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Home  /  Forum  /  Tigenix  /  Tigenix december

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Tigenix december

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2.244 Posts
Pagina: «« 1 ... 53 54 55 56 57 ... 113 »» | Laatste | Omlaag ↓
  17. forum rang 10 DeZwarteRidder 15 december 2017 13:09
    Alofisel
    darvadstrocel
    On 14 December 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Alofisel, intended for the treatment of complex perianal fistulas in patients with Crohn’s disease. As Alofisel is an advanced therapy medicinal product, the CHMP positive opinion is based on an assessment by the Committee for Advanced Therapies. Alofisel was designated as an orphan medicinal product on 8 October 2009. The applicant for this medicinal product is Tigenix, S.A.U.
    Alofisel will be available as a suspension for injection (5 million cells/ml). The active substance of Alofisel is darvadstrocel. Darvadstrocel contains expanded adipose stem cells which, once activated, impair proliferation of lymphocytes and reduce the release of pro-inflammatory cytokines at inflammation sites. This immunoregulatory activity reduces inflammation and may allow the tissues around the fistula tract to heal.
    The benefits with Alofisel are its ability to improve the healing process of complex perianal fistulas in patients with Crohn’s disease. The most commonly reported side effects include anal abscess and fistula, as well as procedural pain and proctalgia.
  18. [verwijderd] 15 december 2017 13:09
    Positive recommendations on new medicines
    Name of medicine Alofisel
    INN darvadstrocel
    Marketing-authorisation applicant Tigenix, S.A.U.
    Therapeutic indication Treatment of complex perianal fistulas in patients with Crohn’s disease
    More information
    Summary of opinion for Alofisel



    Press release: New medicine to treat perianal fistulas in patients with Crohn’s disease

2.244 Posts
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