opdivo inn: 'nivolumab' · start of procedure: 17 september 2016 chmp co-rapporteur assessment...

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AUSTRALIAN PRODUCT INFORMATION OPDIVO (NIVOLUMAB)€¦ · Attachment 1: Product AusPAR Opdivo nivolumab Bristol-Myers Squibb Australia Pty.Ltd. PM-2017-02209-1-4 FINAL 24 January

Procedural Advice to CHMP Members · requiring appointment of Rapporteur/Co-Rapporteur at the next meeting. CHMP members wishing to act as Rapporteur/Co-Rapporteur for a given product

Committee for medicinal products for human use (CHMP) · Committee for medicinal products for human use (CHMP) EMA/CHMP/556731/2019 Page 2/38 Table of contents

Assessment report - European Medicines Agency · Submission date 7 December 2015 Start of procedure: 3 January 2016 CHMP Rapporteur Assessment Report 18 February 2016 PRAC Rapporteur

CHMP assessment report - European Medicines Agency€¦ · 22 May 2014 . EMA/CHMP/231450/2014 . Committee for Medicinal Products for Human Use (CHMP) CHMP assessment report . Gazyvaro

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Opdivo, INN - nivolumab...Assessment report EMA/216066/2016 Page 7/84 2. Scientific discussion 2.1. Introduction Opdivo (nivolumab) is a human immunoglobulin G4 (IgG4) monoclonal antibody

Assessment report · The Co-Rapporteur's first Assessment Report was circulated to all CHMP members on 13 March 2015. • The first PRAC Rapporteur Risk Management Plan (RMP) Assessment

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CHMP assessment report€¦ · CHMP assessment report EMA/CHMP/208477/2013 Page 9/136 September 2012. The Co-Rapporteur's first Assessment Report was circulated to all CHMP members

Assessment report · Request for supplementary information (RSI) 14 December 2017 CHMP Rapporteur Assessment Report 19 February 2018 PRAC Rapporteur Assessment Report 20 February

Assessment report - European Medicines Agency · March 2016. • The Rapporteur circulated the Assessment Report on the applicant’s responses to the List of Questions to all CHMP

CHMP assessment report - European Medicines Agency · CHMP assessment report Envarsus EMA/CHMP/81205/2014 Page 5/118 . List of abbreviations . ADME Absorption and bioavailability,

CHMP extension of indication variation assessment report · CHMP extension of indication variation assessment report EMA/CHMP/647625/2019 Page 8/88 The majority of EGFR mutations

CHMP assessment report - ema.europa.eu · During its meeting on 21 July 2011, the CHMP appointed David Lyons as Rapporteur and Conception Prieto Yerro as Co-Rapporteur. The applicant

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International Nonproprietary Name: gemtuzumab ozogamicin...• During its meeting on 15-18 October 2007, the CHMP appointed Tomas Salmonson as Rapporteur and David Lyons as Co-Rapporteur

CHMP assessment report for paediatric use studies ......21 November 2013 EMA/CHMP/780068/2013 Committee for Medicinal Products for Human Use (CHMP) Synagis (Palivizumab) Procedure

CHMP assessment report - ema.europa.eu · 20 February 2014 . EMA/CHMP/175692/2014 . Committee for Medicinal Products for Human Use (CHMP) CHMP assessment report . DuoResp Spiromax

OPDIVO (nivolumab) injection, for intravenous use · 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OPDIVO safely and effectively

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CHMP assessment report - European Medicines Agency€¦ · CHMP assessment report EMA/CHMP/272283/2016 Page 3/86 intolerant to or have medical contraindications for such therapies

ALPROLIX, INN-eftrenonacog alfa · The Rapporteur and Co-Rapporteur appointed by the CH MP were: Rapporteur: Andrea Laslop Co-Rapporteur: Concepcion Prieto Yerro • The application

OPDIVO, INN-nivolumab

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Assessment report - ema.europa.eu€¦ · CHMP Rapporteur Updated Assessment Report 17 April 2015 Opinion 23 April 2015 . 2. Scientific discussion 2.1. Introduction Invega tablets

AUSTRALIAN PRODUCT INFORMATION OPDIVO …Attachment 1: Product information for AusPAR Opdivo Nivolumab BMS Australia PM-2017-03752-1-4 Final 6 August 2018 This Product information

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OPDIVO - Medicines.org.au · OPDIVO® (op-DEE-voh) Nivolumab (nee-vol-u-mab) Consumer Medicine Information WARNINGS AND PRECAUTIONS - COMBINATION OF OPDIVO AND YERVOY Both OPDIVO

CHMP extension of indication variation assessment …...London, 25 April 2014 EMA/CHMP/220738/2014 Committee for Medicinal Products for Human Use (CHMP) CHMP extension of indication