Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Incyte Biosciences Distribution B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Netherlands
Iclusig 15 mg film-coated tablets.
Iclusig 30 mg film-coated tablets.
Iclusig 45 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Iclusig 15 mg film-coated tablets: White, biconvex, round film-coated tablet that is approximately 6 mm in diameter, with “A5” debossed on one side. Iclusig 30 mg film-coated tablets: White, biconvex, round film-coated tablet that is approximately 8 mm in diameter, with “C7” debossed on one side. Iclusig 45 mg film-coated tablets: White, biconvex, round film-coated tablet that is approximately 9 mm in diameter, with “AP4” debossed on one side. |
Iclusig 15 mg film-coated tablets: Each film-coated tablet contains 15 mg of ponatinib (as hydrochloride).
Excipients with known effect: Each film-coated tablet contains 40 mg of lactose monohydrate.
Iclusig 30 mg film-coated tablets: Each film-coated tablet contains 30 mg of ponatinib (as hydrochloride).
Excipients with known effect: Each film-coated tablet contains 80 mg of lactose monohydrate.
Iclusig 45 mg film-coated tablets: Each film-coated tablet contains 45 mg of ponatinib (as hydrochloride).
Excipients with known effect: Each film-coated tablet contains 120 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ponatinib |
Ponatinib is a potent pan BCR-ABL inhibitor with structural elements, including a carbon-carbon triple-bond, that enable high affinity binding to native BCR-ABL and mutant forms of the ABL kinase. Ponatinib inhibits the tyrosine kinase activity of ABL and T315I mutant ABL with IC50 values of 0.4 and 2.0 nM, respectively. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Tablet coating: Talc |
Iclusig 15 mg film-coated tablets: High density polyethylene (HDPE) bottles with screw-top closures, containing either 30, 60 or 180 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.
Iclusig 30 mg film-coated tablets: High density polyethylene (HDPE) bottles with screw-top closures, containing 30 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.
Iclusig 45 mg film-coated tablets: High density polyethylene (HDPE) bottles with screw-top closures, containing either 30 or 90 film-coated tablets, together with one plastic canister containing a molecular sieve desiccant.
Not all pack sizes may be marketed.
Incyte Biosciences Distribution B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Netherlands
Iclusig 15 mg film-coated tablets:
EU/1/13/839/001
EU/1/13/839/002
EU/1/13/839/005
Iclusig 30 mg film-coated tablets:
EU/1/13/839/006
Iclusig 45 mg film-coated tablets:
EU/1/13/839/003
EU/1/13/839/004
Date of first authorisation: 1 July 2013
Date of latest renewal: 8 February 2018
| Drug | Countries | |
|---|---|---|
| ICLUSIG | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States |
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