Conditional Registration Of A Dengue Vaccine For Use In Malaysians 9 - 45 Years Of Age

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1) Dengvaxia Powder and Solvent for Suspension for Injection

    (Single dose) – MAL16105045ARZ

2) Dengvaxia MD Powder and Solvent for Suspension for Injection

     (Multidose) – MAL16105046ARZ

The Drug Control Authority (DCA) has decided to register Sanofi Pasteur’s dengue vaccine, Dengvaxiaat it’s meetings in Putrajaya on 31st October 2016 and 25th November 2016. Dengvaxia was approved by DCA only for post-registration (Phase IV) study in Malaysia. It is a conditional registration for two (2) years.

The specific registration conditions imposed on Dengvaxia are as follows:

1.    Dengvaxia is approved by DCA only for post-registration (Phase IV) study in Malaysia. This conditional registration is for two years. If the study fails to verify the clinical benefit or are not conducted with due diligence, DCA may withdraw this approval.

2.    Sanofi Pasteur will commit to conduct a joint study with the Ministry of Health (MOH), Malaysia to assess vaccine effectiveness and safety. The study details will be further discussed by both parties.

3.    The post-registration study design, safety monitoring system and other related conditions will be jointly developed by MOH and Sanofi Pasteur.

4.    All vaccinees must bear the cost of vaccination. Subjects that pass study entry screening (e.g. not pregnant nor breastfeeding) and have given informed consent will be enrolled into the study.

5.    During the conduct of this study, any emerging safety signals must be reported to the DCA without delay for further regulatory decisions.

6.    The interim study reports must be promptly submitted to the DCA until the full closure of the study. The final study report must then be submitted to the DCA.

7.    Sanofi Pasteur will commit to support the MOH in the public education programme about the approved indication and concerns of the dengue vaccine.

 

 

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National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
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