Joint Programming Initiative

More Years, Better Lives

The Potential and Challenges of Demographic Change

Annual Report on Spontaneous Reporting of Adverse Drug Reactions
Izvješće o nuspojavama

Topic
Health and Performance
Relevance for this Topic
Country Croatia
URL
More Topics

Governance

Contact information

Dr. Viola Macolic-Šarinic / Pharmacovigilance Department
Agency for Medicinal Products and Medical Devices (HALMED)
Ksaverska cesta 4
10000 Zagreb
Croatia
Phone: +38514884100
Fax: +38514884110
Email: halmed(at)halmed.hr
Url: www.almp.hr/.../Izvjesce_o_nuspojavama_u_2012.pdf

Timeliness, transparency

Data is available within one year of collection.

Type of data


Registry

Type of Study


Longitudinal survey. Data colleceted from different sources (health staff, marketing authorisation holders, patients, side effects in clinical trials, etc.)

Data gathering method

Registries


Access to data

Conditions of access


Free access


Up to one year


Aggregated tables


Excel


Data is available in English and Croatian.


Coverage


Data has been collected from 2004 until 2012.


2005


Stratification by county, adverse drug reactions, side effects


Official Statistics


NUTS-1, NUTS-3


All ages


Patients with side effects


The data cover all spontaneous reporting of adverse drug reactions. The data source allows for a detailed study.


• Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2012 - Croatian Document


Linkage


The European Medicines Agency (EMA) and The Heads of Medicines Agencies


A common variable is patient ID.


Data quality


NA


NA


NA


Applicability


Stable and harmonized data source.


  • The information about this dataset was compiled by the author:
  • Marcel Leppee
  • (see Partners)