Additional product information "Blue Lady Package Design" - according to the supplier this information has been developed in collaboration with major International Family Planning Organisations for international family projects in developing countries and it is used/included in the pack when the product is distributed in developing countries. It should be noted that this information has neither been prequalified nor approved by the reference stringent regulatory authority (Germany).
Part 1 - Abstract
Part 2 - All accepted presentations (including photo)
Part 3 - WHO-PQ recommended patient information leaflet*
Part 4 - WHO-PQ recommended summary of product characteristics*
Part 5 - Label
Part 6 - Discussion (status at the time of prequalification)
Part 7 - Steps before Prequalification
Part 8 - Steps following Prequalification (from 01 March 2014, only changes to the published information are included)
* This summary of product characteristics/patient information leaflet focus on uses of the medicine covered by WHO Prequalification Team - Medicines. The recommendations for use are based on WHO guidelines and on information from stringent regulatory authorities (term to be revised). The medicine may be authorised for additional or different uses by national medicines regulatory authorities.