OLUMIANT Film-coated tablets

Active ingredients: Baricitinib

Product name and form

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.

Qualitative and quantitative composition

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 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:

  • cellulose, microcrystalline
  • croscarmellose sodium
  • magnesium stearate
  • mannitol

Film coating:

  • iron oxide red (E172)
  • lecithin (soya) (E322)
  • macrogol
  • poly (vinyl alcohol)
  • talc
  • titanium dioxide (E171)

Pack sizes and marketing

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.

Marketing authorization holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands

Marketing authorization dates and numbers

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

Drugs

Drug
Countries
Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, Poland, Singapore, United Kingdom, United States, South Africa