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GRAZAX
General data
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 July 17, 2023)
Package information leaflet (PIL):
EST
(last updated July 17, 2023)
Labelling:
(last updated July 17, 2023)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
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
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: November 17, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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