Details

Product Name in the RMS: SEPTABENE EUKALYPTUS

MR Number: CZ/H/0507/001
Date of outcome: 18.06.2015

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 3 mg cetylpyridinium chloride 1 mg
Form	Lozenge
MA Holder in the RMS	Krka, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
RMS	Czech Republic
Date of last change	22.12.2020
ATC-Code	R02AX03 benzydamine

CMS Country	Domestic Product Name
Bulgaria	Septolete Total
Croatia
Estonia	SEPTOLETE OMNI
Finland
Hungary	SEPTOLETE EXTRA 3 mg/1 mg szopogató tabletta
Italy
Latvia	Septabene 3 mg/1 mg sūkājamās tabletes
Lithuania	Septabene 3 mg / 1 mg kietosios pastilės
Malta
Poland	Septolete ultra
Portugal
Romania	Septolete omni 3 mg/1 mg pastile
Slovak Republic	Septolete extra 3 mg/1 mg tvrdé pastilky
Slovenia

Documents
PAR:	CZ_H_0507_001_PAR.pdf (19.11.2015)
Finalised Product Information:	CZ_H_0507_001_FinalPI.pdf (12.10.2020)