Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1314245
Name of medicinal product: SEPTOLETE PLUS
Active substances:
Cetylpyridinium chloride+Benzocaine
Estonian, English, Latin
ATC code: R02AA98
Dosage form: lozenge
Route of administration: oral use
Strengh: 1mg+5mg
Amount in package: 18TK
Legal status for supply*: Not subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: As disinfective and pain relieving remedy in oral and pharyngeal inflammation.
Safety features: No
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)
Last imported to Estonia: September 30, 2019
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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: December 11, 2019
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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