Details
Product Name in the RMS: Ketilept Retard
MR Number: HU/H/0579/005
Date of outcome: 11.11.2014
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Additional Strength/Form Generic Chemical Substance Prescription Only |
Active Substances |
quetiapine 400 mg |
Form | Prolonged release tablet |
MA Holder in the RMS |
EGIS Pharmaceuticals PLC Kereszturi Ut 30-38 Budapest 1106 Hungary |
RMS | Hungary |
Date of last change | 20.08.2020 |
ATC-Code |
N05AH04 Quetiapine |
CMS Country | Domestic Product Name |
---|---|
Bulgaria | Ketilept Retard |
Czech Republic | Libreq 400 mg |
Poland | Ketilept Retard |
Romania | Ketilept EP 400 mg comprimate cu eliberare prelungită |
Slovak Republic | Ketilept Prolong 400 mg tablety s predĺženým uvoľňovaním |
Documents | |
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PAR: | HU_H_0579_005_PAR.pdf (25.01.2018) |
PARSummary: | HU_H_0579_005_PARSummary.pdf (26.01.2016) |
FinalSPC: | HU_H_0579_005_FinalSPC.pdf (02.03.2015) |
FinalPL: | HU_H_0579_005_FinalPL.pdf (02.03.2015) |
FinalLabelling: | HU_H_0579_005_FinalLabelling.pdf (02.03.2015) |