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Monday 22 October 2018
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Topic: chmp positive opinion

October 19, 2017
CHMP recommends to broaden indication to include the treatment of men with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer

Janssen-Cilag International NV has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended broadening the existing marketing authorisation for Zytiga® (abiraterone acetate) plus prednisone / prednisolone to include an earlier stage of prostate cancer than its current indications.

 

July 25, 2017
Novel compound belongs to an emerging form of treatments called peptide receptor radionuclide therapy, which involves targeting tumours with radiolabelled molecules that bind to specific receptors expressed by the tumour

Advanced Accelerator Applications S.A has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the marketing authorisation of lutetium (177Lu) oxodotreotide (Lutathera®) for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.
 

July 21, 2017
First investigational targeted biologic in the European Union to receive positive CHMP opinion for atopic dermatitis

Sanofi and Regeneron Pharmaceuticals, Inc have announced that the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorisation of Dupixent® (dupilumab), recommending its approval in Europe for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

 

September 16, 2016
If approved, Stelara® will be the first interleukin (IL)-12/23 inhibitor licensed for Crohn’s disease

September 16, 2016
Novo Nordisk today announced that the CHMP has adopted a positive opinion to extend the use of NovoRapid® (insulin aspart) in the EU for children with diabetes from as young as one year old

June 26, 2015
Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the expanded use of Levemir® (insulin detemir) in children with diabetes as young as one year old

There are an estimated 497,100 children living with type I diabetes globally and incidence is increasing in many countries. (1) Young children with type I diabetes can be difficult to treat as their needs are in constant flux during growth and development, (2) with children aged six and under at greatest risk of severe hypoglycaemia and acute diabetes complications. (3)
 

 

April 27, 2015
The European Committee for Medicinal Products for Human Use recommended approval of once-daily Lixiana®. The positive opinion is based on data from the ENGAGE AF-TIMI 48 and Hokusai-VTE studies, the largest single comparative global trials of a novel oral anticoagulant in patients with non-valvular atrial fibrillation or venous thromboembolism, involving 21,105 and 8,292 patients, respectively. Daiichi Sankyo looks forward to receiving approval decision by the European Commission soon, which is the basis for marketing authorisation in all European Union member states.
  • The European Committee for Medicinal Products for Human Use recommended approval of once-daily Lixiana®.
  •  The positive opinion is based on data from the ENGAGE AF-TIMI 48 and Hokusai-VTE studies, the largest single comparative global trials of a novel oral anticoagulant in patients with non-valvular atrial fibrillation or venous thromboembolism, involving 21,105 and 8,292 patients, respectively. 
November 24, 2014
The Committee for Medicinal Products for Human Use (CHMP) today issued a positive opinion for the use of Victoza® (liraglutide) in adults with type 2 diabetes and moderate renal impairment. Once the European Commission approves the label expansion, physicians in the European Union will be able to prescribe Victoza®, the once-daily human glucagon-like peptide-1 (GLP-1) analogue, to adults with type 2 diabetes and moderate renal impairment without dose adjustments.

The Committee for Medicinal Products for Human Use (CHMP) today issued a positive opinion for the use of Victoza® (liraglutide) in adults with type 2 diabetes and moderate renal impairment. Once the European Commission approves the label expansion, physicians in the European Union will be able to prescribe Victoza®, the once-daily human glucagon-like peptide-1 (GLP-1) analogue, to adults with type 2 diabetes and moderate renal impairment without dose adjustments.

 

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