Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

EU CHMP Opinions and MAA Updates

Executive Summary

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

You may also be interested in...



BMS’ Cell Therapy For Lymphoma On Track For EU-Wide Approval

Several new drugs are now on track for an EU marketing authorization after getting the EMA’s thumbs up this week. 

Ophthalmic Bevacizumab Sponsor Not Giving Up On EMA Rejection

The European Medicines Agency has been asked to re-examine its rejection of the EU marketing application for Ipique, which, if approved, could become the first drug containing bevacizumab to be authorized for use in neovascular (wet) macular degeneration.

EMA Probe Finds No Link Between GLP-1s And Suicidal Thoughts & Actions

After reviewing the evidence from non-clinical studies, clinical trials, post-marketing surveillance data and other studies, the European Medicines Agency said there was no need to update the product information for 11 diabetes and weight management drugs.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS145609

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel