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CV026

WHO Product ID
CV026
Status
Prequalified
INN, dosage form and strength
Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Covid-19
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated + Tablet, Film-coated
Applicant organization
Shanghai Desano Bio-Pharmaceutical Co., Ltd.
1479 Zhangheng Road, China (Shanghai) Pilot Free Trade Zone
Shanghai
201203
China
Packaging details and storage conditions
Packaging Type
Blister; Alu/OPA/PVC/Alu
Configuration
(4 Nirmatrelvir tablets + 2 Ritonavir tablets) x 5
Shelf life (months)
24
Storage conditions
Do not store above 30°C, avoid excursions above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Shanghai Desano Chemical Pharmaceutical Co., Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Nirmatrelvir, Ritonavir
FPP Manufacturing Site(s)
Shanghai Desano Bio-Pharmaceutical Co., Ltd.
1479 Zhangheng Road, China (Shanghai) Pilot Free Trade Zone
Shanghai
201203
China
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 6 , Part 7 , Part 8

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