10 November 2017 EMA/CVMP/698682/2017 Committee for Medicinal Products for Veterinary Use
MRL summary opinion 1
Porcine prolactin Porcine species
On 9 November 2017, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted an opinion 2 recommending the inclusion of porcine prolactin in Table 1 (Allowed substances) of the Annex to Commission Regulation (EU) No 37/2010, in accordance with the following table: Pharmaco-
Marker
Animal
logically
residue
species
Porcine
NOT
Porcine
prolactin
APPLICABLE
Target
Other
Therapeutic
tissues
provisions
classification
No MRL
NOT
For oral use in
Agents acting
required
APPLICABLE
newborn piglets
on the
at a dose of up
reproductive
to 0.2 mg
system
MRLs
active substance
/animal. For use in sows at a total dose of up to 5 mg /animal.
1
Summaries of opinion are published without prejudice to the Commission Decision. Applicants may request re-examination of any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to request such re-examination within 15 days of receipt of the opinion 2
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
Feb 15, 2018 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the European Union ... Animal species. MRLs. Target tissues. Other provisions. Therapeutic classification. Paromomycin. Paromomycin All food produc
Mar 15, 2018 - 30 Churchill Place â Canary Wharf â London E14 5EU â United Kingdom. An agency of the European Union ... Animal species. MRLs. Target tissues. Other provisions. Therapeutic classification. Isoflurane. NOT. APPLICABLE. Equidae. No
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.
Sep 20, 2017 - Major changes ... duplicate marketing authorisations and inclusion of a cover letter ... âWhen submitting duplicate marketing authorisation ...
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 ...
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 ...
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 ...
Sep 8, 2016 - 3-year report on Pharmacovigilance activities. Helen Lee, European Commission. â¢. Scanning the horizon for 2016 â 2018. Peter Arlett, EMA.
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.
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 ...
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a desktop news reader. For a list of RSS readers please refer to ...
Windows is either a registered trademark or a trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc.
