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

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22/02/2013

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.


Positive recommendations on new medicines

Name of medicineHexacima
Common namediphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Marketing-authorisation applicantSanofi Pasteur S.A.
Therapeutic indicationPrimary 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 informationSummary of opinion for Hexacima

 

Name of medicineHexyon
Common namediphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Marketing-authorisation applicantSanofi Pasteur MSD, SNC
Therapeutic indicationPrimary 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 informationSummary of opinion for Hexyon

  

Positive recommendations on new hybrid medicines

Name of medicinePheburane
Common namesodium phenylbutyrate
Marketing-authorisation applicantLucane Pharma
Therapeutic indicationChronic 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 informationSummary of opinion for Pheburane

  

Positive recommendations on new generic medicines

Name of medicineImatinib Actavis
International non-proprietary name (INN)imatinib
Marketing-authorisation applicantActavis Group PTC ehf
Therapeutic indicationTreatment of Philadelphia-chromosome (bcr-abl)-positive (Ph+) chronic myeloid leukaemia (CML)
More informationSummary of opinion for Imatinib Actavis

 

Name of medicineMemantine LEK
INNmemantine
Marketing-authorisation applicantPharmathen S.A.
Therapeutic indicationTreatment of patients with moderate to severe Alzheimer’s disease
More informationSummary of opinion for Memantine LEK

 

Name of medicineMemantine Mylan
INNmemantine hydrochloride
Marketing-authorisation applicantGenerics [UK] Ltd.
Therapeutic indicationTreatment of patients with moderate to severe Alzheimer’s disease
More informationSummary of opinion for Memantine Mylan

 

Name of medicineNemdatine
INNmemantine hydrochloride
Marketing-authorisation applicantActavis Group PTC ehf
Therapeutic indicationTreatment of patients with moderate to severe Alzheimer’s disease
More informationSummary of opinion for Nemdatine

  

Re-examination of recommendation for new medicine

Name of medicineQsiva
INNphentermine / topiramate
Marketing-authorisation applicantVivus BV
Therapeutic indicationTreatment of obesity
More informationQuestions and answers on the refusal of the marketing authorisation for Qsiva

  

Positive recommendations on extensions of therapeutic indications

Name of medicineCervarix
Common namehuman papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, absored)
Marketing-authorisation holderGlaxoSmithKline 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 informationSummary of opinion for Cervarix

  

Name of medicinePrivigen
INNhuman normal immunoglobulin (Ivig)
Marketing-authorisation holderCSL 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 informationSummary of opinion for Privigen


Outcome of arbitration procedure

Name of medicineFurosemide Vitabalans 40 mg tablets
INNfurosemide
Marketing-authorisation holderVitabalans Oy
More informationFurosemide Vitabalans: Article-29(4) referral


Withdrawal of application

Name of medicineRuvise
INNimatinib mesilate
More informationRuvise: Withdrawn application


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

 

Related information

Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore, users are asked to check the page regularly.

Contact point:

Monika Benstetter 
Tel. +44 (0)20 7418 8427 
E-mail: press@ema.europa.eu