STN: 125478
Proper Name: Short Ragweed Pollen Allergen Extract (Ambrosia artemisiifolia)
Tradename: RAGWITEK
Manufacturer: ALK-Abello A/S, Horshlom Denmark
Indication:

• Ragwitek is an allergen extract 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 for use in persons 5 through 65 years of age.

Product Information

• Package Insert - RAGWITEK
• Medication Guide - RAGWITEK

Supporting Documents

• 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