Details
Product Name in the RMS: Azelastin-POS nasal spray
MR Number: AT/H/0351/002
Date of outcome: 06.11.2014
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Line Extension Additional Strength/Form Other Chemical Substance Prescription Only |
Active Substances |
azelastine hydrochloride 1 mg/ml |
Form | Nasal spray, solution |
MA Holder in the RMS |
Ursapharm Arzneimittel GmbH Industristrasse 35 66129 Saarbrücken Germany |
RMS | Austria |
Date of last change | 20.08.2020 |
ATC-Code |
R01AC03 Azelastine |
CMS Country | Domestic Product Name |
---|---|
Belgium | Pollival 1 mg/ml solution pour pulvérisation nasale |
Germany | Azelastin-POS 1 mg/ml Nasenspray, Lösung |
Luxembourg | |
Netherlands | |
Poland | Azelastin POS |
Documents | |
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PAR: | AT_H_0351_002_PAR.pdf (04.01.2017) |
FinalSPC: | AT_H_0351_002_FinalSPC.pdf (01.10.2015) |
FinalPL: | AT_H_0351_002_FinalPL.pdf (01.10.2015) |
FinalLabelling: | AT_H_0351_002_FinalLabelling.pdf (01.10.2015) |
Finalised Product Information: | AT_H_0351_002_FinalPI_1of3.pdf (06.11.2014) |
Finalised Product Information: | AT_H_0351_002_FinalPI_2of3.pdf (06.11.2014) |
Finalised Product Information: | AT_H_0351_002_FinalPI_3of3.pdf (06.11.2014) |