Product class:
|
Authorized package
|
Medicinal product class:
|
For human use
|
Package code:
|
1392218
|
Name of medicinal product:
|
AZARGA
|
Active substances:
|
|
ATC code:
|
S01ED83
|
Dosage form:
|
eye drops, suspension
|
Route of administration:
|
ocular use
|
Strengh:
|
5mg+10mg 1ml
|
Amount in package:
|
5ml 3TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular
hypertension for whom monotherapy provides insufficient IOP reduction.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
Novartis Europharm Limited
|
Marketing authorization number:
|
EU/1/08/482
|
Marketing authorization issued on:
|
November 27, 2008
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
May 2, 2018
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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