At the start of its October 2012 meeting, the Committee for Medicinal Products for Human Use (CHMP) elected Dr Ian Hudson as its new vice-chair for a three-year mandate.
Dr Hudson brings outstanding experience and expertise from a long career in regulatory medicine and drug development, particularly in the areas of anti-infectives and oncology. He currently holds the position of Director of the Licensing Division at the Medicines and Healthcare Products Regulatory Agency in London. Dr Hudson has been a member of the CHMP since 2004.
The opinions adopted by the CHMP at the October 2012 meeting and other important outcomes are listed in the table below.
The Agency publishes a new page following each month's CHMP meeting.
Positive recommendations on new medicines
Name of medicine | Amyvid |
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International non-proprietary name (INN) | florbetapir (18F) |
Marketing-authorisation applicant | Eli Lilly Nederland BV |
Therapeutic indication | Radiopharmaceutical indicated for positron-emission-tomography (PET) imaging of ?-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment |
More information | CHMP summary of positive opinion for Amyvid
|
Name of medicine | Betmiga |
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INN | mirabegron |
Marketing-authorisation applicant | Astellas Pharma Europe BV |
Therapeutic indication | Treatment of overactive bladder syndrome |
More information | CHMP summary of positive opinion for Betmiga |
Name of medicine | Krystexxa |
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INN | pegloticase |
Marketing-authorisation applicant | Savient Pharma Ireland Ltd |
Therapeutic indication | Treatment of chronic gout |
More information | CHMP summary of positive opinion for Krystexxa |
Name of medicine | Tresiba |
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INN | insulin degludec |
Marketing-authorisation applicant | Novo Nordisk A/S |
Therapeutic indication | Treatment of diabetes mellitus |
More information |
Name of medicine | Ryzodeg |
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INN | insulin degludec / insulin aspart |
Marketing-authorisation applicant | Novo Nordisk A/S |
Therapeutic indication | Treatment of diabetes mellitus |
More information | CHMP summary of positive opinion for Ryzodeg |
Negative recommendations on new medicines
Name of medicine | Acrescent |
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INN | memantine hydrochloride / donepezil hydrochloride |
Marketing-authorisation applicant | H. Lundbeck A/S |
Therapeutic indication | Treatment of Alzheimer's disease |
More information | Questions and answers on the refusal of the marketing authorisation for Acrescent |
Name of medicine | Balaxur |
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INN | memantine hydrochloride / donepezil hydrochloride |
Marketing-authorisation applicant | Merz Pharmaceuticals GmbH |
Therapeutic indication | Treatment of Alzheimer's disease |
More information | Questions and answers on the refusal of the marketing authorisation for Balaxur |
Name of medicine | Qsiva |
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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) |
Positive recommendations on extensions of therapeutic indications
Name of medicine | Humira |
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INN | adalimumab |
Marketing-authorisation holder | Abbott Laboratories Ltd |
New therapeutic indication | Paediatric Crohn's disease Humira is indicated for the treatment of severe active Crohn's disease in paediatric patients (6 to 17 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications for such therapies. |
More information | CHMP post-authorisation summary of positive opinion for Humira |
Name of medicine | Isentress |
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INN | raltegravir |
Marketing-authorisation holder | Merck Sharp & Dohme Ltd |
Therapeutic indication (changes in bold) | Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, and children from the age of 2 years. |
More information | CHMP post-authorisation summary of positive opinion for Isentress |
Name of medicine | Thyrogen |
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INN | thyrotropin alfa |
Marketing-authorisation holder | Genzyme Europe BV |
Therapeutic indication (changes in bold) | Thyrogen is indicated for use with serum thyroglobulin (Tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone suppression therapy (THST). Low-risk patients with well-differentiated thyroid carcinoma who have undetectable serum Tg levels on THST and no rh (recombinant human) TSH-stimulated increase of Tg levels may be followed-up by assaying rh TSH-stimulated Tg levels. Thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mCi (1.1 GBq) to 100 mCi (3.7 GBq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.4). |
More information | CHMP post-authorisation summary of positive opinion for Thyrogen |
Name of medicine | Xarelto |
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INN | rivaroxaban |
Marketing-authorisation holder | Bayer Pharma AG |
Therapeutic indication (changes in bold) | Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep-vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.) |
More information | CHMP post-authorisation summary of positive opinion for Xarelto |
Positive recommendations on new generic medicines
Name of medicine | Imatinib Teva |
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INN | imatinib |
Marketing-authorisation applicant | Teva Pharma BV |
Therapeutic indication | Treatment of leukaemia |
More information | CHMP summary of positive opinion for Imatinib Teva |
Outcomes of arbitration procedures
Name of medicine | INN | Marketing-authorisation applicant |
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Furosemide Vitabalans | furosemide | Vitabalans Oy |
Levothyroxine Alapis | levothyroxine | Alapis SA |
Re-examination of arbitration procedure
Name of medicine | INN | Marketing-authorisation applicant |
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Loraxin | loratadine | Vitabalans Oy |
Re-examination of safety review
Name of medicine |
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Tolperisone-containing medicines |
Outcomes of Art.5(3) reviews