Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 June 2012

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22/06/2012

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 medicineCuprymina
International non-proprietary name (INN)copper (64Cu) chloride
Marketing-authorisation applicantSparkle S.r.l.
Therapeutic indicationCuprymina 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 informationSummary of opinion for Cuprymina

  

Name of medicineRevestive
International non-proprietary name (INN)teduglutide
Marketing-authorisation applicantNycomed Danmark ApS
Therapeutic indicationTreatment of adult patients with short bowel syndrome. Patients should be stable following a period of intestinal adaptation after surgery.
More information

Summary of opinion for Revestive


Press release: European Medicines Agency recommends first medical treatment for patients with short bowel syndrome

 

Name of medicineEnurev Breezhaler / Seebri Breezhaler / Tovanor Breezhaler
International non-proprietary name (INN)glycopyrronium bromide
Marketing-authorisation applicantNovartis Europharm Ltd
Therapeutic indicationMaintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease.
More informationSummary of opinion for Enurev Breezhaler
Summary of opinion for Seebri Breezhaler
Summary of opinion for Tovanor Breezhaler

 

Name of medicineZinforo
International non-proprietary name (INN)ceftaroline fosamil
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationIndicated 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 informationSummary of opinion for Zinforo


Negative recommendation on new medicine

Name of medicineElelyso
International non-proprietary name (INN)taliglucerase alfa
Marketing-authorisation applicantPfizer Ltd
Therapeutic indicationTreatment of type 1 Gaucher disease.
More informationQuestions and answers on Elelyso


Positive recommendation on a new medicine for the use outside of the European Union

Name of medicineHexaxim
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 applicantSanofi Pasteur S.A.
Therapeutic indicationHexaxim 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

Summary of opinion for Hexaxim

 

Press release: European Medicines Agency gives first opinion for a vaccine for use outside the EU

 

Positive recommendations on new generic medicines

Name of medicineZoledronic acid Mylan
International non-proprietary name (INN)zoledronic acid
Marketing-authorisation applicantMylan S.A.S.
Therapeutic indicationPrevention 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 informationSummary of opinion for Zoledronic acid Mylan

 

Name of medicineZyclara
International non-proprietary name (INN)imiquimod
Marketing-authorisation applicantMeda AB
Therapeutic indicationTopical 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 informationSummary of opinion for Zyclara


Positive recommendations on extensions of therapeutic indications 

Name of medicineAfinitor
International non-proprietary name (INN)everolimus
Marketing-authorisation holderNovartis 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 informationSummary of opinion for Afinitor

 

Name of medicineCayston
International non-proprietary name (INN)aztreonam
Marketing-authorisation holderGilead 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 informationSummary of opinion for Cayston

 

Name of medicineEnbrel
International non-proprietary name (INN)etanercept
Marketing-authorisation holderPfizer 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 informationSummary of opinion for Enbrel

  

Name of medicineHumira
International non-proprietary name (INN)adalimumab
Marketing-authorisation holderAbbott 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 informationSummary of opinion for Humira

  
Opinion on safety review of centrally authorised medicine

Name of medicineINNMarketing-authorisation holder
Doribax

Press release: European Medicines Agency advises doctors treating patients with nosocomial pneumonia with Doribax
doripenemJanssen-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

 

Opinions on arbitration procedures

Name of medicineINNMarketing-authorisation holder
LoraxinloratidineVitabalans Oy
Mifepristone LinepharmamifepristoneLinepharma France


Re-examination of arbitration procedure

Name of medicineINN
Antifibrinolytic medicinesaprotinin, aminocaproic acid, tranexamic acid


Update on pharmacovigilance inspection

Press release: Deficiencies identified in Roche safety reporting system


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 during the June 2012 CHMP meeting
Overview of invented names reviewed in May 2012 by the Name Review Group (NRG)
Organisational matters

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