Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
Olumiant 2 mg film-coated tablets.
Olumiant 4 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Olumiant 2 mg film-coated tablets: Light pink, 9.0 × 7.5 mm oblong tablets, debossed with “Lilly” on one side and “2” on the other. Olumiant 4 mg film-coated tablets: Medium pink, 8.5 mm round tablets, debossed with “Lilly” on one side and “4” on the other. The tablets contain a recessed area on each side. |
Olumiant 2 mg film-coated tablets: Each film-coated tablet contains 2 mg baricitinib.
Olumiant 4 mg film-coated tablets: Each film-coated tablet contains 4 mg baricitinib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Baricitinib |
Baricitinib is a selective and reversible inhibitor of Janus kinase (JAK)1 and JAK2. In isolated enzyme assays, baricitinib inhibited the activities of JAK1, JAK2, Tyrosine Kinase 2 and JAK3 with IC50 values of 5.9, 5.7, 53 and >400 nM, respectively. Janus kinases (JAKs) are enzymes that transduce intracellular signals from cell surface receptors for a number of cytokines and growth factors involved in haematopoiesis, inflammation and immune function. |
| List of Excipients |
|---|
|
Tablet cores:
Film coating:
|
Polyvinylchloride/polyethylene/polychlorotrifluoroethylene – aluminium blisters in cartons of 14, 28, 35, 56, 84 or 98 film-coated tablets.
Polyvinylchloride/aluminium/oriented polyamide – aluminium perforated unit dose blisters in cartons of 28 × 1 or 84 × 1 film-coated tablets.
Not all pack sizes may be marketed.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
Olumiant 2 mg film-coated tablets:
EU/1/16/1170/001
EU/1/16/1170/002
EU/1/16/1170/003
EU/1/16/1170/004
EU/1/16/1170/005
EU/1/16/1170/006
EU/1/16/1170/007
EU/1/16/1170/008
Olumiant 4 mg film-coated tablets:
EU/1/16/1170/009
EU/1/16/1170/010
EU/1/16/1170/011
EU/1/16/1170/012
EU/1/16/1170/013
EU/1/16/1170/014
EU/1/16/1170/015
EU/1/16/1170/016
Date of first Authorisation: 13 February 2017
| Drug | Countries | |
|---|---|---|
| OLUMIANT | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States, South Africa |
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