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EMA Product

Kentera (previously Oxybutynin Nicobrand)

Product approved by European Medicines Agency (EU)

Basic Information

Kentera (previously Oxybutynin Nicobrand)

Regulatory Information

EMEA/H/C/000532

Authorised

June 15, 2004

23

April 8, 2025

Company Information

the netherlands

Teva B.V. Swensweg 5 2031 GA Haarlem

Teva Pharma B.V.

Active Substances Detail

Detailed Information

Therapeutic Indication

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

Overview Summary

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.

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