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Committee for Medicinal Products for Human Use (CHMP)

CHMP adopts positive opinion of Edurant in adolescents with HIV-1

26 October 2015 | By Victoria White

If approved by the European Commission, Edurant will become available for the treatment of adolescents with HIV-1 for the first time...

CHMP recommends approval of Cosentyx for ankylosing spondylitis and psoriatic arthritis

23 October 2015 | By Victoria White

Cosentyx Phase III studies have consistently demonstrated significant improvements in the signs and symptoms of ankylosing spondylitis and psoriatic arthritis...

CHMP recommends Cotellic and Zelboraf combo in advanced melanoma

25 September 2015 | By Victoria White

The CHMP’s recommendation is based primarily on results of a Phase III study that showed that people who received the combination of Cotellic and Zelboraf lived over a year without their disease worsening...

CHMP adopts positive opinion of Genvoya for HIV-1

25 September 2015 | By Victoria White

The CHMP’s recommendation will now be reviewed by the European Commission. If approved, Genvoya would be Gilead’s first single tablet regimen to contain TAF...

CHMP issues positive opinion for idarucizumab, the reversal agent for dabigatran

25 September 2015 | By Victoria White

Idarucizumab is intended for use in patients treated with dabigatran who require immediate anticoagulant reversal prior to urgent procedures or in case of uncontrolled bleeding...

CHMP adopts positive opinion of azacitidine for elderly patients with AML

25 September 2015 | By Victoria White

The CHMP adopted a positive opinion for an expanded indication of azacitidine for the treatment of adult patients aged 65 years or older with acute myeloid leukaemia who are not eligible for haematopoietic stem cell transplantation...

CHMP recommends heart failure drug Entresto

25 September 2015 | By Victoria White

The CHMP has adopted a positive opinion for Novartis’ Entresto (sacubitril/valsartan), marking an important milestone towards the drug becoming available in the EU.

CHMP grants label extension for GSK’s Synflorix

30 July 2015 | By Victoria White

CHMP has granted a label extension for Synflorix to include protection against IPD caused by pneumococcal serotype 19A in children aged 6 weeks to 5 years...

CHMP adopts positive opinion of Obizur for haemophilia A

28 July 2015 | By Victoria White

The CHMP has adopted a positive opinion for the marketing authorisation of Obizur for the treatment of bleeding episodes in patients with haemophilia...

CHMP recommends Revolade for severe aplastic anaemia

27 July 2015 | By Victoria White

CHMP has adopted a positive opinion for Revolade for the treatment of patients with severe aplastic anaemia who have had an insufficient response to IST...

CHMP recommends approval of isavuconazole in the EU

27 July 2015 | By Victoria White

CHMP has adopted a positive opinion recommending the approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis...

Keryx’s hyperphosphatemia treatment Fexeric backed for European approval

24 July 2015 | By Victoria White

The CHMP has adopted a positive opinion for on marketing authorisation of Fexeric, recommending its approval for the treatment of hyperphosphatemia in CKD...

Shire receives CHMP positive opinion for ADHD drug Intuniv

24 July 2015 | By Victoria White

The CHMP has adopted a positive opinion recommending the approval of Shire’s Intuniv for the treatment of ADHD in children and adolescents...

CSL Behring receives positive CHMP opinion for Respreeza

29 June 2015 | By Victoria White

The Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation in the EU for CSL Behring's Respreeza...

Perjeta recommended for approval in EU for use before surgery in HER2-positive early breast cancer

29 June 2015 | By Victoria White

The CHMP has recommended that the EC approves the use of Perjeta for the neoadjuvant treatment of adult patients with HER2-positive early breast cancer...

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