Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
RINVOQ 15 mg prolonged-release tablets.
RINVOQ 30 mg prolonged-release tablets.
RINVOQ 45 mg prolonged-release tablets.
| Pharmaceutical Form |
|---|
|
Prolonged-release tablet. RINVOQ 15 mg prolonged-release tablets: Purple 14 × 8 mm, oblong biconvex prolonged-release tablets imprinted on one side with ‘a15’. RINVOQ 30 mg prolonged-release tablets: Red 14 × 8 mm, oblong biconvex prolonged-release tablets imprinted on one side with ‘a30’. RINVOQ 45 mg prolonged-release tablets: Yellow to mottled yellow 14 × 8 mm, oblong biconvex prolonged-release tablets imprinted on one side with ‘a45’. |
RINVOQ 15 mg prolonged-release tablets: Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg of upadacitinib.
RINVOQ 30 mg prolonged-release tablets: Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 30 mg of upadacitinib.
RINVOQ 45 mg prolonged-release tablets: Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 45 mg of upadacitinib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Upadacitinib |
Upadacitinib is a selective and reversible Janus kinase (JAK) inhibitor. In human cellular assays, upadacitinib preferentially inhibits signalling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2. JAK1 is important in inflammatory cytokine signals while JAK2 is important for red blood cell maturation and JAK3 signals play a role in immune surveillance and lymphocyte function. |
| List of Excipients |
|---|
|
Tablet contents: Microcrystalline cellulose Film coating: Poly(vinyl alcohol) |
RINVOQ 15 mg prolonged-release tablets:
Polyvinylchloride/polyethylene/polychlorotrifluoroethylene – aluminium calendar blisters in packs containing 28 or 98 prolonged-release tablets, or multipacks containing 84 (3 packs of 28) prolonged- release tablets.
HDPE bottles with desiccant and polypropylene cap in carton containing 30 prolonged-release tablets.
Pack size: 1 bottle (30 prolonged-release tablets) or 3 bottles (90 prolonged-release tablets).
Not all pack sizes may be marketed.
RINVOQ 30 mg prolonged-release tablets:
Polyvinylchloride/polyethylene/polychlorotrifluoroethylene – aluminium calendar blisters in packs containing 28 or 98 prolonged-release tablets.
HDPE bottles with desiccant and polypropylene cap in carton containing 30 prolonged-release tablets.
Pack size: 1 bottle (30 prolonged-release tablets) or 3 bottles (90 prolonged-release tablets).
Not all pack sizes may be marketed.
RINVOQ 45 mg prolonged-release tablets:
Polyvinylchloride/polyethylene/polychlorotrifluoroethylene – aluminium calendar blisters in packs containing 28 prolonged-release tablets.
HDPE bottles with desiccant and polypropylene cap in carton containing 28 prolonged-release tablets.
Not all pack sizes may be marketed.
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
EU/1/19/1404/001
EU/1/19/1404/002
EU/1/19/1404/003
EU/1/19/1404/004
EU/1/19/1404/005
EU/1/19/1404/006
EU/1/19/1404/007
EU/1/19/1404/008
EU/1/19/1404/009
EU/1/19/1404/010
EU/1/19/1404/011
Date of first authorisation: 16 December 2019
| Drug | Countries | |
|---|---|---|
| RINVOQ | Austria, Australia, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States, South Africa |
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