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 medicine	INN	Marketing authorisation applicant
Dificlir Press release: European Medicines Agency recommends authorisation of novel antibiotic agent	fidaxomicin	FGK Representative Service GmbH
Edarbi	azilsartan medoxomil	Takeda Global Research and Development Centre (Europe) Ltd
Ipreziv	azilsartan medoxomil	Takeda Global Research and Development Centre (Europe) Ltd
Komboglyze	saxagliptin / metformin	Bristol-Myers Squibb / AstraZeneca EEIG
Onduarp	telmisartan / amlodipine	Boehringer Ingelheim International GmbH
Rasitrio	aliskiren / amlodipine / hydrochlorothiazide	Novartis Europharm Ltd
Edurant	rilpivirine	Janssen-Cilag International N.V.
Eviplera	emtricitabine / rilpivirine / tenofovir disoproxil	Gilead Sciences International Ltd

Positive opinions for generics

Name of medicine	INN	Marketing authorisation applicant
Dasselta	desloratadine	Krka, d.d., Novo mesto
Desloratadine Krka	desloratadine	Krka, d.d., Novo mesto
Desloratadine Teva	desloratadine	Teva Pharma B.V.
Levetiracetam Actavis Group	levetiracetam	Actavis Group PTC ehf
Pioglitazone Actavis	pioglitazone	Actavis Group PTC ehf
Pioglitazone Actavis Group	pioglitazone	Actavis Group PTC ehf
Pioglitazone Teva	pioglitazone	Teva Pharma B.V.
Pioglitazone Teva Pharma	pioglitazone	Teva Pharma B.V.
Pioglitazone Teva Generics	pioglitazone	Teva Generics B.V.
Sepioglin	pioglitazone	Vaia S.A.

Positive opinions for extensions of therapeutic indications

Name of medicine	INN	Marketing authorisation holder
Alimta	pemetrexed	Eli Lilly Nederland B.V.
Avastin	bevacizumab	Roche Registration Ltd
Levemir (II-48 & II-51)	insulin detemir	Novo Nordisk A/S
Prevenar 13	pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)	Wyeth Lederle Vaccines S.A.
Soliris	eculizumab	Alexion Europe SAS
Xarelto	rivaroxaban	Bayer Schering Pharma AG

Final opinions on other variations

Name of medicine	INN	Marketing authorisation holder
Victoza	liraglutide	Novo Nordisk A/S

Final opinions on safety reviews for centrally authorised medicines

Name of medicine	INN	Marketing authorisation holder
Multaq	dronedarone	Sanofi-aventis
Revlimid	lenalidomide	Celgene Europe Ltd
Vimpat syrup 15 mg/ml	lacosamide	UCB Pharma SA

Final opinions on safety reviews for non-centrally authorised medicines

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