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.

Positive recommendations on new medicines

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 Summary of 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 Summary of opinion for Hexyon

  

Positive recommendations on new hybrid medicines

Name of medicine Pheburane
Common name sodium phenylbutyrate
Marketing-authorisation applicant Lucane Pharma
Therapeutic indication Treatment of chronic management of urea-cycle disorders
More information Summary of opinion for Pheburane

  

Positive recommendations on new generic medicines

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 Summary of opinion for Imatinib Actavis

 

Name of medicine Memantine Mylan
INN memantine hydrochloride
Marketing-authorisation applicant Generics
[UK] Ltd.
Therapeutic indication Treatment of Alzheimer’s disease
More information Summary of opinion for Memantine Mylan

 

Name of medicine Nemdatine
INN memantine hydrochloride
Marketing-authorisation applicant Actavis Group PTC ehf
Therapeutic indication Treatment of Alzheimer’s disease
More information Summary of opinion for Nemdatine

  

Re-examination of recommendation for new medicine

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

  

Positive recommendations on extensions of therapeutic indications

Name of medicine Cervarix
Common name human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, absored)
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 Summary of 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 Summary of opinion for Privigen

Outcome of arbitration procedure

Name of medicine Furosemide Vitabalans 40 mg tablets
INN furosemide
Marketing-authorisation holder Vitabalans Oy
More information

Withdrawal of application

Name of medicine Ruvise
INN imatinib mesilate
More information

Other updates

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
Opinions on safety variations
Start of Community reviews
Scientific advice and protocol assistance
Guidelines and concept papers adopted
Overview of invented names reviewed in January 2013 by the Name Review Group (NRG)
Organisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

 

Posted on the EMA website on 22 February 2013