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.

Roche’s Polivy receives EC approval for lymphoma therapy

Roche’s Polivy receives EC approval for lymphoma therapy

for people in the EU diagnosed with this aggressive lymphoma, giving them a greater opportunity for positive outcomes.”. ... In the EU, Polivy's initial conditional marketing authorisation has been given full approval by the European Commission.

Latest news

More from news
Approximately 1 fully matching, plus 61 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

    Lundbeck filed a marketing authorisation application for Selincro in the EU with European Medicines Agency and a decision is expected later this year.

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

    Activities requiring an EU presence include:. Holding a national or an EU Marketing Authorisation. ... Regulatory as a function has, in the past, been seen as the 'police' that says “no” to commercial and marketing plans.

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

Subscribe to our email news alerts

Featured jobs

PMHub

Add my company
Say Communications

Influencing positive behaviours and delivering change is what drives us, using thought leadership, education, social and professional engagement and compelling,...

Latest intelligence

Our Top 5 Pharma Picks From Cannes Lions
Here are five of Art's top five pharma and healthcare picks from Cannes Lions 2022....
The Evolving Role of the Sales Rep
The COVID-19 pandemic sparked an evolution in physician engagement. Jill Padgett, EdD, Head of Training, explores what this means for the sales force and shares her advice for succeeding in...
Measure your omnichannel maturity with our new tool
Try our Omnichannel Maturity Tool to gain tangible advice and an instant analysis of your omnichannel readiness....