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)