Details

Product Name in the RMS: Dulsevia 60 mg hard gastro-resistant capsules

MR Number: SK/H/0155/002
Date of outcome: 27.03.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	duloxetine 60 mg
Form	Gastro-resistant capsule, hard
MA Holder in the RMS	Krka, d.d., Novo mesto Šmarješka cesta 6 8501 Novo meto, Slovenia
RMS	Slovak Republic
Date of last change	21.04.2021
ATC-Code	N06AX21 Duloxetine

CMS Country	Domestic Product Name
Bulgaria	Dulsevia
Croatia	Dulsevia 60 mg tvrde želučanootporne kapsule
Cyprus	DULOXENTA 60MG HARD GASTRO-RESISTANT CAPS
Czech Republic	Duloxenta 60 mg
Estonia	DULSEVIA
Greece	DULOXENTA
Hungary
Latvia	Dulsevia 60 mg zarnās šķīstošās cietās kapsulas
Lithuania	Dulsevia 60 mg skrandyje neirios kietosios kapsulės
Poland	Dulsevia
Romania	DULSEVIA 60 mg capsule gastrorezistente
Slovenia

Documents
Finalised Product Information:	SK_H_0155_002_FinalPI_1of2.pdf (28.03.2021)
Finalised Product Information:	SK_H_0155_002_FinalPI_2of2.pdf (28.03.2021)