Proper Name: Short Ragweed Pollen Allergen Extract (Ambrosia artemisiifolia)
Manufacturer: ALK-Abello A/S
- Indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen.
- September 9, 2022 Approval Letter - RAGWITEK
- Statistical Review - RAGWITEK
- Clinical Review Memorandum - RAGWITEK
- April 16, 2021 Approval Letter - RAGWITEK
- June 7, 2019 Approval Letter - RAGWITEK
- March 21, 2017 Approval Letter - RAGWITEK
To include additional non-clinical studies and revised Pregnancy and Lactation Labeling Rule (PLLR) content and format.
- Supporting Documents older than three years - RAGWITEK
- Approval History, Letters, Reviews, and Related Documents - RAGWITEK