The CHAMP issued a favorable opinion on the granting of the marketing authorization:
-Spherox (autologous human chondrocytes associated with a matrix) in the treatment of symptomatic articular cartilaginous knee lesions in adults with a surface area of not more than 10 cm2.
- Oxervate (cenégermine) in the treatment of moderate to severe neurotrophic keratitis. Oxervate has an orphan drug designation.
- Reagila (cariprazine) in the treatment of schizophrenia.
- Kyntheum (brodalumab) in the treatment of moderate to severe plaque psoriasis.
- Trimbow (beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium) in moderate to severe chronic obstructive pulmonary disease.
-Veltassa (patiromer) in the treatment of hyperkalaemia.
For 4 biosimilar drugs:
- Insulin lispro Sanofi (insulin lispro) in the treatment of diabetes mellitus.
- Blitzima (rituximab)
- Tuxella (rituximab) in the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.
- Ritemvia (rituximab) in the treatment of non-Hodgkin's lymphoma, granulomatosis with polyangiitis and microscopic polyangiitis.
As well as for the generic medicine:
Efavirenz / Emtricitabine / Tenofovir disoproxil Zentiva (efavirenz / emtricitabine / tenofovir disoproxil) for the treatment of HIV infection.
Three cases received a negative opinion from the CHMP:
-Adlumiz (anamorelin hydrochloride) for which an AMM was used in the treatment of anorexia, cachexia and unintended weight loss in patients with non-small cell lung cancer.
- The human monoclonal antibody IgG1 specific for interleukin A alpha XBiotech for which an AMM was requested for the treatment of symptoms related to advanced colorectal cancer.
- Masipro (masitinib) for which a marketing authorization was requested in the treatment of systemic mastocytosis.
http://www.ansm.com
Friday, June 23, 2017
Among the medical products that will be marketed sooner.
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