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 discussion3
Part 7 - Steps before Prequalification
Part 8 - Steps following marketing authorisation3
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 the WHOPAR part 1. If not, the documents are included, if necessary, as certified English translation.
3 These parts are 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 part 1.
Overview of WHO Public Assessment Report (WHOPAR)
AP001
WHOPAR
M
Product name
Caffeine citrate
Dosage
10mg/ml - Solution, Oral
Laboratory
Macarthys Laboratories Limited
United Kingdom of Great Britain and Northern Ireland