Product class: Authorized package
Medicinal product class: For human use
Package code: 1233885
Name of medicinal product: GRAZAX
Active substances:
Grass pollen allergen extract
Estonian, English, Latin
ATC code: V01AA02
Dosage form: sublingual lyophilisate
Route of administration: oromucosal use
Strengh: 75000SQ-T
Amount in package: 100SQ-T 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Disease-modifying treatment of grass pollen induced rhinitis and conjunctivitis in adults and children (5 years or older), with clinically relevant symptoms and diagnosed with a positive skin prick test and/or specific IgE test to grass pollen.
Safety features: No
Summary of product characteristics (SPC):  (last updated 17 July 2023)
Package information leaflet (PIL): EST  (last updated 17 July 2023)
Labelling:  (last updated 17 July 2023)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: ALK-Abello A/S 
Marketing authorization number: 1039221 
Marketing authorization issued on: 15 September 2021 
Marketing authorization expires on: 15 September 2026 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 17 November 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription