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Monday 20 May 2019
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Topic: chmp

April 4, 2016
If approved, TREVICTA® will be the first treatment for schizophrenia to be administered four times a year and will provide the longest dosing interval available for an antipsychotic medication in the European Union

February 29, 2016
Sobi and Biogen received a positive opinion from CHMP of the European Medicines Agency recommending that marketing authorisation be granted for Alprolix®

October 26, 2015
IMLYGIC is first oncolytic immunotherapy to demonstrate therapeutic benefit for patients with advanced melanoma

Amgen announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending that IMLYGIC™ (talimogene laherparepvec) be granted approval for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. If approved by the European Commission, IMLYGIC would be the first in a class of novel agents known as oncolytic immunotherapies.

September 25, 2015
Daratumumab is for treatment of European patients with heavily pre-treated multiple myeloma

Janssen-Cilag International NV announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has accepted its request for an accelerated assessment of the daratumumab Marketing Authorisation Application (MAA). This acceptance follows the earlier regulatory submission of a MAA, which seeks authorisation of daratumumab as a single agent for the treatment of patients with relapsed and refractory, multiple myeloma and is currently pending validation by the EMA.
 

September 25, 2015
Positive opinion from EU review body puts Entresto (sacubitril valsartan) on track to be approved for HFrEF patients across Europe by the end of 2015

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Entresto™ (sacubitril valsartan). Pending final approval by the European Commission (EC), Entresto (sacubitril valsartan), previously known as LCZ696, will be licensed for use in the UK for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction (HFrEF).

 

June 10, 2015
Merck Sharp & Dohme (MSD), known as Merck in the United States and Canada, announced additional data from a subanalysis (1) of the multicentre, randomised, double-blind, placebo-controlled GO-AHEAD study on the effect of SIMPONI® (golimumab) in treating patients with non-radiographic axial spondyloarthritis (nr-axial SpA). (2)

Merck Sharp & Dohme (MSD), known as Merck in the United States and Canada, announced additional data from a subanalysis (1) of the multicentre, randomised, double-blind, placebo-controlled GO-AHEAD study on the effect of SIMPONI® (golimumab) in treating patients with non-radiographic axial spondyloarthritis (nr-axial SpA). (2)
 

May 6, 2015
Swedish Orphan Biovitrum AB (publ) (Sobi) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the oral suspension formulation and the 20mg capsule of Orfadin (nitisinone) for the treatment of hereditary tyrosinaemia type-1 (HT-1). HT-1 is a rare genetic disease that affects infants and children; it is progressive in nature, may result in liver and kidney failure and can be fatal if untreated.

Swedish Orphan Biovitrum AB (publ) (Sobi) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the oral suspension formulation and the 20mg capsule of Orfadin (nitisinone) for the treatment of hereditary tyrosinaemia type-1 (HT-1). HT-1 is a rare genetic disease that affects infants and children; it is progressive in nature, may result in liver and kidney failure and can be fatal if untreated.  

December 19, 2014
Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for expanded use of Tresiba® (insulin degludec) in children and adolescents aged 1–17 years with diabetes. Once the European Commission approves the licence extension, physicians in the European Union will be able to prescribe insulin degludec to children and adolescents aged 1–17 with type 1 and type 2 diabetes.

Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for expanded use of Tresiba® (insulin degludec) in children and adolescents aged 1–17 years with diabetes. Once the European Commission approves the licence extension, physicians in the European Union will be able to prescribe insulin degludec to children and adolescents aged 1–17 with type 1 and type 2 diabetes.

November 21, 2014
Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for OTEZLA® (apremilast), the company’s oral selective inhibitor of phosphodiesterase 4 (PDE4), in two therapeutic indications.

Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for OTEZLA® (apremilast), the company’s oral selective inhibitor of phosphodiesterase 4 (PDE4), in two therapeutic indications: (1)
 

July 3, 2014
Bayer HealthCare has announced that EYLEA has been recommended for approval by the European Committee for Medicinal Products for Human Use for the treatment of visual impairment due to diabetic macular oedema.

Bayer HealthCare has announced that EYLEA has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of visual impairment due to diabetic macular oedema (DMO).(1)

June 1, 2009
Novartis has received a CHMP positive opinion supporting EU approval of Afinitor

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May 29, 2009
EMEA positive opinion on the rotigotine transdermal patch for patients with Parkinson's disease

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May 6, 2009
Committee for Medicinal Products for Human Use (CHMP) recommends approval of Novo Nordisk's Victoza (liraglutide) for type 2 diabetes

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March 23, 2009
The European Medicines Agency

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November 21, 2008
Rasilez HCT receives recommendation for EU approval as a single-pill combination to treat high blood pressure

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August 6, 2008
Prostate cancer drug designed to help those who have not responded to chemotherapy is withdrawn

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July 17, 2008
FDA committee follows CHMP in advising approval of nosocomial pneumonia treatment

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July 7, 2008
EC approval expected soon for the first new NNRTI in nearly ten years

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June 2, 2008
CHMP recommends approval of Doribax for nosocomial pneumonia

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April 29, 2008
EU extend marketing authorisation for Zevalin

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April 29, 2008
The EU are set to approve HAE treatment, while US authorities issue a rejection

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April 25, 2008
Neupro recommended for approval in Europe for Restless Legs Syndrome

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March 25, 2008
Belgium's UCB has suffered a major blow after EU advisers upheld a negative opinion on certolizumab pegol for Crohn

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January 29, 2008
The CHMP has advised refusal of marketing authorisation for lenalidomide, aimed at treating anaemia due to myelodysplasia

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