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	17.06.2021
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
PAR:	AT_H_0351_002_PAR.pdf (04.01.2017)
FinalSPC:	AT_H_0351_002_FinalSPC_1of2.pdf (17.06.2021)
FinalSPC:	AT_H_0351_002_FinalSPC_2of2.pdf (17.06.2021)
FinalPL:	AT_H_0351_002_FinalPL_1of2.pdf (17.06.2021)
FinalPL:	AT_H_0351_002_FinalPL_2of2.pdf (17.06.2021)
FinalLabelling:	AT_H_0351_002_FinalLabelling_1of2.pdf (17.06.2021)
FinalLabelling:	AT_H_0351_002_FinalLabelling_2of2.pdf (17.06.2021)
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)