MHRA marketing authorisation granted for Eli Lilly’s Verzenios as early breast cancer treatment
MHRA marketing authorisation granted for Eli Lilly’s Verzenios as early breast cancer treatment
MarketingauthorisationsgrantedinDecember2013 PLNumberGrantDateMAHolderLicensedName(s)ActiveSubstanceNameActiveIngredientUnitsLegalStatus PL04416/136603/12/2013SANDOZLIMITEDISTERANDA1.5MGTABLETSLEVONORGESTREL1.50MILLIGRAMMESPOM PL21806/007703/12/2013ACINOAGRENOCONTIN5MGPROLONGED-RELEASETABLETSOXYCODONEHYDROCHLORIDE5.0MILLIGRA...
MHRA marketing authorisation granted for Eli Lilly’s Verzenios as early breast cancer treatment
目前,全球已有多款CDK4/6抑制剂上市,除了礼来的Verzenio之外,还有辉瑞的Ibrance(palbociclib)以及诺华的Kisqali(ribociclib)。 参考来源: MHRA marketing authorisation granted for Eli Lilly’s Verzenios as early breast cancer treatment
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Lynparza (olaparib) as combination therapy with abiraterone and prednisone or prednisolone. AstraZeneca and MSD’s treatment is indicated for adults with metastatic castration-resistant prostate cancer (...
GenSight Biologics announced that its gene therapy LUMEVOQ® has been granted Promising Innovative Medicine designation by the UK’s Medicines and Healthcare products Regulatory Agency for the treatment of vision loss due to Leber Hereditary Optic Neuropathy caused by...
Marketing authorisation is based on positive Phase III ELATIVE trial data6 LONDON, U.K., 8 October, 2024– Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.K. Medicines and Healthcare products...
MHRA第三国GMP检查 Workshop on GMP/Pharmacopoeia/APIs
Today's decision follows regulatory approval by the European Medicines Agency on January 6. Its human medicines committeegranted a conditional marketing authorisationfor the vaccine in people aged 18 and over after an assessment of quality, safety, and efficacy. ...