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 01/06/2023

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
21
Date of issue of marketing authorisation valid throughout the European Union
15/06/2004
Contact address

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

Product information

26/05/2023 Kentera (previously Oxybutynin Nicobrand) - EMEA/H/C/000532 - PSUSA/00002253/202207

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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

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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