Euro CPMP Plenary Meeting In October

12 November 1997

At its October plenary meeting, the European Committee for ProprietaryMedicinal Products adopted:

- a positive opinion on a centralized application for a biological/biotechnology product (part A) for active immunization against hepatitis B, diphtheria and tetanus in infants (primary vaccination and booster); - six positive opinions on centralized applications for products containing four new active substances (Part B), indicated for pain relief in skeletal metastases, HIV-1 infection and various bacterial infections; - an opinion on an extension for a centrally-authorized product concerning new formulations; and - two positive opinions for centralized type II variations.

Two scientific advices on clinical development, on cardiovascular indications and the possibility of bridging studies, were adopted by consensus. Three new requests for scientific advice were accepted as justified, and coordinators were appointed.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK





Today's issue

Company Spotlight