Summaries of Product Characteristics (SPC)

With effect from June 1999, summaries of product characteristics for all authorised medicinal products in Denmark are accessible on the Danish Medicines Agency’s home page. The purpose of this is to give citizens and companies easy and quick access to basic information on the medicinal products that are authorised for use in Denmark.

The summaries of product characteristics on the Internet are updated once a week with authorised changes etc.

• Search for summaries of product characteristics (in danish only)
• Guidance for finding summaries of product characteristics for centrally authorised medicinal products

What does the summary of product characteristics contain?

The summary of product characteristics contains a description of a certain medicinal product’s properties and the conditions attached to its use. The document, which is authorised by the Danish Medicines Agency, thus provides information on, for example, the following:

• Name
• Composition (declaration)
• Pharmaceutical form and strength
• Authorised applications (indications)
• Adverse reactions
• Cautions and safety regulations
• Shelf-life
• Storage conditions
• Holder of marketing authorisation (firm)

The summary of product characteristics is prepared for the use of "professional people" and contains a certain amount of professional language. The user is therefore advised to seek information either in the package leaflets that are enclosed in the individual product, from his/her own general practitioner or at the pharmacy.

Which medicinal products are described?

Not all authorised medicinal products are accessible on the market as some firms choose not to market their preparations, even though they have received an authorisation. Information on the medicinal products marketed in Denmark can be found under " Medicine prices" ("Lægemiddelpriser"), which also states consumer prices for all packages. This information is updated every 14^th day.

Formulas for summaries of product characteristics

On the Danish version of the homepage there are two Word 97 forms, which firms can use for both human and veterinary medicinal products. The forms can be downloaded, copied and used to fill out a rough draft, which should then be forwarded to the Danish Medicines Agency together with applications for amendmends etc.

Copying

There is no copyright on the summaries of product characteristics. These can therefore be copied freely onto your own computer.

Additional information

If additional information on summaries of product characteristics is requested, enquiries can be made to Birgit Jensen bj@dkma.dk or Jonas Jensen joj@dkma.dk.