Yentreve

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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 21/12/2021

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
28
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

15/12/2021 Yentreve - EMEA/H/C/000545 - N/0072

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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