KENTERA Transdermal patch Ref.[7925] Active ingredients: Oxybutinin

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Teva B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands

Product name and form

Kentera 3.9 mg/24 hours transdermal patch.

Pharmaceutical Form

Transdermal patch.

The patch is a clear plastic with an adhesive backing, protected by a release liner that is to be removed prior to application.

Qualitative and quantitative composition

Each transdermal patch contains 36 mg of oxybutynin. The area of the patch is 39 cm², releasing a nominal 3.9 mg of oxybutynin per 24 hours.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Oxybutinin

Oxybutynin acts as a competitive antagonist of acetylcholine at post-ganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle.

List of Excipients

Backing film:

Clear polyester/ethylene-vinyl acetate (PET/EVA)

Middle layer:

Triacetin
Acrylic copolymer adhesive solution containing 2-ethylhexyl acrylate, N-vinyl pyrrolidone and hexamethyleneglycol dimethacrylate polymer domains

Release liner:

Siliconised polyester

Pack sizes and marketing

The transdermal patches are individually contained in LDPE/paper laminate sachets and supplied in Patient Calendar Boxes of 2, 8 or 24 patches.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/03/270/001 8 transdermal patches
EU/1/03/270/002 24 transdermal patches
EU/1/03/270/003 2 transdermal patches

Date of first authorisation: 15 June 2004
Date of latest renewal: 30 April 2009

Drugs

Drug Countries
KENTERA Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom

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