Details

Product Name in the RMS: Duloxetin HEXAL 60 mg magensaftresistente Hartkapsel

MR Number: DE/H/4512/002
Date of outcome: 18.12.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Additional Strength/Form Generic Chemical Substance Prescription Only
Active Substances	DULOXETINE HYDROCHLORIDE 67,32 mg
Form	Gastro-resistant capsule, hard
MA Holder in the RMS	Hexal Aktiengesellschaft Industriestr. 25 83607 Holzkirchen Germany
RMS	Germany
Date of last change	14.10.2021
ATC-Code	N06AX21 Duloxetine

CMS Country	Domestic Product Name
Austria	Duloxetin Sandoz 60 mg - magensaftresistente Hartkapseln
Denmark
Hungary	DULOXETIN SANDOZ 60 mg gyomornedv-ellenálló kemény kapszula
Poland	Duloxetine Sandoz
Slovak Republic	Duloxetin Sandoz 60 mg
Slovenia

Documents
PAR:	DE_H_4512_002_PAR.pdf (26.07.2017)
FinalSPC:	DE_H_4512_002_FinalSPC.pdf (11.01.2019)
FinalPL:	DE_H_4512_002_FinalPL.pdf (11.01.2019)
FinalLabelling:	DE_H_4512_002_FinalLabelling.pdf (11.01.2019)
Finalised Product Information:	DE_H_4512_002_FinalPI_1of3.pdf (14.04.2021)
Finalised Product Information:	DE_H_4512_002_FinalPI_2of3.pdf (14.04.2021)
Finalised Product Information:	DE_H_4512_002_FinalPI_3of3.pdf (14.04.2021)