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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 (
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

Agencia Europea de Medicamentos

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    Freedom of Information request Ecotoxicity environmental risk assessment data for Dificlir.txt

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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]>
Message-ID: <[email address]>
Subject: Freedom of Information request - Ecotoxicity/environmental risk
assessment data for Dificlir
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AskEMA, Agencia Europea de Medicamentos

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.

We endeavour to provide a response to all information enquiries (RFI)
within 2 months according to [1]The European Medicines Agency Code of Good
Administrative Behaviour.

Concerning requests for access to documents (ATD), your enquiry will be
processed according to [2]Regulation (EC) No 1049/2001. .
For more information on ATD please refer to our guide on access to
unpublished documents:

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registration for the purpose of the ATD process. Such
acknowledgment/registration will be issued separately following

Should you need to contact us, please always use in the title of your
email, the reference number ASK-18821, which has been allocated to your

Kind regards

European Medicines Agency
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No sabemos si la última respuesta a esta solicitud contiene información o no – si eres Usman Khan por favor abre una sesión y háznoslo saber.