Details
Product Name in the RMS: Septolux
MR Number: PL/H/0211/001
Date of outcome: 11.02.2015
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Initial Application Other Chemical Substance Non Prescription (including OTC) |
Active Substances |
benzydamine hydrochloride 1,5 mg/ml |
Form | Oromucosal spray, solution |
MA Holder in the RMS |
PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c 170 00 Prague 7 Czech Republic |
RMS | Poland |
Date of last change | 17.11.2020 |
ATC-Code |
A01AD02 Benzydamine |
CMS Country | Domestic Product Name |
---|---|
Hungary | FARINGOSTOP 1,5 mg/ml szájnyálkahártyán alkalmazott oldatos spray |
Slovak Republic | Garganta 1,5 mg/ml |
Documents | |
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PAR: | PL_H_0211_001_PAR_1of2.pdf (15.09.2016) |
PAR: | PL_H_0211_001_PAR_2of2.pdf (15.09.2016) |
FinalSPC: | PL_H_0211_001_FinalSPC.pdf (19.02.2015) |
FinalPL: | PL_H_0211_001_FinalPL.pdf (19.02.2015) |
FinalLabelling: | PL_H_0211_001_FinalLabelling_1of2.pdf (19.02.2015) |
FinalLabelling: | PL_H_0211_001_FinalLabelling_2of2.pdf (19.02.2015) |