Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 February 2013

This page provides an overview of the opinions adopted at the February 2013 meeting of the CHMP and other important outcomes.

In the table below, readers can view the main opinions adopted at the meeting, as well as information on referral procedures.

The Agency publishes a new page following the CHMP meeting each month.

Name of medicine	Hexacima
Common name	diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Marketing-authorisation applicant	Sanofi Pasteur S.A.
Therapeutic indication	Primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type B (Hib).
More information	CHMP summary of positive opinion for Hexacima

Name of medicine	Hexyon
Common name	diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Marketing-authorisation applicant	Sanofi Pasteur MSD, SNC
Therapeutic indication	Primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type B (Hib).
More information	CHMP summary of positive opinion for Hexyon

Name of medicine	Pheburane
Common name	sodium phenylbutyrate
Marketing-authorisation applicant	Lucane Pharma
Therapeutic indication	Chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase. Indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). Also indicated in patients with late-onset disease (partial enzyme deficiencies, presenting after the first month of life) with a history of hyperammonaemic encephalopathy.
More information	CHMP summary of positive opinion for Pheburane

Name of medicine	Imatinib Actavis
International non-proprietary name (INN)	imatinib
Marketing-authorisation applicant	Actavis Group PTC ehf
Therapeutic indication	Treatment of Philadelphia-chromosome (bcr-abl)-positive (Ph+) chronic myeloid leukaemia (CML)
More information	CHMP summary of positive opinion for Imatinib Actavis

Name of medicine	Memantine LEK
INN	memantine
Marketing-authorisation applicant	Pharmathen S.A.
Therapeutic indication	Treatment of patients with moderate to severe Alzheimer's disease
More information	CHMP summary of positive opinion for Memantine LEK

Name of medicine	Memantine Mylan
INN	memantine hydrochloride
Marketing-authorisation applicant	Generics [UK] Ltd.
Therapeutic indication	Treatment of patients with moderate to severe Alzheimer's disease
More information	CHMP summary of positive opinion for Memantine Mylan

Name of medicine	Nemdatine
INN	memantine hydrochloride
Marketing-authorisation applicant	Actavis Group PTC ehf
Therapeutic indication	Treatment of patients with moderate to severe Alzheimer's disease
More information	CHMP summary of positive opinion for Nemdatine

Name of medicine	Qsiva
INN	phentermine / topiramate
Marketing-authorisation applicant	Vivus BV
Therapeutic indication	Treatment of obesity
More information	Questions and answers on the refusal of the marketing authorisation for Qsiva (phentermine / topiramate)

Name of medicine	Cervarix
Common name	human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, absorbed)
Marketing-authorisation holder	GlaxoSmithKline Biologicals
Change to a therapeutic indication (changes in bold)	Cervarix is a vaccine for use from the age of 9 years for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic human papillomavirus (HPV) types. See section 5.1 for important information on the data that support this indication.
More information	CHMP post-authorisation summary of positive opinion for Cervarix

Name of medicine	Privigen
INN	human normal immunoglobulin (Ivig)
Marketing-authorisation holder	CSL Behring GmbH
Therapeutic indication (changes in bold)	Replacement therapy in adults, and children and adolescents (0-18 years) in: primary immunodeficiency (PID) syndromes with impaired antibody production (see section 4.4); hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple-myeloma patients who have failed to respond to pneumococcal immunisation; hypogammaglobulinaemia in patients after allogeneic haematopoietic stem-cell transplantation (HSCT); congenital AIDS with recurrent bacterial infections. Immunomodulation in adults, and children and adolescents (0-18 years) in: primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count; Guillain-Barré syndrome; Kawasaki disease; chronic inflammatory demyelinating polyneuropathy (CIDP). Only limited experience is available of use of intravenous immunoglobulins in children with CIDP.
More information	CHMP post-authorisation summary of positive opinion for Privigen