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DI013

Product Details
WHO Product ID
DI013
Status
Prequalified
INN, dosage form and strength
Zinc (sulfate) Tablet, Dispersible 20mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Diarrhoea
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible
Applicant organization
The ACME Laboratories Ltd
Court de la ACME, 1/4,Mirpur Road, Kallayanpur
Dhaka,
1207
Bangladesh
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVDC
Configuration
10x10
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from moisture, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Dr Paul Lohmann GmbH & Co KGaA
Haupstrasse 2
Emmerthal,
D-31860
Germany
Zinc (sulfate)
FPP Manufacturing Site(s)
The ACME Laboratories Ltd
Solid Dosage Unit, Dhulivita, Dhamrai
Dhaka,
1350
Bangladesh
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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