European Union - English - EMA (European Medicines Agency)

clinuvel europe limited - afamelanotide - protoporphyria, erythropoietic - emollients and protectives - prevention of phototoxicity in adult patients with erythropoietic protoporphyria (epp).

Australia - English - Department of Health (Therapeutic Goods Administration)

clinuvel pharmaceuticals ltd - afamelanotide acetate, quantity: 18 mg - implant - excipient ingredients: polyglactin - scenesse is indicated for prevention of phototoxicity in adult patients with erythropoietic protoporphyria (epp)

United States - English - NLM (National Library of Medicine)

clinuvel inc. - afamelanotide (unii: qw68w3j66u) (afamelanotide - unii:qw68w3j66u) - scenesse® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (epp). none.

United States - English - NLM (National Library of Medicine)

csm clinical supplies management europe gmbh - afamelanotide (unii: qw68w3j66u) (afamelanotide - unii:qw68w3j66u) - scenesse® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (epp). none. the safety and effectiveness of scenesse have not been established in pediatric patients. there were 10 subjects 65 years old and over in the clinical studies for epp [see clinical studies (14)]. of the 125 subjects treated with scenesse in these studies, 4 (3%) were 65 years of age and older. clinical studies of scenesse did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Australia - English - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - olive oil; soya oil - injection, intravenous infusion - excipient ingredients: glycerol; sodium hydroxide; ascorbyl palmitate; egg lecithin; sodium oleate; water for injections - parenteral nutrition for adults and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.

Australia - English - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - soya oil; olive oil - injection, intravenous infusion - excipient ingredients: water for injections; egg lecithin; ascorbyl palmitate; sodium hydroxide; glycerol; sodium oleate - parenteral nutrition for adults and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.

Australia - English - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - olive oil; soya oil - injection, intravenous infusion - excipient ingredients: sodium hydroxide; ascorbyl palmitate; egg lecithin; water for injections; sodium oleate; glycerol - parenteral nutrition for adults and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.

Australia - English - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - olive oil; soya oil - injection, intravenous infusion - excipient ingredients: sodium hydroxide; ascorbyl palmitate; egg lecithin; water for injections; glycerol; sodium oleate - parenteral nutrition for adults and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.

Australia - English - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - soya oil; olive oil - injection, intravenous infusion - excipient ingredients: water for injections; egg lecithin; glycerol; sodium hydroxide; sodium oleate; ascorbyl palmitate - parenteral nutrition for adults and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.

Australia - English - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - olive oil; soya oil - injection, intravenous infusion - excipient ingredients: ascorbyl palmitate; water for injections; egg lecithin; sodium oleate; glycerol; sodium hydroxide - parenteral nutrition for adults and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.