Details
Product Name in the RMS: Sevelamercarbonat "Synthon"
MR Number: DK/H/1948/001
Date of outcome: 12.03.2014
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Initial Application Other Chemical Substance Prescription Only |
Active Substances |
sevelamer carbonate 800 mg |
Form | Film coated tablet |
MA Holder in the RMS |
Synthon BV Microweg 22 6545 CM, Nijmegen The Netherlands |
RMS | Denmark |
Date of last change | 06.11.2020 |
ATC-Code |
V03AE02 Sevelamer |
CMS Country | Domestic Product Name |
---|---|
Cyprus | Sevelamer Ledpharm 800mg film-coated tablets |
Estonia | Sevelamer Auxilia |
Finland | |
Greece | SEVELAMER/PROTON |
Hungary | Szevelamer-Karbonát Synthon 800 mg ftbl. |
Iceland | |
Latvia | Sevelamer carbonate Synthon 800 mg apvalkotās tabletes |
Lithuania | Sevelamer Synthon 800 mg plėvele dengtos tabletės |
Poland | Sewelameru węglan Synthon |
Documents | |
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PAR: | DK_H_1948_001_PAR_1of2.pdf (11.06.2018) |
PAR: | DK_H_1948_001_PAR_2of2.pdf (11.06.2018) |
FinalSPC: | DK_H_1948_001_FinalSPC.pdf (23.10.2019) |
FinalPL: | DK_H_1948_001_FinalPL.pdf (23.10.2019) |
FinalLabelling: | DK_H_1948_001_FinalLabelling.pdf (12.03.2014) |