OLUMIANT Film-coated tablets Ref.[6377]
Active ingredients: Baricitinib

Source: European Medicines Agency (EU) |  Revision Year: 2018 |  Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands

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

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
OLUMIANT
Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States, South Africa
 
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