Skip to main content

RH104

Product Details
WHO Product ID
RH104
Status
Prequalified
INN, dosage form and strength
Benzathine benzylpenicillin Powder for suspension for injection + Water for Injection Solvent for parenteral use 2,400,000IU + 6 mL
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Powder for suspension for injection + Solvent for parenteral use
Reference authority
Agencia Española de Medicamentos y Productos Sanitorios
Applicant organization
LABORATORIO REIG JOFRE, S.A.
Packaging details and storage conditions
Packaging Type
Glass, vial (Benzathine Benzylpenicillin) + Glass, ampoule (water for injection)
Configuration
1 vial + 1 x 6ml ampoule; 100 vials + 100 x 6ml ampoules
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from moisture, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
North China Pharmaceutical Group Semisyntech Co., Ltd
No. 8 Xingye Street Shijiazhuang Economic & Technical development Zone,
China
Benzathine benzylpenicillin
FPP Manufacturing Site(s)
LABORATORIO REIG JOFRE, S.A.
Gran Capitán, 10
Sant Joan Despi,
Barcelona
08970
Spain
Laboratorio Reig Jofre SA
Jarama, 111, Polígono Industrial de Toledo
Toledo
45007
Spain
WHO Public Assessment Reports


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. 

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

.