Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
IMBRUVICA 140 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule (capsule). White opaque, hard capsule of 22 mm in length, marked with “ibr 140 mg” in black ink. |
Each hard capsule contains 140 mg of ibrutinib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ibrutinib |
Ibrutinib is a potent, small-molecule inhibitor of Bruton’s tyrosine kinase (BTK). BTK, a member of the Tec kinase family, is an important signalling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. Preclinical studies have shown that ibrutinib effectively inhibits malignant B-cell proliferation and survival in vivo as well as cell migration and substrate adhesion in vitro. |
| List of Excipients |
|---|
|
Capsule content: Croscarmellose sodium Capsule shell: Gelatin Printing ink: Shellac |
HDPE bottles with a child-resistant polypropylene closure.
Each carton contains one bottle of either 90 or 120 hard capsules.
Not all pack sizes may be marketed.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
EU/1/14/945/001 (90 hard capsules)
EU/1/14/945/002 (120 hard capsules)
Date of first authorisation: 21 October 2014
Date of latest renewal: 25 June 2019
| Drug | Countries | |
|---|---|---|
| IMBRUVICA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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