Medicinal Products Database
A medicinal product (under Art. 3 of the Medicinal Products Act, Official Gazette No. 76/13) is any substance or combination of substances intended for treating or preventing disease in human beings; or any substance or combination of substances which may be for human use either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
The substance from this Article may be:
- of human origin, e.g. human blood and human blood derivatives;
- of animal origin, e.g. microorganisms, animals, parts of organs, animal secretions, toxins, extracts, blood products;
- of vegetable origin, e.g. microorganisms, plants, parts of plants, plant secretions, extracts of vegetable matter;
- a chemical element, natural chemical substance and a chemical product obtained by chemical reaction.
In the Republic of Croatia only medicinal products with marketing authorisation granted by either the Agency for Medicinal Products (HALMED) or European Commission may be on the market.
The medicinal product database contains all medicinal products having marketing authorisation granted by HALMED as well as information about medicines authorised by the European Commission based on the scientific assessment by the European Medicines Agency (EMA). Those are centrally authorised medicinal products with authorisation valid in all EU Members States. More information about the centrally authorised medicinal products is available on the EMA web pages in the Find medicine/Human medicine section, or here.
Summaries of product characteristics (SmPC)The Summary of Product Characteristics is a scientific information about the finished medicinal product approved in the marketing authorisation procedure for healthcare professionals. It is used as a source for preparation of package leaflet for the end user and for labelling of the product. and package leaflets (PL)The package leaflet is a written information, containing details for users, inserted in the package of the product and it must be harmonised with the data contained in the Summary of Product Characteristics. are available for all medicines in the database.
For every centrally authorised product the indicated documents are on the "Product information" card.
The medicinal product database may be searched according to the one or more criteria displayed in the Search engine. If your search condition is not a certain medicine, but you would rather find medicinal products with the same or similar name, same active substance, ATC group or the same marketing authorisation holder etc., it is recommended that the medicinal product name, active substance or ATC be used as a search criteria, because centrally authorised products will also be encompassed by the search.
Search results can be exported into an Excel table (.xls file).
Information on medicinal products in the database is available in Croatian.
Information on newly authorised medicinal products is published monthly under News section.
For additional queries please contact us following the link Enquiries.
List of withdrawn/revoked marketing authorisations
Pursuant to the Article 58 of the Medicinal Products Act (Official Gazette, No. 76/13), HALMED publishes on its website the lists of medicinal products with withdrawn/revoked marketing authorisation. Lists include the information on medicinal products in respect of which the marketing authorisations have been withdrawn/revoked since 2009 and are available in tables under the link in the continuation of this text. Lists will be updated once a month for the current year. Currently, the database does not provide the information on the medicinal products in respect of which the marketing authorisations were withdrawn/revoked before 2013.
- List of marketing authorisations withdrawn/revoked in 2016
- List of marketing authorisations withdrawn/revoked in 2015
- List of marketing authorisations withdrawn/revoked in 2014
- List of marketing authorisations withdrawn/revoked in 2013
- List of marketing authorisations withdrawn/revoked in 2012
- List of marketing authorisations withdrawn/revoked in 2011
- List of marketing authorisations withdrawn/revoked in 2010
- List of marketing authorisations withdrawn/revoked in 2009
The Croatian Institute for Toxicology and Anti-Doping (CITA) publishes on its webpages a list of medicinal products authorised in the Republic of Croatia containing any substance from the list of forbidden substances published by the World Anti-Doping Agency (WADA). The CITA webpage with this list is accessible by ckicking on the following link: Antidoping-CITA.