Edition:
United States

EMA Says CHMP Recommends Granting A Conditional Marketing Authorisation For Waylivra


Friday, 1 Mar 2019 08:16am EST 

March 1 (Reuters) - EMA - :EMA - CHMP RECOMMENDED GRANTING A CONDITIONAL MARKETING AUTHORISATION FOR ONDEXXYA.EMA - CHMP RECOMMENDED GRANTING A CONDITIONAL MARKETING AUTHORISATION FOR WAYLIVRA.EMA - ZYNQUISTA INTENDED AS AN ADJUNCT TO INSULIN FOR CERTAIN PATIENTS WITH TYPE 1 DIABETES, RECEIVED A POSITIVE OPINION FROM CHMP.EMA - CHMP ADOPTED A POSITIVE OPINION, RECOMMENDING GRANTING OF A CONDITIONAL MARKETING AUTHORISATION FOR LORVIQUA.EMA - CHMP RECOMMENDED FOR APPROVAL GENERIC MEDICINE PAZENIR FOR TREATMENT OF METASTATIC BREAST CANCER AND NON-SMALL CELL LUNG CANCER.EMA - APPLICANT FOR DOXOLIPAD HAS REQUESTED A RE-EXAMINATION OF COMMITTEE'S NEGATIVE OPINION FOR THIS MEDICINE ADOPTED AT JANUARY 2019 MEETING.EMA - CHMP RECOMMENDED EXTENSION OF INDICATION OF DUPIXENT AS ADD-ON MAINTENANCE TREATMENT FOR PATIENTS 12 YRS & OLDER WITH FORMS OF SEVERE ASTHMA.EMA - CHMP WILL NOW RE-EXAMINE OPINION FOR DOXOLIPAD AND ISSUE A FINAL RECOMMENDATION.EMA - APPLICATION FOR AN INITIAL MARKETING AUTHORISATION FOR EPJEVY (PACRITINIB CITRATE) WAS WITHDRAWN.EMA - OTHER EXTENSIONS OF INDICATION RECOMMENDED BY COMMITTEE WERE FOR LYNPARZA, RIARIFY, TRYDONIS AND VIREAD. 

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