Product class: Authorized package
Medicinal product class: For human use
Package code: 1722888
Name of medicinal product: SEPTOLETE OMNI LEMON & ELDERFLOWER
Active substances:
Benzydamine+Cetylpyridinium chloride
Estonian, English, Latin
ATC code: R02AA82
Dosage form: lozenge
Route of administration: oropharyngeal use
Strengh: 3mg+1mg
Amount in package: 16TK
Legal status for supply*: Not subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: lemon and elder flower is indicated in adults, adolescents and children over 6 years of age for anti-inflammatory, analgesic and antiseptic treatment of irritations in the throat, mouth and gums, in gingivitis and pharyngitis.
Safety features: No
Summary of product characteristics (SPC):  (last updated 30 June 2023)
Package information leaflet (PIL): EST  (last updated 30 June 2023)
Translation of package information leaflet into Russian: RUS  (last updated 24 July 2018)
Translation of package information leaflet into English: ENG  (last updated 24 July 2018)
Labelling:  (last updated 30 June 2023)
Last imported to Estonia: 20 March 2024
Marketing authorization holder: KRKA, d.d., Novo mesto 
Marketing authorization number: 952817 
Marketing authorization issued on: 11 October 2017 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 21 March 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription