Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: SEPTOLETE PLUS
Active substances:
Cetylpyridinium chloride+Benzocaine
Estonian, English, Latin
ATC code: R02AA98
Dosage form: lozenge
Strength: 1mg+5mg
Legal status for supply*: Not subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated May 24, 2016)
Package information leaflet (PIL): EST  (last updated May 24, 2016)
Translation of package information leaflet into Russian: RUS  (last updated May 24, 2016)
Translation of package information leaflet into English: ENG  (last updated May 24, 2016)
Labelling:  (last updated December 11, 2019)
Indication: As disinfective and pain relieving remedy in oral and pharyngeal inflammation.
Safety features: No
Marketing authorization holder: KRKA d.d. Novo mesto 
Marketing authorization number: 402902 
Marketing authorization issued on: December 6, 2002 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1091269  SEPTOLETE PLUS  lozenge  1mg +5mg 30TK  OTC      01.03.2016     
1314245  SEPTOLETE PLUS  lozenge  1mg +5mg 18TK  OTC      30.09.2019     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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