Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 June 2012
This page lists the opinions adopted at the June 2012 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.
Users can view the main opinions adopted at the meeting, along with information on referral procedures, in a clear tabular format. Users can click on the links within the page to read individual press releases and more detailed information about the opinions.
The Agency publishes a new page following each month's CHMP meeting.
Positive recommendations on new medicines
| Name of medicine | Cuprymina |
|---|---|
| International non-proprietary name (INN) | copper (64Cu) chloride |
| Marketing-authorisation applicant | Sparkle S.r.l. |
| Therapeutic indication | Cuprymina is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal product must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide. |
| More information |
Summary of opinion for Cuprymina
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| Name of medicine | Revestive |
|---|---|
| International non-proprietary name (INN) | teduglutide |
| Marketing-authorisation applicant | Nycomed Danmark ApS |
| Therapeutic indication | Treatment of adult patients with short bowel syndrome. Patients should be stable following a period of intestinal adaptation after surgery. |
| More information |
| Name of medicine | Enurev Breezhaler / Seebri Breezhaler / Tovanor Breezhaler |
|---|---|
| International non-proprietary name (INN) | glycopyrronium bromide |
| Marketing-authorisation applicant | Novartis Europharm Ltd |
| Therapeutic indication | Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. |
| More information |
Summary of opinion for Enurev Breezhaler
Summary of opinion for Seebri Breezhaler
Summary of opinion for Tovanor Breezhaler
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| Name of medicine | Zinforo |
|---|---|
| International non-proprietary name (INN) | ceftaroline fosamil |
| Marketing-authorisation applicant | AstraZeneca AB |
| Therapeutic indication | Indicated in adults for the treatment of the following infections: complicated skin and soft tissue infections (cSSTI) / community-acquired pneumonia (CAP). Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
| More information |
Summary of opinion for Zinforo
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Negative recommendation on new medicine
| Name of medicine | Elelyso |
|---|---|
| International non-proprietary name (INN) | taliglucerase alfa |
| Marketing-authorisation applicant | Pfizer Ltd |
| Therapeutic indication | Treatment of type 1 Gaucher disease. |
| More information |
Questions and answers on Elelyso
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Positive recommendation on a new medicine for the use outside of the European Union
| Name of medicine | Hexaxim |
|---|---|
| International non-proprietary name (INN) | diptheria, tetanus, pertussis (acellular component), hepatitis B (rDNA), polimyelitis (inactivated) and Haemophilus influenzae type B conjugate vaccine (adsorbed) |
| Marketing-authorisation applicant | Sanofi Pasteur S.A. |
| Therapeutic indication | Hexaxim is indicated for 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 |
| More information |
Press release: European Medicines Agency gives first opinion for a vaccine for use outside the EU |
Positive recommendations on new generic medicines
| Name of medicine | Zoledronic acid Mylan |
|---|---|
| International non-proprietary name (INN) | zoledronic acid |
| Marketing-authorisation applicant | Mylan S.A.S. |
| Therapeutic indication | Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. The treatment of adult patients with tumour-induced hypercalcaemia. |
| More information |
Summary of opinion for Zoledronic acid Mylan
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| Name of medicine | Zyclara |
|---|---|
| International non-proprietary name (INN) | imiquimod |
| Marketing-authorisation applicant | Meda AB |
| Therapeutic indication | Topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic, visible or palpable actinic keratosis (AK) of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate. |
| More information |
Summary of opinion for Zyclara
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Positive recommendations on extensions of therapeutic indications
| Name of medicine | Afinitor |
|---|---|
| International non-proprietary name (INN) | everolimus |
| Marketing-authorisation holder | Novartis Europharm Ltd |
| Therapeutic indication (changes in bold) | Hormone receptor-positive advanced breast cancer
Afinitor is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
Neuroendocrine tumours of pancreatic origin
Afinitor is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.
Renal cell carcinoma
Afinitor is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy. |
| More information |
Summary of opinion for Afinitor
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| Name of medicine | Cayston |
|---|---|
| International non-proprietary name (INN) | aztreonam |
| Marketing-authorisation holder | Gilead Sciences International Ltd |
| Therapeutic indication (changes in bold) | Suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents. |
| More information |
Summary of opinion for Cayston
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| Name of medicine | Enbrel |
|---|---|
| International non-proprietary name (INN) | etanercept |
| Marketing-authorisation holder | Pfizer Ltd |
| Therapeutic indication (changes in bold) | Juvenile idiopathic arthritis
Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.
Enbrel has not been studied in children aged less than 2 years.
All other indications remain unchanged. |
| More information |
Summary of opinion for Enbrel
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| Name of medicine | Humira |
|---|---|
| International non-proprietary name (INN) | adalimumab |
| Marketing-authorisation holder | Abbott Laboratories Ltd |
| Therapeutic indication (changes in bold) | Axial spondyloarthritis
Ankylosing spondylitis (AS) Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Axial spondyloarthritis without radiographic evidence of AS
All other indications remain unchanged. |
| More information |
Summary of opinion for Humira
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Opinion on safety review of centrally authorised medicine
| Name of medicine | INN | Marketing-authorisation holder |
|---|---|---|
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Doribax
Press release: European Medicines Agency advises doctors treating patients with nosocomial pneumonia with Doribax | doripenem | Janssen-Cilag International N.V. |
Opinions on safety reviews of non-centrally authorised medicines
Opinions on arbitration procedures
| Name of medicine | INN | Marketing-authorisation holder |
|---|---|---|
| Loraxin | loratidine | Vitabalans Oy |
| Mifepristone Linepharma | mifepristone | Linepharma France |
Re-examination of arbitration procedure
| Name of medicine | INN | |
|---|---|---|
| Antifibrinolytic medicines | aprotinin, aminocaproic acid, tranexamic acid | |
Update on pharmacovigilance inspection
| Press release: Deficiencies identified in Roche safety reporting system |