Additional product information "Basic Patient Leaflet" - according to the supplier this information is included in the pack when the product is distributed outside of the Swiss market. It should be noted that this information has neither been prequalified nor approved by Swissmedic.
Part 1 - Abstract
Part 2 - All accepted presentations (including photo)
Part 3 – Patient information leaflet, as approved by the reference authority1
Part 4 – Summary of product characteristics, as approved by the reference authority1
Part 5 – Labelling, as approved by the reference authority1
Part 6 – Scientific discussion2
Part 7 - Steps before Prequalification
Part 8 - Steps following marketing authorisation2
The medicine may be authorised for additional or different uses by national medicines regulatory authorities.
1 If the SRA approved PIL, SmPC and/or labelling, or equivalents thereof, are available in English on the reference SRA website, a link is included in WHOPAR part 1. If not, the documents are included, if necessary, as certified English translation.
2 This part is not available for all products prequalified via the abridged route. If a public assessment report is available and contains this information, a weblink is included in WHOPAR part1.