Register of
Medicinal Products

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 May 10, 2022)
Package information leaflet (PIL): EST  (last updated May 10, 2022)
Labelling:  (last updated May 10, 2022)
Last imported to Estonia: August 29, 2022
Marketing authorization holder: Immedica Pharma AB 
Marketing authorization number: 234398 
Marketing authorization issued on: December 11, 1998 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
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:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: May 10, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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