Source: European Medicines Agency (EU) Revision Year: 2017 Publisher: Grünenthal GmbH, Zieglerstraße 6, 52078, Aachen, Germany
Qutenza 179 mg cutaneous patch.
| Pharmaceutical Form |
|---|
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Cutaneous patch. Each patch is 14 cm x 20 cm (280 cm²) and consists of an adhesive side containing the active substance and an outer surface backing layer. The adhesive side is covered with a removable, clear, unprinted, diagonally cut, release liner. The outer surface of the backing layer is imprinted with ‘capsaicin 8%’. |
Each 280 cm² cutaneous patch contains a total of 179 mg of capsaicin or 640 micrograms of capsaicin per cm² of patch.
Excipient with known effect: Each 50 g tube of cleansing gel for Qutenza contains 0.2 mg/g butylhydroxyanisole (E320).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Capsaicin |
Capsaicin, or 6-nonenamide, N-[(4-hydroxy-3-methoxyphenyl) methyl]-8-methyl, (6E), is a highly selective agonist for the transient receptor potential vanilloid 1 receptor (TRPV1). The initial effect of capsaicin is the activation of TRPV1-expressing cutaneous nociceptors, which results in pungency and erythema due to the release of vasoactive neuropeptides. |
| List of Excipients |
|---|
|
Patch: Matrix: Silicone adhesives Backing layer: Polyester backing film Removable protective layer: Polyester release liner Cleansing gel: Macrogol 300 |
The Qutenza patch is stored in a paper coated aluminium foil sachet with acrylnitrile-acrylic acid copolymer heat seal layer.
Qutenza is available in a kit containing one or two individually sealed Qutenza patches and a 50 g tube of cleansing gel.
Not all pack sizes may be marketed.
Grünenthal GmbH, Zieglerstraße 6, 52078, Aachen, Germany
EU/1/09/524/001-002
Date of first authorisation: 15 May 2009
Date of latest renewal: 15 May 2014
| Drug | Countries | |
|---|---|---|
| QUTENZA | Austria, Cyprus, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, South Africa |
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