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 D-83607 Holzkirchen Germany |
RMS | Germany |
Date of last change | 17.12.2020 |
ATC-Code |
N06AX21 Duloxetine |
CMS Country | Domestic Product Name |
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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 | |
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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) |