Details
Product Name in the RMS: Dulodet 60 mg gastroresistant capsules, hard
MR Number: NL/H/3297/002
Date of outcome: 23.07.2015
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Known Active Substance Additional Strength/Form Generic Chemical Substance Prescription Only |
Active Substances |
duloxetine 30 mg |
Form | Capsule, hard |
MA Holder in the RMS |
Egis Pharmaceuticals PLC H-1106 Budapest Keresztúri út 30-38 HUNGARY |
RMS | Netherlands |
Date of last change | 20.08.2020 |
ATC-Code |
N06AX21 Duloxetine |
CMS Country | Domestic Product Name |
---|---|
Bulgaria | Duloxetin PI Ltd. |
Hungary | DULODET 60 mg gyomornedv-ellenálló kemény kapszula |
Romania | DULODET 60 mg capsule gastrorezistente |
Slovak Republic | Dulodet 30 mg |
Documents | |
---|---|
PAR: | NL_H_3297_002_PAR.pdf (18.01.2017) |
PARSummary: | NL_H_3297_002_PARSummary.pdf (18.01.2017) |
FinalSPC: | NL_H_3297_002_FinalSPC.pdf (13.07.2016) |
FinalPL: | NL_H_3297_002_FinalPL.pdf (13.07.2016) |
FinalLabelling: | NL_H_3297_002_FinalLabelling.pdf (13.07.2016) |
Finalised Product Information: | NL_H_3297_002_FinalPI.pdf (23.07.2015) |