Search instructions for the SPC
Search instructions for the SPC
General information about searches
The SPCs are published in Finnish; the use of Finnish key words in the search fields is therefore recommended.
Enter a word or part of a word cut off with a * sign (for example tab*) in the search field and click Search or Enter. The search will return all SPCs/PLs where the word or string of characters appears.
If your keyword returns too many documents, refine your search by adding letters or signs to the keyword and searching again.
Selecting a letter lists all SCP or PL documents and links to the EMA: EPAR PI documents for all medicinal products beginning with that letter.
Name of the medicinal product
To search for documents using the Name of the medicinal product field, type the full or partial name of a pharmaceutical preparation into the field. If you are using a partial name, add an asterisk (*) to the end (e.g. tr*).
The ATC code field enables you to search for documents of preparations that belong to a given ATC group. If you are using a partial code, add an asterisk (*) to the end (e.g. D01*).
EMA: EPAR PI links
The SPCs and PLs service provided by Fimea contains links to the EPAR PI documents of medicinal products published by the EMA as part of the centralised procedure.
The links in Fimea's service take you to the Finnish and Swedish language documents on the EMA website.
You can search for EPAR PI documents of drugs in Fimea's service by using the alphabetical list or searching by name of medicinal product or ATC code.
An EPAR PI document published by the EMA contains texts for pharmaceutical forms and strengths of given trade names. The contents of EPAR PI is also divided by subjects as follows: summary of product characteristics, manufacturers responsible for batch release, conditions or restrictions regarding supply and use, other conditions and requirements of the marketing authorization, conditions or restrictions with regard to the safe and effective use of the medicinal product, labeling and package leaflet. EPAR PI document contains clickable bookmarks that take you to a particular section, such as package leaflet.
Searches Based on XML Structures
The search options in the Fimea's service – Marketing authorisation holder, Free text search, Active agent, Pharmaceutical form, Adverse effect, Therapeutic indication and Contraindication – are based on the XML structure of SPC documents submitted to Fimea.
Perfect functionality of searches cannot be guaranteed for SPCs. This is due to issues related to the technical quality of documents submitted to Fimea and the wide range of style conversion options in Microsoft Word that affect the conversion to XML.
Medicinal products belonging to the centralised procedure (EMA's EPAR PI document links) cannot be searched in the Fimea's service using the XML based search options above.
Name of marketing authorisation holder returns all medicinal products for which that company holds marketing authorisation.
Phrase search allows you to search for any individual word, phrase or string of characters appearing in the SPCs.
The combined search function lets you to enter several keywords or parts thereof in e.g. two fields (for example tab* in the Pharmaceutical Form field and tamsulos* in the Qualitative Composition field, in which case the search will return all SPCs where the pharmaceutical form is tablet and the active ingredient is tamsulosin hydrochloride.
If you enter several words separated by spaces or commas, the search will return documents containing all the words. For example, the keywords ADHD children in the Therapeutic Indications field return the SPCs where the words ADHD and children appear under the heading of therapeutic indications. The search is not case-sensitive.
You can search for the name of a pharmaceutical company e.g. with the character string *spira*, which will return all documents with Hospira Enterprises BV as marketing authorisation holder.
If you wish to search for an exact phrase, use quotation marks around the keywords. The phrase idiopathic angioedema in the Contraindications field returns documents where the phrase appears under the heading of contraindications.
Package leaflets can be searched by name of medicinal product, marketing authorisation number or ATC code as described above.
Use the Acrobat search function (Edit -> Find) to search package leaflets in PDF format.
If there are separate SPCs of the product for prescription and over-the-counter use, the letters OTC appear after the name of the SPC of the over-the-counter product, e.g. Beconase Aqua 50 microg dose nasal spray SPC OTC 2004-08-07
The PL link on the left lets you skip to the product's package leaflet.
The symbol appears next to new or updated SPC and package leaflets.
- EMA, European Medicines Agency
- EPAR, European Public Assessment Report
- PI, Product Information
- SPC, Summary of Product Characteristics
- ATC, Anatomical Therapeutic Chemical
- XML, Extensible Markup Language
- OTC, Over The Counter
- PL, Package Leaflet