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 60 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	12.02.2019
ATC-Code	N06AX21 Duloxetine

CMS Country	Domestic Product Name
Bulgaria	Duloxetin PI Ltd.
Hungary
Poland	Duloxetine Pharmascience International Ltd
Romania	DULODET
Slovak Republic	Dulodet 60 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)