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CV016

Product Details
WHO Product ID
CV016
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
Zhejiang Huahai Pharmaceutical Co. Ltd.
Xunqiao
Linhai,
Zhejiang
317 024
China
Packaging details and storage conditions
Packaging Type
Blister: Alu/PA/Alu/PVC
Configuration
(4 Nirmatrelvir + 2 Ritonavir) x 5
Shelf life (months)
24
Storage conditions
Do not store 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
Ritonavir
Zhejiang Huahai Pharmaceutical Co. Ltd.
Costal Industrial Zone, Duqiao
Linhai,
Zhejiang
317 016
China
Nirmatrelvir
FPP Manufacturing Site(s)
Cipla Limited
Unit 2, Plot A-42 MIDC, Patalganga, Raigad District
Maharashtra
410 220
India
Zhejiang Huahai Pharmaceutical Co. Ltd.
Xunqiao
Linhai,
Zhejiang
317 024
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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