Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 February 2013
News 22/02/2013
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 medicine | Hexacima |
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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 |
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Name of medicine | Hexyon |
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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 |
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Positive recommendations on new hybrid medicines
Name of medicine | Pheburane |
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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 |
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Positive recommendations on new generic medicines
Name of medicine | Imatinib Actavis |
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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 |
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Name of medicine | Memantine LEK |
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INN | memantine |
Marketing-authorisation applicant | Pharmathen S.A. |
Therapeutic indication | Treatment of patients with moderate to severe Alzheimer's disease |
More information |
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Name of medicine | Memantine Mylan |
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INN | memantine hydrochloride |
Marketing-authorisation applicant | Generics [UK] Ltd. |
Therapeutic indication | Treatment of patients with moderate to severe Alzheimer's disease |
More information |
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Name of medicine | Nemdatine |
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INN | memantine hydrochloride |
Marketing-authorisation applicant | Actavis Group PTC ehf |
Therapeutic indication | Treatment of patients with moderate to severe Alzheimer's disease |
More information |
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Re-examination of recommendation for new medicine
Name of medicine | Qsiva |
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INN | phentermine / topiramate |
Marketing-authorisation applicant | Vivus BV |
Therapeutic indication | Treatment of obesity |
More information |
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Positive recommendations on extensions of therapeutic indications
Name of medicine | Cervarix |
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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 |
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Name of medicine | Privigen |
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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:
Immunomodulation in adults, and children and adolescents (0-18 years) in:
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More information |
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Outcome of arbitration procedure
Name of medicine | Furosemide Vitabalans 40 mg tablets |
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INN | furosemide |
Marketing-authorisation holder | Vitabalans Oy |
More information | Furosemide Vitabalans: Article-29(4) referral |
Withdrawal of application
Name of medicine | Ruvise |
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INN | imatinib mesilate |
More information | Ruvise: Withdrawn application |
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