Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Uptravi 200 microgram film-coated tablets.
Uptravi 400 microgram film-coated tablets.
Uptravi 600 microgram film-coated tablets.
Uptravi 800 microgram film-coated tablets.
Uptravi 1,000 microgram film-coated tablets.
Uptravi 1,200 microgram film-coated tablets.
Uptravi 1,400 microgram film-coated tablets.
Uptravi 1,600 microgram film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Uptravi 200 microgram film-coated tablets: Round, light-yellow, film-coated tablets with “2” debossed on one side. Uptravi 400 microgram film-coated tablets: Round, red, film-coated tablets with “4” debossed on one side. Uptravi 600 microgram film-coated tablets: Round, light-violet, film-coated tablets with “6” debossed on one side. Uptravi 800 microgram film-coated tablets: Round, green, film-coated tablets with “8” debossed on one side. Uptravi 1,000 microgram film-coated tablets: Round, orange, film-coated tablets with “10” debossed on one side. Uptravi 1,200 microgram film-coated tablets: Round, dark-violet, film-coated tablets with “12” debossed on one side. Uptravi 1,400 microgram film-coated tablets: Round, dark-yellow, film-coated tablets with “14” debossed on one side. Uptravi 1,600 microgram film-coated tablets: Round, brown, film-coated tablets with “16” debossed on one side. |
Uptravi 200 microgram film-coated tablets: Each film-coated tablet contains 200 micrograms of selexipag.
Uptravi 400 microgram film-coated tablets: Each film-coated tablet contains 400 micrograms of selexipag.
Uptravi 600 microgram film-coated tablets: Each film-coated tablet contains 600 micrograms of selexipag.
Uptravi 800 microgram film-coated tablets: Each film-coated tablet contains 800 micrograms of selexipag.
Uptravi 1,000 microgram film-coated tablets: Each film-coated tablet contains 1,000 micrograms of selexipag.
Uptravi 1,200 microgram film-coated tablets: Each film-coated tablet contains 1,200 micrograms of selexipag.
Uptravi 1,400 microgram film-coated tablets: Each film-coated tablet contains 1,400 micrograms of selexipag.
Uptravi 1,600 microgram film-coated tablets: Each film-coated tablet contains 1,600 micrograms of selexipag.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Selexipag |
Selexipag is a selective IP receptor agonist distinct from prostacyclin and its analogues. Selexipag is hydrolysed by carboxylesterases to yield its active metabolite, which is approximately 37-fold more potent than selexipag. Stimulation of the IP receptor by selexipag and the active metabolite leads to vasodilatory as well as anti-proliferative and anti-fibrotic effects. |
| List of Excipients |
|---|
|
Tablet core: Mannitol (E421) Film coating: Uptravi 200 microgram film-coated tablet: Hypromellose Uptravi 400 microgram film-coated tablet: Hypromellose Uptravi 600 microgram film-coated tablet: Hypromellose Uptravi 800 microgram film-coated tablet: Hypromellose Uptravi 1,000 microgram film-coated tablet: Hypromellose Uptravi 1,200 microgram film-coated tablet: Hypromellose Uptravi 1,400 microgram film-coated tablet: Hypromellose Uptravi 1,600 microgram film-coated tablet: Hypromellose |
Polyamide/aluminium/HDPE/PE with an embedded desiccant agent/HDPE blister sealed with an aluminium foil.
Uptravi 200 microgram film-coated tablets: Cartons of 10 or 60 film-coated tablets, and 60 or 140 film-coated tablets (titration packs).
Uptravi 400 microgram, 600 microgram, 800 microgram, 1,000 microgram, 1,200 microgram, 1,400 microgram, and 1,600 microgram film-coated tablets: Cartons of 60 film-coated tablets.
Not all pack sizes may be marketed.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
EU/1/15/1083/001
EU/1/15/1083/002
EU/1/15/1083/003
EU/1/15/1083/004
EU/1/15/1083/005
EU/1/15/1083/006
EU/1/15/1083/007
EU/1/15/1083/008
EU/1/15/1083/009
EU/1/15/1083/010
EU/1/15/1083/011
Date of first authorisation: 12 May 2016
| Drug | Countries | |
|---|---|---|
| UPTRAVI | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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