Ondansetron (as hydrochloride dihydrate)
4mg/2ml Solution for Injection(DEMO SA) HA597

WHOPAR part 1

July 2015

WHO Prequalification Programme
WHO PUBLIC ASSESSMENT REPORT (WHOPAR)ZOPHRALEN 1
International Nonproprietary Name (INN):
Ondansetron (as hydrochloride dihydrate) 4mg/2ml Solution for Injection
Abstract
ZOPHRALEN, manufactured at DEMO SA was submitted to be considered forprequalification in 2013 when the product was licensed / registered in at least one of the ICH
regions and subsequently accepted for the WHO list of prequalified products for the treatmentof HIV/AIDS related conditions on 21 October 2013.
The “Procedure for prequalification of pharmaceutical products 2” defines specific evaluation
mechanisms for products approved by regulatory authorities, which apply similar stringent
standards for quality, safety and efficacy as those required by WHO.
The prequalification of this product by the WHO Prequalification of Medicines Programme(PQP) is based on the approval by a stringent regulatory authority (SRA), namely the Greek
Authority “National Organization for Medicines” (www.eof.gr) in line with the “Guidelineson submission of documentation for prequalification of finished pharmaceutical products
approved by stringent regulatory authorities” 3.
Hence, no assessment of the data underlying this approval has been undertaken within theWHO Prequalification Programme.
Based on the above, this WHOPAR refers to the information available at the approving
stringent regulatory authority in terms of the assessment of the quality, efficacy and safety as
well as steps taken after the prequalification. Detailed information on the SRA-approved useof this product is described in the Summary of Product Characteristics (SmPC), which is acompany authorized English translation of the Greek SmPC and can be found in thisWHOPAR. The most recent authorized Greek product information can be requested from theGreek Medicines Regulatory Agency (www.eof.gr).
Parts 2a, 2b, 3, 4, 5 and 7 of the WHOPAR for ZOPHRALEN are included here.
ZOPHRALEN contains ondansetron (as hydrochloride dihydrate). Its WHO recommended
use is for the management of postoperative chemotherapy and radiotherapy induced nausea
and vomiting in HIV/AIDS patients.
The most frequent adverse events observed during treatment with ondansetron wereheadache, sensation of warmth or flushing, constipation and local intravenous injection sitereactions.
1

Trade names are not prequalified by WHO. This is the National Medicines Regulatory Authority’s(NMRA) responsibility Throughout this WHOPAR the proprietary name is given as an example only2
http://apps.who.int/prequal/info_general/documents/TRS961/TRS961_Annex10.pdf
3
http://apps.who.int/prequal/info_general/documents/TRS986/TRS986_ANNEX-5_SRA-Guide.pdf

Ondansetron (as hydrochloride dihydrate)
4mg/2ml Solution for Injection(DEMO SA) HA597

WHOPAR part 1

July 2015

The most serious adverse effects of ondansetron (as hydrochloride dihydrate) are
hypersensitivity reactions including anaphylaxis, seizures, chest pain and cardiac arrhythmias(including QT interval prolongation, Torsade de pointes, ventricular fibrillations and cardiacarrest).
The efficacy and safety profile of ondansetron is well established based on the extensive
clinical experience in the treatment and the management of postoperative chemotherapy andradiotherapy induced nausea and vomiting.
Summary of Prequalification Status for ZOPHRALEN

Initial Acceptance
Status on PQ list,
i.e. date of listing
Dossier Evaluation

Date
21 Oct 2013

Outcomelisted16 Sept 2013

MR

Date

MR: meets requirements

The table represents the status of relevant completed activities only.

Outcome