documentation of the Scientific Advice from the CHMP
Susanne Matthes a fait une demande de Accès à l'information à Agence européenne des médicaments
This request has been closed to new correspondence. Contact us if you think it should be reopened.
Dear European Medicines Agency,
Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:
Scientific Advice from the CHMP on 19 March 2008 (EMEA/H/SA/996/2008/PA/II)
In the EMA public assessment report on Defitelio (Defibrotide) manufactured by Gentium (I was very impressed by the scientific accuracy and stringency of the report!), I found the statement that the “applicant received Scientific Advice from the CHMP on 19 March 2008 (EMEA/H/SA/996/2008/PA/II). The Scientific Advice pertained to clinical aspects of the dossier.”
In order to improve our local Guidelines for Trials which are industry co-sonsored, the above mentioned document is of great importance for our Research Institute.
Re: ASK-6403 access to information request - documentation of the
Scientific Advice from the CHMP received on 18 November 2014
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Dear European Medicines Agency,
Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I requested in November 2014 documents which contain the following information:
Scientific Advice from the CHMP on 19 March 2008 (EMEA/H/SA/996/2008/PA/II). Unfortunately, I did not receive a copy of the document yet. may I kindly remind you to provide me with the respective Information.
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