Details
Product Name in the RMS: Spironolacton Accord
MR Number: NL/H/3508/002
Date of outcome: 02.12.2015
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Initial Application Generic Chemical Substance Prescription Only |
Active Substances |
spironolactone 50 mg |
Form | Film coated tablet |
MA Holder in the RMS |
Accord Healthcare Ltd Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
RMS | Netherlands |
Date of last change | 29.10.2020 |
ATC-Code |
C03DA01 Spironolactone |
CMS Country | Domestic Product Name |
---|---|
Bulgaria | Spironolacton Accord |
Denmark | |
Estonia | SPIRONOLACTONE ACCORD |
Germany | Spironolacton Accord 50 mg Filmtabletten |
Ireland | |
Latvia | Spironolactone Accord 50 mg apvalkotās tabletes |
Lithuania | Spironolactone Accord 50 mg plėvele dengtos tabletės |
Poland | Ismian |
Slovak Republic | Spironolactone Accord 50 mg filmom obalené tablety |
Sweden | |
United Kingdom |
Documents | |
---|---|
PAR: | NL_H_3508_002_PAR.pdf (28.09.2016) |
PARSummary: | NL_H_3508_002_PARSummary.pdf (28.09.2016) |
FinalSPC: | NL_H_3508_002_FinalSPC.pdf (02.07.2018) |
FinalPL: | NL_H_3508_002_FinalPL.pdf (13.05.2020) |
FinalLabelling: | NL_H_3508_002_FinalLabelling.pdf (02.07.2018) |