WHO Product ID
AP003
Status
Prequalified
INN, dosage form and strength
Caffeine citrate Solution for Infusion 60 mg/3 mL
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Apnoea
Type
Finished Pharmaceutical Product
Dosage form
Solution for Infusion
Applicant organization
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
Parma,
43122
Italy
Packaging details and storage conditions
Packaging Type
Ampoule; Type I glass
Configuration
3mL solution in 4mL ampoule x 10
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
Siegfried Pharmachemikalien Minden GmbH
Karlstrasse 15-39, 42-44,
Minden,
32423
Germany
FPP Manufacturing Site(s)
Alfasigma S.p.A.
Via Enrico Fermi, 1 65020, Alanno
Pescara,
Italy