Yentreve

RSS

duloxetine

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 12/04/2019

Authorisation details

Product details
Name
Yentreve
Agency product number
EMEA/H/C/000545
Active substance
duloxetine hydrochloride
International non-proprietary name (INN) or common name
duloxetine
Therapeutic area (MeSH)
Urinary Incontinence, Stress
Anatomical therapeutic chemical (ATC) code
N06AX21
Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
11/08/2004
Contact address
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Product information

18/01/2019 Yentreve - EMEA/H/C/000545 - IG/1055

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Psychoanaleptics

Therapeutic indication

Yentreve is indicated for women for the treatment of moderate to severe stress urinary incontinence (SUI).

Assessment history

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