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In this section: Allergenics

ORALAIR

STN: 125471
Proper Name: Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract
Tradename: ORALAIR
Manufacturer: Stallergenes S.A.
Indication:

ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 5 through 65 years of age.

Product Information

Package Insert - ORALAIR

Supporting Documents

November 9, 2018 Summary Basis for Regulatory Action - ORALAIR
November 9, 2018 Approval Letter - ORALAIR
To extend the indication for use in persons 5 - 9 years of age.
November 9, 2018 Clinical Review Memo - ORALAIR
Statistical Review - ORALAIR
Statistical Review - ORALAIR, April 7, 2014
Clinical Review Memo - ORALAIR, March 20, 2014
Supporting Documents older than three years - ORALAIR

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