UPTRAVI Film-coated tablet Ref.[8623] Active ingredients: Selexipag

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Product name and form

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.

Qualitative and quantitative composition

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)
Maize starch
Low substituted hydroxypropyl cellulose
Hydroxypropyl cellulose
Magnesium stearate

Film coating:

Uptravi 200 microgram film-coated tablet:

Hypromellose
Propylene glycol
Titanium dioxide (E171)
Iron oxide yellow (E172)
Carnauba wax

Uptravi 400 microgram film-coated tablet:

Hypromellose
Propylene glycol
Titanium dioxide (E171)
Iron oxide red (E172)
Carnauba wax

Uptravi 600 microgram film-coated tablet:

Hypromellose
Propylene glycol
Titanium dioxide (E171)
Iron oxide red (E172)
Iron oxide black (E172)
Carnauba wax

Uptravi 800 microgram film-coated tablet:

Hypromellose
Propylene glycol
Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide black (E172)
Carnauba wax

Uptravi 1,000 microgram film-coated tablet:

Hypromellose
Propylene glycol
Titanium dioxide (E171)
Iron oxide red (E172)
Iron oxide yellow (E172)
Carnauba wax

Uptravi 1,200 microgram film-coated tablet:

Hypromellose
Propylene glycol
Titanium dioxide (E171)
Iron oxide black (E172)
Iron oxide red (E172)
Carnauba wax

Uptravi 1,400 microgram film-coated tablet:

Hypromellose
Propylene glycol
Titanium dioxide (E171)
Iron oxide yellow (E172)
Carnauba wax

Uptravi 1,600 microgram film-coated tablet:

Hypromellose
Propylene glycol
Titanium dioxide (E171)
Iron oxide black (E172)
Iron oxide red (E172)
Iron oxide yellow (E172)
Carnauba wax

Pack sizes and marketing

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.

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Marketing authorization dates and numbers

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

Drugs

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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