Details

Product Name in the RMS: ACARIZAX

MR Number: DE/H/1947/001
Date of outcome: 30.08.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Initial Application Full Dossier Biological: Other Prescription Only
Active Substances	allergen extract mixture 12 SQ-HDM
Form	Oral lyophilisate
MA Holder in the RMS	ALK-Abelló A/S Boge Allé 6-8. DK-2970 Horsholm Denmark
RMS	Germany
Date of last change	12.01.2021
ATC-Code	V01AA03 house dust mites

CMS Country	Domestic Product Name
Austria	ACARIZAX 12 SQ-HDM Lyophilisat zum Einnehmen
Czech Republic	MITIZAX ®
Denmark	Acarizax
Finland	Acarizax
France
Italy
Norway	Acarizax
Poland	Acarizax
Slovak Republic
Sweden

Documents
PAR:	DE_H_1947_001_PAR.pdf (19.05.2017)
PARSummary:	DE_H_1947_001_PARSummary.pdf (19.05.2017)
FinalSPC:	DE_H_1947_001_FinalSPC.pdf (12.01.2021)
FinalPL:	DE_H_1947_001_FinalPL.pdf (12.01.2021)
FinalLabelling:	DE_H_1947_001_FinalLabelling_1of2.pdf (11.05.2020)
FinalLabelling:	DE_H_1947_001_FinalLabelling_2of2.pdf (11.05.2020)
Finalised Product Information:	DE_H_1947_001_FinalPI.pdf (10.11.2015)