Start of community reviews CHMP meeting of 11-14 September 2017
Table 1. Start of arbitration procedure Name
INN
Type of procedure
Scope
Scandonest
Mepivacaine
Article 30 of Directive
The Committee started a harmonisation
2001/83/EC
exercise for Scandonest and associated
and associated names
names. The review was triggered by the Marketing Authorisation Holder, due to the need of harmonisation of the Summary of Product Characteristics across Member States. More information is available here.
Start of community review - September 2017 - European Medicines ...
Sep 14, 2017 - An agency of the European Union. Telephone +44 ... Send a question via our website www.ema.europa.eu/contact ... Article 30 of Directive.
Sep 14, 2017 - An agency of the European Union. Telephone +44 ... Send a question via our website www.ema.europa.eu/contact ... Article 30 of Directive.
Oct 13, 2017 - applications for initial evaluations, extensions, variations and renewals concerning marketing authorisations (MAs); ... Initial evaluation of marketing authorisation applications. 2014. 2015. 2016 .... Out of scope. 1 Establishment of
Sep 1, 2017 - For information: WHO online consultation on the monitoring and ... Information relating to availability of medicines cannot be released at the ...
European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 3 October 2017. EMA/CVMP/659549/2017. Committee for ... Minutes of the 5-7 September 2017 meeting. Chair: D. Murphy ..... shellfish diseases held on 4-8
Oct 3, 2017 - Full involvement. SI. Petra Segina â remotely. Full involvement. UK. Miguel Escribano â remotely. Full involvement. UK. Sam Fletcher â remotely. Full involvement. UK. Sharon Reynolds â remotely. Full involvement. CVMP working pa
Oct 20, 2017 - Scope: âExtension application for a new pharmaceutical form (Exjade 90, 180 and 360 mg granules).â Action: For adoption ...... 2.0 has also been submitted. 3) C.I.3.z (type IB). Update of section 4.5 of the SmPC to implement the wo
Nov 27, 2017 - Minutes of the meeting on 25-29 September 2017. Chair: June Raine â Vice-Chair: Almath Spooner. Health and safety information. In accordance with the Agency's health and safety policy, delegates were briefed on health, safety and eme
Oct 20, 2017 - Coordination with EMA Working Parties/Working Groups/Drafting Groups ......... 52. 14.3.1. ...... The CHMP agreed to the draft list of experts to the ad hoc expert group and adopted a list of questions to this ..... The CHMP nominated
Sep 25, 2017 - and may also change during the course of the review. ...... Scope: Update of section 5.1 of the SmPC based on new clinical data from a ...
Sep 16, 2016 - Election of Pierre Demolis as Chair to the Oncology Working party. â¢. Election of Karl Broich as Chair to the Central Nervous System Working ...
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Jul 10, 2017 - Send a question via our website www.ema.europa.eu/contact ... and Social Protection-Republic of Kenya and EAC Secretariat, undertook ... networking Agency, based on the experience and lessons learned at EMA. ... Page 3 ...
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Jul 5, 2017 - Send a question via our website www.ema.europa.eu/contact ... non-proprietary names (INN) and therapeutic areas for all new ... also available in the monthly reports of the Committee for Orphan Medicinal Products (COMP).
Oct 27, 2017 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. Telephone +44 (0)20 3660 6000 ... This document provides current information related to the volume and evaluation of marketing authorisation and ... The purpose
May 8, 2017 - Information Management Division ... This document provides current information related to the volume and evaluation of .... Plasma master file.
Feb 13, 2017 - Monthly report on application procedures, guidelines and .... of MRLs for new substances under article 3 of Regulation (EC) No 470/2009.
