I. Introduction to product submission Submission details Type of submission: New biological entity Decision: Approved Date of decision: 24 February 2017 Date of onto ARTG 7 March 2017 Active ingredient: Phleum pratense Product name: Grazax Sponsor’s name and address: Seqirus Pty Ltd 63 Poplar Rd Parkville Vic 3052 Dose form: Tablet, orally disintegrating Strength: 75,000 SQ-T Container: Blister pack Pack sizes: 10, 30, 90 and 100 tablets Approved therapeutic use: Grazax is indicated for disease modifying treatment of trial pollen (Phleum pratense or allergens cross reacting with P. pratense) induced allergic rhinitis with or without conjunctivitis in adults, adolescents and children above the age 5 years. Route of administration: Oral Dosage: One tablet once daily ARTG number: 267955 Product background This AusPAR describes the application by Seqirus Pty Ltd (the sponsor) to register Grazax standardised allergen extract of grass pollen from Timothy grass (Phleum pratense) 75,000 SQ-T oral lyophilisate tablets for the following indication: Grazax is allergy immunotherapy indicated for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis. Grazax is indicated for disease-modifying treatment of grass pollen induced rhinitis and conjunctivitis. Grazax is approved for use in persons aged 5 years or older.’ Allergy to grass pollen is one of the most common inhalant allergies in the western world. Allergy immunotherapy (AIT) is a treatment option for allergy that is complementary to pharmacotherapy and with a distinct mechanism of action. AIT is performed by repeated
I. Introduction to product submission Submission details Type of submission: New biological entity Decision: Approved Date of decision: 24 February 2017 Date of onto ARTG 7 March 2017 Active ingredient: Phleum pratense Product name: Grazax Sponsor’s name and address: Seqirus Pty Ltd 63 Poplar Rd Parkville Vic 3052 Dose form: Tablet, orally disintegrating Strength: 75,000 SQ-T Container: Blister pack Pack sizes: 10, 30, 90 and 100 tablets Approved therapeutic use: Grazax is indicated for disease modifying treatment of pollen (Phleum pratense or allergens cross reacting with P. pratense) induced allergic rhinitis with or without conjunctivitis in adults, adolescents and children above the age 5 years. Route of administration: Oral Dosage: One tablet once daily ARTG number: 267955 Product background This AusPAR describes the application by Seqirus Pty Ltd (the sponsor) to register Grazax standardised allergen extract of grass pollen from Timothy grass (Phleum pratense) 75,000 SQ-T oral lyophilisate tablets for the following indication: Grazax is allergy immunotherapy indicated for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis. Grazax is indicated for disease-modifying treatment of grass pollen induced rhinitis and conjunctivitis. Grazax is approved for use in persons aged 5 years or older.’ Allergy to grass pollen is one of the most common inhalant allergies in the western world. Allergy immunotherapy (AIT) is a treatment option for allergy that is complementary to pharmacotherapy and with a distinct mechanism of action. AIT is performed by repeated trial