Vaccines, Blood & Biologics
Proper Name: Rabies Vaccine
Manufacturer: Sanofi Pasteur, SA, License #1724
- Vaccine for use in all age groups for pre-exposure and post-exposure prophylaxis against rabies.
July 3, 2013 Approval Letter - IMOVAX
To include the update/separate NDC assignments for their carton, vial and diluent labels.
September 14, 2012 Approval Letter - Imovax
STN: BL 103931/5176. Revise the label to include adverse reaction data from post-marketing experience in the Adverse Reactions section,
September 19, 2011 Approval Letter - IMOVAX
STN: BL 103931/5161. Revisions to the carton and syringe diluent labels to change from "Sterile Water for Injection" to "Sterile Water, diluent for reconstitution".
FDA Online Label Repository
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