Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Ipsen Pharma, 70 rue Balard, 75015 Paris, France
COMETRIQ 20 mg hard capsules.
COMETRIQ 80 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. The hard capsules are grey with "XL184 20mg" printed in black on the body of the capsule. The capsule contains an off-white to white powder. The hard capsules are orange with "XL184 80mg" printed in black on the body of the capsule. The capsule contains an off-white to white powder. |
One hard capsule contains cabozantinib (S)-malate equivalent to 20 mg or 80 mg cabozantinib.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Cabozantinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumour growth and angiogenesis, pathologic bone remodeling, drug resistance, and metastatic progression of cancer. Cabozantinib was evaluated for its inhibitory activity against a variety of kinases and was identified as an inhibitor of MET (hepatocyte growth factor receptor protein) and VEGF (vascular endothelial growth factor) receptors. In addition, cabozantinib inhibits other tyrosine kinases including the GAS6 receptor (AXL), RET, ROS1, TYRO3, MER, the stem cell factor receptor (KIT), TRKB, Fms-like tyrosine kinase-3 (FLT3), and TIE-2. |
| List of Excipients |
|---|
|
Capsule content: Microcrystalline cellulose Capsule shell: Gelatin Printing ink: Shellac |
PVC/PE/PCTFE-Al blisters with foil backing, sealed into a secondary heat-sealed card packaging.
Blister cards containing either:
21 x 20 mg capsules (60 mg/day dose for a 7-day supply)
7 x 20 mg and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply)
21 x 20 mg and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply)
28 day pack containing:
84 capsules (4 blister cards of 21 x 20 mg) (60 mg/day dose for a 28 day supply)
56 capsules (4 blister cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for a 28 day supply)
112 capsules (4 blister cards of 21 x 20mg and 7 x 80 mg) (140 mg/day dose for a 28 day supply)
Ipsen Pharma, 70 rue Balard, 75015 Paris, France
EU/1/13/890/001 21 x 20 mg capsules (60 mg/day dose for a 7-day supply)
EU/1/13/890/002 7 x 20 mg and 7 x 80 mg capsules (100 mg/day dose for a 7-day supply)
EU/1/13/890/003 21 x 20 mg and 7 x 80 mg capsules (140 mg/day dose for a 7-day supply)
EU/1/13/890/004 84 capsules (4 blister cards of 21 x 20 mg) (60 mg/day dose for a 28 day supply)
EU/1/13/890/005 56 capsules (4 blister cards of 7 x 20 mg and 7 x 80 mg) (100 mg/day dose for 28 day supply)
EU/1/13/890/006 112 capsules (4 blister cards of 21 x 20mg and 7 x 80 mg) (140 mg/day dose for 28 day supply)
Date of first authorisation: 21 March 2014
Date of latest renewal: 11 February 2021
| Drug | Countries | |
|---|---|---|
| COMETRIQ | Austria, Estonia, Finland, Croatia, Ireland, Lithuania, Netherlands, Poland, United Kingdom, United States |
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