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) |