Details
Product Name in the RMS: Olynth 0.5 mg/ml nasal spray, solution
MR Number: RO/H/0196/001
Date of outcome: 22.07.2014
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Known Active Substance Initial Application Bibliographic Chemical Substance Non Prescription (including OTC) |
Active Substances |
xylometazoline hydrochloride 0,5 mg/ml |
Form | Nasal spray, solution |
MA Holder in the RMS |
McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24 Ireland |
RMS | Romania |
Date of last change | 08.12.2020 |
ATC-Code |
R01AA07 Xylometazoline |
CMS Country | Domestic Product Name |
---|---|
Latvia | |
Poland | Sudafed XyloSpray dla dzieci |
Documents | |
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FinalSPC: | RO_H_0196_001_FinalSPC.pdf (20.11.2019) |
FinalPL: | RO_H_0196_001_FinalPL_1of2.pdf (18.10.2019) |
FinalPL: | RO_H_0196_001_FinalPL_2of2.pdf (18.10.2019) |
FinalLabelling: | RO_H_0196_001_FinalLabelling.pdf (22.07.2014) |
Finalised Product Information: | RO_H_0196_001_FinalPI.pdf (20.11.2019) |