Please login to the form below

Not currently logged in
Email:
Password:

EU marketing authorisation

This page shows the latest EU marketing authorisation news and features for those working in and with pharma, biotech and healthcare.

Bayer’s Vitrakvi scores first EU tumour-agnostic drug approval

Bayer’s Vitrakvi scores first EU tumour-agnostic drug approval

The European Commission has given Vitrakvi conditional marketing authorisation in the EU for the treatment of adult and paediatric patients with solid tumours that display a NTRK gene fusion, which occurs ... The EU approval is good news for Bayer, as it

Latest news

More from news
Approximately 1 fully matching, plus 55 partially matching documents found.

Latest Intelligence

  • Brexit implications for UK pharma legislation Brexit implications for UK pharma legislation

    require a significant increase in resourcing, met (mostly) by fees for assessing marketing authorisation applications and other services. ... Companies must be established in the EU to hold an EU/EEA marketing authorisation, and exports from the UK would

  • Shoring up the framework Shoring up the framework

    Marketing authorisation holders for medicines, including orphan drugs, must be established in the EU or EEA. ... So for centrally authorised products the marketing authorisation holder will therefore normally need to transfer its marketing authorisation

  • Pharma deals during September 2012 Pharma deals during September 2012

    Biotie will receive additional sales milestones on achievement of undisclosed sales target in Japan, increasing total reward to 89m ($120m). Lundbeck filed a marketing authorisation application for Selincro in the EU

  • Best practice in regulatory outsourcing: top tips Best practice in regulatory outsourcing: top tips

    Holding a national or an EU Marketing Authorisation. Distribution that requires a licence (a Wholesale Dealers Licence and the services of a Responsible Person in the UK). ... Regulatory as a function has, in the past, been seen as the 'police' that says

More from intelligence
Approximately 0 fully matching, plus 4 partially matching documents found.

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
mXm Medical Communications

mXm Medical Communications meets the needs of pharmaceutical marketers and medics who require a highly experienced, bespoke service from their...

Latest intelligence

Happy Chinese New Year 2020 - The Year of The Rat
A fond farewell to The Year of the Pig...
White Paper for download - Explaining the price of your product
In this white paper, he breaks down the pricing options available to you, shares stories from his extensive experiences, and talks you through how to better define your pricing, step-by-step....
OPEN Health expands offering with the launch of a new Learning & Development specialist team
Enhanced expertise to deliver impactful internal training programmes for healthcare clients...

Infographics