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	CHMP summary of positive opinion for Cuprymina

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	CHMP summary of positive opinion for Revestive Press release: European Medicines Agency recommends first medical treatment for patients with short bowel syndrome

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	CHMP summary of positive opinion for Enurev Breezhaler CHMP summary of positive opinion for Seebri Breezhaler CHMP summary of positive opinion for Tovanor Breezhaler

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	CHMP summary of positive opinion for Zinforo

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 refusal of the marketing authorisation for Elelyso

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	CHMP summary of positive opinion for Zoledronic acid Mylan

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	CHMP summary of positive opinion for Zyclara

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	CHMP post-authorisation summary of positive opinion for Afinitor

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	CHMP post-authorisation summary of positive opinion for Cayston

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	CHMP post-authorisation summary of positive opinion for Enbrel

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 Humira is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. All other indications remain unchanged.
More information	CHMP post-authorisation summary of positive opinion for Humira

Opinion on safety review of centrally authorised medicine

Name of medicine	INN	Marketing-authorisation holder
Questions and answers on the review of Doribax (doripenem) 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

Name of medicine
Tolperisone-containing medicines Press release: European Medicines Agency recommends restricting use of tolperisone medicines
Trimetazidine-containing medicines Press release: European Medicines Agency recommends restricting use of trimetazidine-containing medicines

Name of medicine

Tolperisone-containing medicines

Press release: European Medicines Agency recommends restricting use of tolperisone medicines

Trimetazidine-containing medicines

Press release: European Medicines Agency recommends restricting use of trimetazidine-containing medicines