KEDRAB
STN: 125613
Proper Name: Rabies Immune Globulin (Human)
Tradename: KEDRAB
Manufacturer: Kamada Ltd.
Indication:
- Passive, transient post-exposure prophylaxis of rabies infection, when given immediately after contact with a rabid or possibly rabid animal and in combination with a rabies vaccine.
Product Information
- Package Insert - KEDRAB
- Demographic Subgroup Information - Rabies Immune Globulin (Human)
Refer to Section 1.1 of the clinical reviewer memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- Preclinical Pharm-Tox Review - KEDRAB
- Clinical Review Memo - KEDRAB
- Statistical Review Memo -KEDRAB
- May 17, 2021 Approval Letter - KEDRAB
- August 23, 2017 SBRA - KEDRAB
- August 23, 2017 Approval Letter - KEDRAB
- Approval History, Letters, Reviews, and Related Documents - KEDRAB