European Blue List: European Drug Registrations, 1st Edition (Hardback) book cover

European Blue List

European Drug Registrations, 1st Edition

Edited by Karl Feiden

Medpharm

3,160 pages

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Hardback: 9780849300301
pub: 1999-03-01
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Description

Since 1995, the European Commission, on the basis of an opinion prepared by the European Agency for the Evaluation of Medicinal Products (EMEA), has allowed certain medical products to be registered in the European Community under a centralized procedure. These products may then be marketed directly in all member states without additional national registration in individual member states. European Blue List: European Drug Registrations is a compilation of essential parts of the European Public Assessment Reports (EPARs) issued for centrally authorized medicinal products for human and veterinary use. This loose-leaf handbook also contains relevant regulations and directives that constitute the European drug registration system; reports on the evaluation of the drugs; and summaries of product characteristics for medicinal products for human and veterinary use.

Table of Contents

General

Preface

How to Use This Compendium

General Name Index

Introduction

Explanation Concerning the Structure of the Registration Number of Human and Veterinary Medicinal Products in the Centralized Procedure

Brandnames of Medicinal Products

Brandnames of European Registrations (General List of Medicinal Products for Human and Veterinary Products)

Brandnames of Medicinal Products for Human Use

Brandnames of Medicinal Products for Veterinary Use

Active Substances

Active Substances for Human Use

Active Substances for Veterinary Use

Marketing Authorization Holders

Marketing Authorization Holders and Their Products (Medicinal Products for Human Use)

Marketing Authorization Holders and Their Products (Medicinal Products for Veterinary Use)

Chronological Lists of Registrations

Chronological List of Registrations Chronological Lists of Registrations

Chronological List of Registrations (Medicinal Products for Human Use)

Chronological List of Registrations (Medicinal Products for Veterinary Use)

User Package Leaflets for Medicinal Products for Human Use

Summaries of Product Characteristics (SPC) for Medicinal Products for Human Use

Scientific Discussion (Medicinal Products for Veterinary Use)

User Package Leaflets for Medicinal Products for Veterinary Use

Summaries of Product Charaacteristics (SPC) for Medicinal Products for Veterinary Use

Scientific Discussion (Medicinal Products for Veterinary Use)

Legislative Background of the Community Registration System for Medicinal Products

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology