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DATA PRESENTATION

Registration and monitoring of side effects

DATABASE

Primary variables


Adverse drug reaction

Autopsy

Batch No.

Information on death

Medicine information

Name of reporter

Patient's age

Patient's CPR No.

Patient's date of birth

Patient's gender

Patient's initials

Previous medication

Product name

Reporter's workplace

 

List of variables not avaliable for download

Introduction

The Danish Medicines Agency's adverse drug reaction database holds information on all suspected adverse reactions reported by healthcare professionals, patients and relatives. The aim of the database is to monitor adverse drug reactions whilst taking account of legislation and research.

The Danish Medicines Agency registers information about adverse reactions in the database merely on suspicion of a link between a product and an adverse reaction. So the information in the database covers real adverse reactions from a drug and random events fx because a patient has taken another drug at the same time.

Data in the database dates back to 1968, where the database was set up. Doctors, dentists and vets are required to report all serious adverse reactions to the Medicines Agency whilst it is voluntary for patients and relatives to do so.

The Danish Medicines Agency is required to notify the European Medicines Agency (EMA) and the authorities in other EU and EEA countries of suspected serious adverse drug reactions. The Medicines Agency and the regulatory authorities in other EU countries report adverse drug reactions to a joint European database at the EMA, which gives us access to the adverse reactions seen in other EU countries.

More details

Type
Health monitoring
Purpose
Administration

Collection Period

Collection Period
Coverage
Nationwide
Population
The population includes reports of suspected adverse drug reactions
Database Categories

Contact information

Data owner
Danish Health Authority
Contact data owner
Islands Brygge 67
2300 København S
Website - data owner
bit.ly/danish-health-authority
Data administrator
Danish Medicines Agency
Contact data administrator
Danish Medicines Agency
T: 44 88 95 95
E: dkma@dkma.dk
Website - data administrator
bit.ly/laegemiddelstyrelsen-registration-and-monitoring