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Ecotoxicity/environmental risk assessment data for Dificlir

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Dear European Medicines Agency,

In the 2011, Assessment report for Dificlir (http://www.ema.europa.eu/docs/en_GB/docu...)
the following appears in section 2.3.5:

"The applicant has provided timelines for the studies necessary to evaluate the environmental fate and effect of fidaxomicin including timelines for the Phase II Tier A environmental fate and effect analysis and submission of the report."

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents provided by the applicant to-date on the environmental fate and effects of fidaxomicin be made available.

Yours faithfully,

Usman Khan

Agence européenne des médicaments

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Date: Wed, 24 Feb 2016 21:26:39 +0000
From: Usman Khan <[FOI #2631 email]>
To: FOI requests at EMA <[EMA request email]>
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Subject: Freedom of Information request - Ecotoxicity/environmental risk
assessment data for Dificlir
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AskEMA, Agence européenne des médicaments

Dear Sir/Madam

Re: ASK-18821 Access to documents request: Ecotoxicity/environmental risk
assessment data for Dificlir received on 18 March 2016

Thank you for submitting your request.

This is an automated response to confirm that we have received your
request; please do not respond to this message.

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Nous ne savons pas si la réponse la plus récente à cette demande contient l'information ou non – si vous etes Usman Khan veuillez vous connecter et laisser nous savoir.