Committee for medicinal products for human use (CHMP)
2eO29eq
2eO29eq
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1. Introduction<br />
1.1. Welcome and declarations of interest of members, alternates and<br />
experts<br />
Pre-meeting list of participants and restrictions in relation to declarations of interests<br />
applicable to the items of the agenda <strong>for</strong> the <strong>CHMP</strong> plenary session to be held 07-10 November<br />
2016. See November 2016 <strong>CHMP</strong> minutes (to be published post December 2016 <strong>CHMP</strong><br />
meeting).<br />
1.2. Adoption of agenda<br />
<strong>CHMP</strong> agenda <strong>for</strong> 07-10 November 2016<br />
1.3. Adoption of the minutes<br />
<strong>CHMP</strong> minutes <strong>for</strong> 10-13 October2016.<br />
2. Oral Explanations<br />
2.1. Pre-authorisation procedure oral explanations<br />
2.1.1. - pegfilgrastim - EMEA/H/C/004342<br />
treatment of neutropenia<br />
Scope: Oral explanation<br />
Action: Oral explanation to be held on Wednesday 09 November 2016 at time 11:00<br />
List of Outstanding Issues adopted on 13.10.2016, 21.07.2016. List of Questions adopted on<br />
01.04.2016.<br />
2.1.2. - pegfilgrastim - EMEA/H/C/004023<br />
treatment of neutropenia<br />
Scope: Oral explanation<br />
Action: Oral explanation to be held on Wednesday 09 November 2016 at time 11:00<br />
List of Outstanding Issues adopted on 13.10.2016, 21.07.2016. List of Questions adopted on<br />
01.04.2016.<br />
2.1.3. insulin aspart - EMEA/H/C/004046<br />
treatment of diabetes mellitus in adults<br />
<strong>Committee</strong> <strong>for</strong> <strong>medicinal</strong> <strong>products</strong> <strong>for</strong> <strong>human</strong> <strong>use</strong> (<strong>CHMP</strong>)<br />
EMA/<strong>CHMP</strong>/682760/2016 Page 7/30
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