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TB384

Product Details
WHO Product ID
TB384
Status
Prequalified
INN, dosage form and strength
Meropenem Powder for solution for injection 1g
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Powder for solution for injection
Reference authority
Medicines and Healthcare products Regulatory Agency (MHRA)
Applicant organization
Venus Pharma GmbH
Am Bahnhof 1-3
Werne,
59368
Germany
Packaging details and storage conditions
Packaging Type
Vial, Glass
Configuration
10 vials x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Shenzhen Haibin Pharmaceutical Co., Ltd
No. 2003, Shenyan Road, Yantian District
China
Meropenem
FPP Manufacturing Site(s)
Venus Remedies Limited
Hill Top Industrial Estate, Jharmajri EPIP, Phase-1 (Extn.), Bhatoli Kalan, Distt. Solan (Himachal Pradesh)
Baddi,
173205
India
WHO Public Assessment Reports


Part 1 - Abstract
Part 2 - All accepted presentations (includign 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 7

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