Summary of product characteristics emea








A European database on medicinal products EudraPharm

10/27/2014
09:37 | Author: Molly Young

Summary of product characteristics emea
A European database on medicinal products EudraPharm

It includes the summary of product characteristics, package leaflets and the but the EMEA has recently updated the database by including product information.

The views expressed in this website do not necessarily reflect the official views of the EU institutions. The European Public Health Alliance runs projects which receive financial support from the European Commission.

EMEA/CHMO working group with patients’ organisations, 2006.

This website is powered by open source solutions and runs on a Linux server.

Health and Consumer Intergroup meeting on Information to Patients.

The EudraPharm database is designed to give on-line access to information about all medicinal products for human or veterinary use that have been authorised in the European Union (EU).

However, this database remains could be improved with information that patients would require such as full details of clinical trials or the efficiency of the medicine, side effects assessments, etc.

Among the information provided, citizens have access to information about the formulation, the strength, the therapeutic area, the route of administration and the pharmaceutical form. It includes the summary of product characteristics, package leaflets and the labeling of medicinal products.

An advanced search function and a new site map should also facilitate navigation on the database. At its first stage of development in 2006, the database was only available in English, but the EMEA has recently updated the database by including product information documents in all available EU languages.

Related EPHA articles : Pharmaceutical Direct-to-Consumer Advertising.

This article was updated to include information about new languages. EudraPharm is the name of the public database launched by the European Medicines Agency (EMEA) to facilitate access to information about medicines available in the European Union.

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Amendment of the summaries of product characteristics - Translation

12/26/2014
07:14 | Author: Chloe Allen

Summary of product characteristics emea
Amendment of the summaries of product characteristics - Translation

of the summaries of product characteristics" in English-Portuguese from Reverso Context: OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA.

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EMEA - Summary of the Product Characteristics - Scribd

10/25/2014
05:29 | Author: Nicholas Clark

Summary of product characteristics emea
EMEA - Summary of the Product Characteristics - Scribd

EMEA - Summary of the Product Characteristics - Download as PDF File (.pdf), Text file (.txt) or read online.

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Differences in product information of biopharmaceuticals in the EU

8/24/2014
03:08 | Author: Chloe Allen

Summary of product characteristics emea
Differences in product information of biopharmaceuticals in the EU

The Summary of Product Characteristics (SPC) approved by the European Medicines Agency (EMEA) and the Package Insert (PI) approved by the Food and.

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The conservative approach in the EU may reflect the central position of the SPC in risk management of new pharmaceuticals. The EU SPC contained more detailed instructions to the prescriber, including the positioning of the product with regard to the stage of the disease and to other therapies. The aim was to identify differences in the product information since such information may have an impact on the planning of global clinical development programmes. A typical feature of the US PI was the detailed description of the efficacy and safety result of the pivotal clinical trials. The Summary of Product Characteristics (SPC) approved by the European Medicines Agency (EMEA) and the Package Insert (PI) approved by the Food and Drug Administration (FDA) were examined for 32 biopharmaceutical products. The approach to safety information, notably to contraindications and warnings was more conservative in the EU SPC.

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Product Information Database - Veterinary Medicines Directorate

6/23/2014
01:25 | Author: Molly Young

Summary of product characteristics emea
Product Information Database - Veterinary Medicines Directorate

Please note, following a change to the terms of a marketing authorisation (MA), the Summary of Product Characteristics (SPC) will be updated and published.

These were last updated on: 22/10/2014 09:31:24. The links below provide a snapshot of the Product Information Database data available for download.

Search Frequently asked questions Help to search Report a problem. Navigate through the tabs to see suspended, expired and homeopathic products. Use the A-Z listings to find a veterinary medicine authorised in the UK, more product details can be found in the associated documents.

The VMD is an executive agency of defra.

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