Verorab
Published
Product name
Verorab
Active ingredient
Inactivated rabies virus
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Verorab (inactivated rabies virus) was approved for the following therapeutic use:
Verorab is indicated for pre-exposure prophylaxis against rabies.
Verorab is indicated for post-exposure prophylaxis against rabies.
Verorab should be used in accordance with official local recommendations.
How this medicine works
Protection after vaccination is provided by the induction of rabies neutralising antibodies.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Verorab was considered favourable for the therapeutic use approved.
Sponsor