Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: CLINUVEL EUROPE LIMITED, 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
SCENESSE 16 mg implant.
| Pharmaceutical Form |
|---|
|
Implant. Solid white to off-white rod approximately 1.7 cm in length and 1.5 mm in diameter |
The implant contains 16 mg of afamelanotide.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Afamelanotide |
Afamelanotide is a synthetic tridecapeptide and a structural analogue of α-melanocyte stimulating hormone (α-MSH). Afamelanotide is a melanocortin receptor agonist and binds predominantly to the melanocortin-1 receptor (MC1R). Afamelanotide is thought to mimic the endogenous compound’s pharmacological activity by activating the synthesis of eumelanin mediated by the MC1R receptor. Eumelanin contributes to photoprotection through different mechanisms. |
| List of Excipients |
|---|
|
Poly (DL-lactide-co-glycolide) |
Type I amber glass vial sealed with a PTFE coated rubber stopper.
Pack of one vial containing one implant.
CLINUVEL EUROPE LIMITED, 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
EU/1/14/969/001
Date of first authorisation: 22 December 2014
Date of latest renewal: 19 November 2019
| Drug | Countries | |
|---|---|---|
| SCENESSE | Austria, Estonia, Finland, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, United Kingdom, United States |
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