Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Sutent 12.5 mg hard capsules.
Sutent 25 mg hard capsules.
Sutent 37.5 mg hard capsules.
Sutent 50 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Sutent 12.5 mg hard capsules: Gelatin capsules with orange cap and orange body, printed with white ink “Pfizer” on the cap, “STN 12.5 mg” on the body, and containing yellow to orange granules. Sutent 25 mg hard capsules: Gelatin capsules with caramel cap and orange body, printed with white ink “Pfizer” on the cap, “STN 25 mg” on the body, and containing yellow to orange granules. Sutent 37.5 mg hard capsules: Gelatin capsules with yellow cap and yellow body, printed with black ink “Pfizer” on the cap, “STN 37.5 mg” on the body, and containing yellow to orange granules. Sutent 50 mg hard capsules: Gelatin capsule with caramel cap and caramel body, printed with white ink “Pfizer” on the cap, “STN 50 mg” on the body, and containing yellow to orange granules. |
12.5 mg hard capsules: Each capsule contains sunitinib malate, equivalent to 12.5 mg of sunitinib.
25 mg hard capsules: Each capsule contains sunitinib malate, equivalent to 25 mg of sunitinib.
37.5 mg hard capsules: Each capsule contains sunitinib malate, equivalent to 37.5 mg of sunitinib.
50 mg hard capsules: Each capsule contains sunitinib malate, equivalent to 50 mg of sunitinib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sunitinib |
Sunitinib inhibits multiple RTKs that are implicated in tumour growth, neoangiogenesis, and metastatic progression of cancer. |
| List of Excipients |
|---|
12.5 mg hard capsulesCapsule content: Mannitol (E421) Capsule shell: Gelatin Printing ink: Shellac 25 mg hard capsulesCapsule content: Mannitol (E421) Capsule shell: Gelatin Printing ink: Shellac 37.5 mg hard capsulesCapsule content: Mannitol (E421) Capsule shell: Gelatin Printing ink: Shellac 50 mg hard capsulesCapsule content: Mannitol (E421) Capsule shell: Gelatin Printing ink: Shellac |
High-density polyethylene (HDPE) bottle with a polypropylene closure containing 30 hard capsules.
Poly(chlorotrifluoroethylene)/PVC transparent perforated unit dose blister with aluminium foil coated with heat seal lacquer containing 28 × 1 hard capsules.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Sutent 12.5 mg hard capsules:
EU/1/06/347/001
EU/1/06/347/004
Sutent 25 mg hard capsules:
EU/1/06/347/002
EU/1/06/347/005
Sutent 37.5 mg hard capsules:
EU/1/06/347/007
EU/1/06/347/008
Sutent 50 mg hard capsules:
EU/1/06/347/003
EU/1/06/347/006
Date of first authorisation: 19 July 2006
Date of latest renewal: 9 November 2016
| Drug | Countries | |
|---|---|---|
| SUTENT | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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