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Wednesday 21 November 2018
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Topic: eu

July 18, 2018
Up to 42% of UK medicines may not be able to market their products in the European Union (EU) post-Brexit, a survey from the European Medicines Agency (EMA) has revealed.

Up to 42% of UK medicines may not be able to market their products in the European Union (EU) post-Brexit, a survey from the European Medicines Agency (EMA) has revealed.
 
The EMA said marketing authorisation holders for 58% of 693 centrally authorised products (CAPs) are on track to ensure they can continue to market their products once the UK leaves the EU in March 2019.
 

June 29, 2017
If approved, it will be indicated for the first-line treatment of adult patients with advanced renal cell carcinoma and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy

EUSA Pharma has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorisation of Fotivda (tivozanib) for the management of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland.

 

February 27, 2017
Truxima is expected to cost less than the reference product and the hope is that these savings could potentially free up budgets for other innovative cancer medications

Mundipharma and its network of independent associated companies will launch Truxima (rituximab) in the UK, Germany, Italy, Netherlands, Belgium, Republic of Ireland and Luxembourg, following authorisation by the EMA.

 

Truxima is the first biosimilar monoclonal antibody authorised by the European Commission (EC) for the treatment of cancers, including diffuse large B-cell lymphoma, follicular lymphoma and chronic lymphocytic leukaemia.1,2

May 16, 2014
Retail pharmacists in France may become the first in Europe to be able to supply patients with biosimilar versions of the biologic drug indicated on the prescription, if new legislation is ratified in that country.

Retail pharmacists in France may become the first in Europe to be able to supply patients with biosimilar versions of the biologic drug indicated on the prescription, if new legislation is ratified in that country.

The move to push the use of cheaper versions of biotech drugs has caused concern in drug companies in Europe’s second-biggest pharmaceutical market behind Germany.

June 1, 2009
Novartis has received a CHMP positive opinion supporting EU approval of Afinitor

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December 16, 2008
Consultation paper opens talks on how to improve healthcare services across the EU

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July 15, 2008
EMEA give marketing approval for Tredaptive in dyslipidemia and primary hypercholesterolemia

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July 1, 2008
Certolizumab pegol filed with EMEA for treatment of rheumatoid arthritis

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June 9, 2008
EGA report identifies patent-related barriers to affordable generic medicines

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June 6, 2008
Germany approves alteplase to treat catheter dysfunction caused by thrombotic occlusion

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June 6, 2008
SpePharm announces national marketing authorisations for Loramyc in Europe

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May 21, 2008
FDA accept application for cSSI treatment as EU process progresses

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May 7, 2008
Innovative Medicines Initiative to fund not-for-profit research

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April 29, 2008
EU extend marketing authorisation for Zevalin

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April 29, 2008
The EU are set to approve HAE treatment, while US authorities issue a rejection

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April 25, 2008
Neupro recommended for approval in Europe for Restless Legs Syndrome

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April 7, 2008
Apotheke Adhoc to publish dossier on the numerous pharmacy cases currently before the European Court of Justice

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April 4, 2008
A collaboration between Austrian and Indian firms brings neutropenia treatment through a phase I trial

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March 10, 2008
Gilead has submitted a marketing authorisation application for aztreonam lysine for nebuliser solution in the EU

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February 13, 2008
Countries should cooperate to cut soaring costs of treating an ageing population prone to cancer, an EU report says

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January 17, 2008
Several top drug firms received "unannounced" visits early yesterday from officials probing alleged anticompetitive behaviour

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November 29, 2007
Former Soviet states had the largest number of new HIV infections last year in the European region, according to an EU report

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November 23, 2007
With the growing threat of counterfeiting, parallel pharmaceutical trade (PPT) represents

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November 20, 2007
The Committee for Medicinal Products for Human Use of the EMEA has recommended the adoption of a new indication for bevacizumab

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