EudraPharm
Encyclopedia
EudraPharm is the database of medicinal products authorised in the European Union
, and includes the information contained in the Summary of Product Characteristics
, the patient or user package leaflet and the information shown on the labelling. The EudraPharm database is accessible to the general public and the information thus made available is worded in an appropriate and comprehensible manner.
The EudraPharm database of authorised medicinal products is foreseen in the EU Regulation 726/2004.
EudraPharm contains only details of products that were licensed using the Centralised procedure. Therefore for human medicines, it is only a new interface for information that was and still is available via the EPARs section at the EMEA.
European Union
The European Union is an economic and political union of 27 independent member states which are located primarily in Europe. The EU traces its origins from the European Coal and Steel Community and the European Economic Community , formed by six countries in 1958...
, and includes the information contained in the Summary of Product Characteristics
Summary of Product Characteristics
The Summary of Product Characteristics is a specific document required within the European Commission before any medicinal product is authorized for marketing. This summary is the definitive description of the product both in terms of its properties, chemical, pharmacological and pharmaceutical...
, the patient or user package leaflet and the information shown on the labelling. The EudraPharm database is accessible to the general public and the information thus made available is worded in an appropriate and comprehensible manner.
The EudraPharm database of authorised medicinal products is foreseen in the EU Regulation 726/2004.
EudraPharm contains only details of products that were licensed using the Centralised procedure. Therefore for human medicines, it is only a new interface for information that was and still is available via the EPARs section at the EMEA.
See also
- European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
- EUDRANETEUDRANETEUDRANET, the European Telecommunication Network in Pharmaceuticals , is an IT platform to facilitate the exchange of information between regulatory partners and industry during submission and evaluation of applications...
- EudraCTEudraCTEudraCT is the European Clinical Trials Database of all clinical trials commencing in the European Union from 1 May 2004 onwards...
- EudraGMPEudraGMPEudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice. The EudraGMP system was launched in April 2007, for use by European Medicines Regulators...
- EudraVigilanceEudraVigilanceEudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area .The European...