeting

Organisational matters

Procedural announcements

Related information

Contact point:

Monika Benstetter or Sabine Haubenreisser
Tel. +44 (0)20 7418 8427
E-mail: press@ema.europa.eu