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AP002

WHO Product ID
AP002
Status
Prequalified
INN, dosage form and strength
Caffeine citrate Solution for injection 10mg/ml
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Apnoea
Type
Finished Pharmaceutical Product
Dosage form
Solution for injection
Reference authority
Medicines and Healthcare products Regulatory Agency (MHRA)
Applicant organization
Macarthys Laboratories Limited
Bampton Road, Harold Hill, Romford
Essex,
RM3 8UG
United Kingdom of Great Britain and Northern Ireland
Packaging details and storage conditions
Packaging Type
Ampoule, Type 1 glass
Configuration
1ml x 10
Shelf life (months)
36
Storage conditions
Do not store above 30°C. Do not freeze
API Manufacturing Site(s)
By Organization
By Active Ingredient
Siegfried Pharmachemikalien Minden GmbH
Karlstrasse 15-39, 42-44,
Minden,
32423
Germany
Caffeine citrate
FPP Manufacturing Site(s)
Laboratories Sterop
Scheutlaan 46-50, Anderlecht
Brussels,
B-1070
Belgium
Macarthys Laboratories Limited
Bampton Road, Harold Hill, Romford
Essex,
RM3 8UG
United Kingdom of Great Britain and Northern Ireland
WHO Public Assessment Reports


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.

Part 1 , Part 2 , Part 3 , Part 4 , Part 5 , Part 7

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