(*) The Agency strongly recommends submitting the application before the published submission deadline. This is to avoid missing the target start date as a result of a technically invalid eCTD submission, in which case the submission is considered void and it needs to be re-despatched. (~) Comments from PRAC members are not made available to Marketing authorisation Holders (MAHs). (#) An updated AR is optional and dependent on the comments received from PRAC members which create the need for the update.
Oct 31, 2017 - as a result of a technically invalid eCTD submission, in which case the submission is considered void and it needs to be re-despatched. (^) The validation period between submission date and start date is generally seventeen calendar da
Mar 8, 2018 - Treatment of uterine fibroids. Haematology. New medicines authorised. ⢠Adynovi (rurioctocog alfa pegol). Treatment and prevention of bleeding in patients with haemophilia A. New information on authorised medicines. ⢠Feraccru (ferr
Jan 26, 2017 - is an antiparasitic medicine that treats the Varroa mite infestation in honey-bee colonies, which is considered to be the most significant parasitic ...
Treatment of cystine crystal deposits in the eye. New information on authorised medicines. Lucentis (ranibizumab) - change in indication. Treatment of visual ...
of any planned responses to the List of Questions for the parent product application). 31 October 2017. 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555. Send a que
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The new EudraVigilance system and the electronic reporting of individual case ... the ISO/ICH E2B(R3) format: hands-on training course - October 2017 ... granted a conditional marketing authorisation on the basis of less complete clinical data ...
Apr 28, 2017 - 2. The United Kingdom will then become a 'third country'. 3. Preparing for the withdrawal is therefore not just a matter for EU and national authorities, but also for private parties. In view of the considerable uncertainties, in parti
May 30, 2017 - Pharmaceutical companies are invited to present their pre-clinical data pertaining to ... patients per year, as many questions about the best use of ALK ... of knowledge and evidence to support the planning and regulatory.
Jan 26, 2017 - is an antiparasitic medicine that treats the Varroa mite infestation in honey-bee colonies, which is considered to be the most significant parasitic ...
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For a list of RSS readers please refer to our RSS guide and follow the instructions .... WEB-RADR workshop report: mobile technologies and social media as.
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PCWP and HCPWP joint meeting - Sept 2016 - meeting documents. ⢠Workshop on identifying opportunities for 'big data' in medicines development and ...
Used for the management of hypovolaemia (low blood volume) caused by acute (sudden) blood loss .... EMA's Business Continuity Plan for Brexit published.
On arriving for your meeting at 30 Churchill Place, please report to reception where you will be issued with an access pass. This pass will allow you to enter our industry lounge, which you are welcome to utilise during your visit. The industry loung
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a ... Withdrawal of applications for new medicines .... fifth annual regulatory conference on optimising the development of advanced therapies to.
Key information for patients, consumers and healthcare professionals. Published monthly by the European Medicines Agency. An agency of the European Union. HUMAN MEDICINES. HIGHLIGHTS. Issue 107. February 2018. This newsletter is addressed primarily t
4 days ago - EMA/CAT/426129/2018. Page 2/17. Table of contents. 1. Introduction. 5. 1.1. Welcome and declarations of interest of members, alternates and ...
