Details
Product Name in the RMS: Desloratadine Sopharma 0.5 mg/ml oral solution
MR Number: LV/H/0123/001
Date of outcome: 12.05.2015
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Known Active Substance Initial Application Generic Chemical Substance Prescription Only |
Active Substances |
desloratadine 0,5 mg/ml |
Form | Oral solution |
MA Holder in the RMS |
SOPHARMA AD 16 Iliensko Shosse Str., Sofia 1220 Bulgaria |
RMS | Latvia |
Date of last change | 05.04.2020 |
ATC-Code |
R06AX27 Desloratadine |
CMS Country | Domestic Product Name |
---|---|
Bulgaria | Desloratadine Sopharma |
Estonia | DESLORATADINE SOPHARMA |
Finland | |
Lithuania | Desloratadine Sopharma 0,5 mg/ml geriamasis tirpalas |
Poland | |
Sweden |
Documents | |
---|---|
PAR: | LV_H_0123_001_PAR.pdf (05.08.2015) |
FinalSPC: | LV_H_0123_001_FinalSPC.pdf (19.01.2018) |
FinalPL: | LV_H_0123_001_FinalPL.pdf (19.01.2018) |
FinalLabelling: | LV_H_0123_001_FinalLabelling_1of3.pdf (06.03.2020) |
FinalLabelling: | LV_H_0123_001_FinalLabelling_2of3.pdf (06.03.2020) |
FinalLabelling: | LV_H_0123_001_FinalLabelling_3of3.pdf (06.03.2020) |
Finalised Product Information: | LV_H_0123_001_FinalPI_1of3.pdf (06.03.2020) |
Finalised Product Information: | LV_H_0123_001_FinalPI_2of3.pdf (06.03.2020) |
Finalised Product Information: | LV_H_0123_001_FinalPI_3of3.pdf (06.03.2020) |