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

News 23/09/2011

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

PDF iconDificlir

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

fidaxomicinFGK Representative Service GmbH
PDF iconEdarbi azilsartan medoxomilTakeda Global Research and Development Centre (Europe) Ltd
PDF iconIpreziv azilsartan medoxomilTakeda Global Research and Development Centre (Europe) Ltd
PDF iconKomboglyze saxagliptin / metforminBristol-Myers Squibb / AstraZeneca EEIG
PDF iconOnduarp telmisartan / amlodipineBoehringer Ingelheim International GmbH
PDF iconRasitrio aliskiren / amlodipine / hydrochlorothiazideNovartis Europharm Ltd
PDF iconEdurant rilpivirineJanssen-Cilag International N.V.
PDF iconEviplera emtricitabine / rilpivirine / tenofovir disoproxilGilead Sciences International Ltd


Positive opinions for generics

Name of medicineINNMarketing authorisation applicant
PDF iconDasselta desloratadineKrka, d.d., Novo mesto
PDF iconDesloratadine Krka desloratadineKrka, d.d., Novo mesto
PDF iconDesloratadine Teva desloratadineTeva Pharma B.V.
PDF iconLevetiracetam Actavis Group levetiracetamActavis Group PTC ehf
PDF iconPioglitazone Actavis pioglitazoneActavis Group PTC ehf
PDF iconPioglitazone Actavis Group pioglitazoneActavis Group PTC ehf
PDF iconPioglitazone Teva pioglitazoneTeva Pharma B.V.
PDF iconPioglitazone Teva Pharma pioglitazoneTeva Pharma B.V.
PDF iconPioglitazone Teva Generics pioglitazoneTeva Generics B.V.
PDF iconSepioglin pioglitazoneVaia S.A.


Positive opinions for extensions of therapeutic indications

Name of medicineINNMarketing authorisation holder
PDF iconAlimta pemetrexedEli Lilly Nederland B.V.
PDF iconAvastin bevacizumabRoche Registration Ltd
PDF iconLevemir (II-48 & II-51)insulin detemirNovo Nordisk A/S
PDF iconPrevenar 13 pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)Wyeth Lederle Vaccines S.A.
PDF iconSoliris eculizumabAlexion Europe SAS
PDF iconXarelto rivaroxabanBayer Schering Pharma AG


Final opinions on other variations

Name of medicineINNMarketing authorisation holder
PDF iconVictoza liraglutideNovo 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
PDF iconApidra insulin glulisineSanofi-aventis Deutschland GmbH


Other press releases


Other updates

PDF iconOpinions on annual re-assessments and renewals

PDF iconOpinions on safety variations

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

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

PDF iconScientific advice and protocol assistance

PDF iconGuidelines and concept papers adopted during the September 2011 CHMP meeting

PDF iconOrganisational matters

PDF iconProcedural announcements

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