Product class: Authorized package
Medicinal product class: For human use
Package code: 1038136
Name of medicinal product: ARTELAC
Active substances:
Estonian, English, Latin
ATC code: S01XA82
Dosage form: eye drops, solution
Route of administration: ocular use
Strengh: 3,2mg 1ml
Amount in package: 10ml 1TK
Legal status for supply*: Not subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Symptomatic treatment of dessication of the cornea and conjunctiva which are caused by disturbed tear secretion due to local or systemic diseases and/or change in the composition of tear fluid, deficient eyelid or incomplete eyelid closure.
Summary of product characteristics (SPC):  (last updated 18 October 2023)
Package information leaflet (PIL): EST  (last updated 18 October 2023)
Translation of package information leaflet into Russian: RUS  (last updated 13 January 2021)
Translation of package information leaflet into English: ENG  (last updated 13 January 2021)
Labelling:  (last updated 18 October 2023)
Last imported to Estonia: 12 June 2024
Marketing authorization holder: Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH 
Marketing authorization number: 269099 
Marketing authorization issued on: 14 June 1999 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 18 October 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription