Enzepi Withdrawal of the marketing authorisation in the European Union
On 19 July 2017, the European Commission withdrew the marketing authorisation for Enzepi (pancreas powder) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Allergan Pharmaceuticals International Ltd, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. Enzepi was granted marketing authorisation in the EU on 29 June 2016 as an enzyme replacement treatment for exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. The marketing authorisation was initially valid for a 5-year period. There is no impact on patients expected as Enzepi was not commercially available in Europe. The European Public Assessment Report (EPAR) for Enzepi will be updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact
Nov 29, 2017 - The cessation of validity is due to the fact that the marketing authorisation holder, BioPartners GmbH, had not marketed Somatropin Biopartners in the EU since its initial marketing authorisation. In accordance with the provisions of A
May 31, 2016 - that both species are included in the analytical determinations. ... The HMPC considered that, following a review of the available data, a Public.
Jan 1, 2018 - ... has introduced a number of measures via new or revised texts in the human field to promote 3Rs. These requirements are published in Supplement 9.3 and are in force from 01/01/2018. 1 Correction in title of document. 2 Available at h
Feb 28, 2018 - possible in term of clarity, accessibility to the right information and level of ...... Survey responses received from (Co-) Rapporteurs in relation to ...
Feb 16, 2017 - usually apply for oral explanations at CVMP Working Parties and other CVMP ... explanation to the company, and also specifies the number of ...
Feb 28, 2018 - applications runs well at all stages (from pre-submission to validation, via the 1st and 2nd phases of the evaluation to .... Additional aspects to be covered at the meeting could be the sharing of recent EMA ..... Overall, the majorit
Dec 18, 2015 - All Principal Commissioners/ Commissioners of Customs, Central. Excise & Service Tax/ ... Whenever such appeals are covered by a Supreme.
Jan 1, 2017 - Understand the access to EudraVigilance provided via the EudraVigilance Data Analysis. System (EVDAS). ⢠Be familiar with the EVDAS user ...
Jan 1, 2017 - Revised definition and process for emerging safety issues, previously addressed in GVP. Module VI. ⢠Streamlined information on scientific aspects of signal management. ⢠Clarifications on terminology, roles and responsibilities and
Jan 1, 2018 - highlighting recent measures in the veterinary field to promote reduction ... Experimental and Other Scientific Purposes (Council of Europe), tests performed in animals must be carried out in such a ... In the EU, after 1 January 2013,
Jan 1, 2017 - download (*EVPM). ICSR creation. ICSR ... The following illustration shows the report's filters. EV-M5b - EVDAS .... Grouping is a manual activity performed by the Agency to facilitate such analysis. ...... The ICSR is provided in PDF f
The validation period between submission date and start date is usually sixteen calendar days. (**) Comments from PRAC and CHMP members are not made available to Marketing Authorisation Holders. (***) An updated AR is optional and dependent on the co
Reproduction is authorised provided the source is acknowledged. Page 1 / 7. EMA/825017/2015 Rev.1. Human Medicines Evaluation. The timetables in this document may be subject to revision. Marketing authorisation renewal application - ATMP. Assessment
Oct 7, 2016 - Applications by marketing authorisation holders (MAHs). Guidance for ... Issues identified during validation will be notified to the MAH via email.
Page 1 of 1. Page 1 of 1. Statement of CPFinland on the demis of late Comrade Nelson Mandela.pdf. Statement of CPFinland on the demis of late Comrade Nelson Mandela.pdf. Open. Extract. Open with. Sign In. Main menu. Displaying Statement of CPFinland
Jul 25, 2016 - This supports the view that the current approach remains appropriate and ...... 360 analytes during matrix processing). 361. One concept is the ...
Jul 25, 2016 - different combinations of assigned LOQ and MRL for each data set. 89. Guideline on .... Example for the statistical analysis of residue data .
