Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: GRAZAX
Active substances:
Grass pollen allergen extract
Estonian, English, Latin
ATC code: V01AA02
Dosage form: sublingual lyophilisate
Strength: 75000SQ-T
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated July 17, 2023)
Package information leaflet (PIL): EST  (last updated July 17, 2023)
Labelling:  (last updated July 17, 2023)
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
Marketing authorization holder: ALK-Abello A/S 
Marketing authorization number: 1039221 
Marketing authorization issued on: September 15, 2021 
Marketing authorization expires on: September 15, 2026 
Marketing authorization procedure type: Mutual recognition 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1233885  GRAZAX  sublingual lyophilisate  75000SQ-T 100SQ-T 1TK  Prescription           
1233908  GRAZAX  sublingual lyophilisate  75000SQ-T 30SQ-T 1TK  Prescription      30.12.2009     
1298684  GRAZAX  sublingual lyophilisate  75000SQ-T 90SQ-T 1TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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