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

Positive opinions for generics

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

Positive opinions for extensions of therapeutic indications

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

Final opinions on other variations

Name of medicine	INN	Marketing authorisation holder
Questions and answers on the outcome of extension of indication application for Victoza (liraglutide)	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