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