Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1392207
Name of medicinal product: AZARGA
Active substances:
Timolol+Brinzolamide
Estonian, English, Latin
ATC code: S01ED83
Dosage form: eye drops, suspension
Route of administration: ocular use
Strengh: 5mg+10mg 1ml
Amount in package: 5ml 1TK
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: September 22, 2022
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 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
50  01.10.2022     Yes      No      
100  01.10.2022     Yes  H40-H42  Oftalmoloog  Yes      
100  01.10.2022     Yes  H40-H42  Oftalmoloog  Yes  until 4 years   
100  01.10.2022     Yes      No  until 4 years   
Reference price: 8,50 EUR 
Under reference price: No 
Reference price of daily dose: 0,17 EUR 
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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