NEUPRO 1mg/24h, 3mg/24h Transdermal patch Ref.[8291] Active ingredients: Rotigotine

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium

Product name and form

Neupro 1 mg/24 h transdermal patch.

Neupro 3 mg/24 h transdermal patch.

Pharmaceutical Form

Transdermal patch.

Thin, matrix-type, square-shaped with rounded edges, consisting of three layers.

Neupro 1 mg/24 h transdermal patch: The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 1 mg/24 h’.

Neupro 3 mg/24 h transdermal patch: The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 3 mg/24 h’.

Qualitative and quantitative composition

Neupro 1 mg/24 h transdermal patch: Each patch releases 1 mg of rotigotine per 24 hours. Each patch of 5 cm 2 contains 2.25 mg of rotigotine.

Neupro 3 mg/24 h transdermal patch: Each patch releases 3 mg of rotigotine per 24 hours. Each patch of 15 cm 2 contains 6.75 mg of rotigotine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Rotigotine

Rotigotine is a non-ergolinic dopamine agonist for the treatment of signs and symptoms of Parkinson’s disease and Restless Legs Syndrome.

List of Excipients

Backing layer:

Polyester film, siliconized, aluminized, colour coated with a pigment (titanium dioxide (E171), pigment yellow 95, pigment red 166) layer and imprinted (pigment red 144, pigment yellow 95, pigment black 7)

Self adhesive matrix layer:

Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate
Povidone K90
sodium metabisulphite (E223)
ascorbyl palmitate (E304)
DL-α-tocopherol (E307)

Release liner:

Transparent fluoropolymer coated polyester film

Pack sizes and marketing

Peel off sachet in a plastic box: One side is composed of an ethylene copolymer (innermost layer), an aluminium foil, low density polyethylene film and paper; the other side is composed of polyethylene (innermost layer), aluminium, ethylene copolymer and paper.

The box contains 7, 14, 28, 30 or 84 (multipack containing 3 packs of 28) transdermal patches, individually sealed in sachets.

Not all pack sizes may be marketed.

Marketing authorization holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium

Marketing authorization dates and numbers

Neupro 1 mg/24 h transdermal patch:

EU/1/05/331/038
EU/1/05/331/040
EU/1/05/331/041
EU/1/05/331/044
EU/1/05/331/056

Neupro 3 mg/24 h transdermal patch:

EU/1/05/331/047
EU/1/05/331/049
EU/1/05/331/050
EU/1/05/331/053
EU/1/05/331/058

Date of first authorisation: 15 February 2006
Date of latest renewal: 22 January 2016

Drugs

Drug Countries
NEUPRO Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States

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