Transcription of Recommendations of the SEC (Oncology &Haematology) …
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Recommendations of the SEC (Oncology &Haematology) …
70thSEC (Oncology &Haematology) Recommendations of the SEC (Oncology &Haematology) made in its 70thmeeting held on at CDSCO HQ New Delhi: Agenda No File name & drug name , Strength Firm name Recommendations Introductory remarks New Drugs Division 1 12-05/14-DC (Pt-Phase-IV) Enzalutamide 40mg capsules (Phase-IV) M/s. Astellas Pharma The firm presented the Phase IV clinical trial protocol before the committee. With a request for waiver of PK assessment. After detailed deliberation, the committee recommended for grant of permission to conduct the Phase IV clinical trial as per the protocol presented. SubsequentNew Drugs Division 2 12-10/2017-DC (Pt-Johnson-snd) Ibrutinib 140mg capsule (add.)
70thSEC (Oncology &Haematology)_ 23.05.2018 Agen da No File Name & Drug Name, Strength Firm Name Recommendations for the treatment of adult patients …
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