Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium
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’. |
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 Release liner: Transparent fluoropolymer coated polyester film |
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.
UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium
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
| Drug | Countries | |
|---|---|---|
| NEUPRO | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States |
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