Kentera (previously Oxybutynin Nicobrand)

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oxybutynin

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

Overview

This is a summary of the European public assessment report (EPAR) for Kentera. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Kentera.

This EPAR was last updated on 22/01/2019

Authorisation details

Product details
Name
Kentera (previously Oxybutynin Nicobrand)
Agency product number
EMEA/H/C/000532
Active substance
oxybutynin
International non-proprietary name (INN) or common name
oxybutynin
Therapeutic area (MeSH)
Urinary Incontinence, Urge
Anatomical therapeutic chemical (ATC) code
G04BD04
Publication details
Marketing-authorisation holder
Teva B.V. 
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
15/06/2004
Contact address

Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Product information

22/11/2018 Kentera (previously Oxybutynin Nicobrand) - EMEA/H/C/000532 - T/0049

Contents

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

Pharmacotherapeutic group

UROLOGICALS

Therapeutic indication

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with unstable bladder.

Assessment history

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