Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: SEPTOLETE OMNI LEMON & ELDERFLOWER
Active substances:
Benzydamine+Cetylpyridinium chloride
Estonian, English, Latin
ATC code: R02AA82
Dosage form: lozenge
Strength: 3mg+1mg
Legal status for supply*: Not subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated June 30, 2023)
Package information leaflet (PIL): EST  (last updated June 30, 2023)
Translation of package information leaflet into Russian: RUS  (last updated July 24, 2018)
Translation of package information leaflet into English: ENG  (last updated July 24, 2018)
Labelling:  (last updated June 30, 2023)
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
Marketing authorization holder: KRKA, d.d., Novo mesto 
Marketing authorization number: 952817 
Marketing authorization issued on: October 11, 2017 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Assessment report:  (last updated October 11, 2017) 
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1722877  SEPTOLETE OMNI LEMON & ELDERFLOWER  lozenge  3mg +1mg 8TK  OTC           
1722888  SEPTOLETE OMNI LEMON & ELDERFLOWER  lozenge  3mg +1mg 16TK  OTC      20.03.2024     
1722899  SEPTOLETE OMNI LEMON & ELDERFLOWER  lozenge  3mg +1mg 24TK  OTC           
1722901  SEPTOLETE OMNI LEMON & ELDERFLOWER  lozenge  3mg +1mg 32TK  OTC           
1722912  SEPTOLETE OMNI LEMON & ELDERFLOWER  lozenge  3mg +1mg 40TK  OTC           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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