Product class: Authorized package
Medicinal product class: For human use
Package code: 1034042
Name of medicinal product: BETOPTIC S
Active substances:
Betaxolol
Estonian, English, Latin
ATC code: S01ED02
Dosage form: eye drops, suspension
Route of administration: ocular use
Strengh: 2,5mg 1ml
Amount in package: 5ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Reduction of elevated intraocular pressure in patients with chronic open angle glaucoma and ocular hypertension
Safety features: Yes
Summary of product characteristics (SPC):  (last updated 13 April 2023)
Package information leaflet (PIL): EST  (last updated 17 November 2023)
Labelling:  (last updated 13 April 2023)
Last imported to Estonia: 13 June 2024
Marketing authorization holder: Immedica Pharma AB 
Marketing authorization number: 234398 
Marketing authorization issued on: 11 December 1998 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
100  05/04/2024     Yes  H40-H42  Oftalmoloog  Yes      
100  05/04/2024     Yes      No  until 4 years   
100  05/04/2024     Yes  H40-H42  Oftalmoloog  Yes  until 4 years   
50  05/04/2024     Yes      No      
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 12 March 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription