Details

Product Name in the RMS: Septabene 1.5 mg/ml + 5.0 mg/ml

MR Number: CZ/H/0508/001
Date of outcome: 15.06.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Initial Application Other Chemical Substance Non Prescription (including OTC)
Active Substances	benzydamine hydrochloride 1,5 mg cetylpyridinium chloride 5 mg
Form	Oromucosal spray, solution
MA Holder in the RMS	KRKA d.d., Novo Mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
RMS	Czech Republic
Date of last change	29.12.2020
ATC-Code	R02AX03 benzydamine

CMS Country	Domestic Product Name
Bulgaria	Septolete total
Croatia	Septolete duo 1,5 mg/5 mg u 1 ml sprej za usnu sluznicu, otopina
Estonia	SEPTOLETE OMNI
Hungary	SEPTOLETE EXTRA 1,5 mg/ml + 5 mg/ml szájnyálkahártyán alkalmazott oldatos spray
Ireland
Italy
Latvia	Septabene 1,5 mg/5,0 mg/ml aerosols izsmidzināšanai mutes dobumā, šķīdums
Lithuania	Septabene 1,5 mg / 5 mg / 1 ml burnos gleivinės purškalas (tirpalas)
Poland
Portugal
Romania	Septolete omni 1,5 mg + 5,0 mg/ml spray bucofaringian, soluție
Slovak Republic	Septolete extra 1,5 mg/ml + 5 mg/ml
Slovenia

Documents
PARSummary:	CZ_H_0508_001_PARSummary.pdf (19.11.2015)
Finalised Product Information:	CZ_H_0508_001_FinalPI.pdf (13.11.2020)