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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
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
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EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine
The European Medicines Agency (EMA) has accepted Valneva’s marketing authorisation application (MAA) for its COVID-19 vaccine candidate, VLA2001. ... If Valneva gets the grant from the EC, the centralised marketing authorisation would be valid in all
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CHMP recommends marketing authorisation for AZ’s Evusheld in the EU
AstraZeneca’s Evusheld, a long-acting antibody combination, has received a recommendation for marketing authorisation in the European Union (EU). ... The treatment has also been given a conditional marketing authorisation by the Medicines and
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Global Blood Therapeutics’ treatment for patients with sickle cell disease approved in Europe
With the EC’s approval, Oxybryta has received marketing authorisation in all EU member states, as well as in Iceland, Liechtenstein and Norway. ... GRT has submitted an application to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA)
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Pfizer/BioNTech’s COVID-19 vaccine is 100% effective in adolescents
emergency use authorisation for the vaccine in the US and the conditional marketing authorisation currently in place in the EU.
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J&J’s multiple sclerosis therapy Ponvory moves closer to EU approval
J&J's pharma division Janssen announced today that the CHMP recommends approval of the marketing authorisation for Ponvory (ponesimod), for the treatment of adult patients with relapsing MS (RMS), with ... The EU marketing authorisation application for
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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
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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
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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.
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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.
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