Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
AERINAZE
|
Active substances:
|
|
ATC code:
|
R01BA94
|
Dosage form:
|
modified-release tablet
|
Strength:
|
120mg+2,5mg
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Indication:
|
Aerinaze is indicated in adults and adolescents 12 years and older for the symptomatic treatment of
seasonal allergic rhinitis when accompanied by nasal congestion.
|
Safety features:
|
Yes
|
Marketing authorization holder:
|
Organon N.V.
|
Marketing authorization number:
|
EU/1/07/399
|
Marketing authorization issued on:
|
July 30, 2007
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Assessment report:
|
|
Description
|
Additional condition
|
Hambaarstil on õigus välja kirjutada
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1327777
|
AERINAZE
|
modified-release tablet
|
120mg +2,5mg 2TK
|
Prescription
|
|
|
|
|
|
1327788
|
AERINAZE
|
modified-release tablet
|
120mg +2,5mg 4TK
|
Prescription
|
|
|
|
|
|
1327799
|
AERINAZE
|
modified-release tablet
|
120mg +2,5mg 7TK
|
Prescription
|
|
|
|
|
|
1327801
|
AERINAZE
|
modified-release tablet
|
120mg +2,5mg 10TK
|
Prescription
|
|
|
|
|
|
1327812
|
AERINAZE
|
modified-release tablet
|
120mg +2,5mg 14TK
|
Prescription
|
|
|
|
|
|
1327823
|
AERINAZE
|
modified-release tablet
|
120mg +2,5mg 20TK
|
Prescription
|
|
|
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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