SUTENT Hard capsule Ref.[8511] Active ingredients: Sunitinib

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Product name and form

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.

Qualitative and quantitative composition

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 capsules

Capsule content:

Mannitol (E421)
Croscarmellose sodium
Povidone (K-25)
Magnesium stearate

Capsule shell:

Gelatin
Red iron oxide (E172)
Titanium dioxide (E171)

Printing ink:

Shellac
Propylene glycol
Sodium hydroxide
Povidone
Titanium dioxide (E171)

25 mg hard capsules

Capsule content:

Mannitol (E421)
Croscarmellose sodium
Povidone (K-25)
Magnesium stearate

Capsule shell:

Gelatin
Red iron oxide (E172)
Titanium dioxide (E171)
Yellow iron oxide (E172)
Black iron oxide (E172)

Printing ink:

Shellac
Propylene glycol
Sodium hydroxide
Povidone
Titanium dioxide (E171)

37.5 mg hard capsules

Capsule content:

Mannitol (E421)
Croscarmellose sodium
Povidone (K-25)
Magnesium stearate

Capsule shell:

Gelatin
Titanium dioxide (E171)
Yellow iron oxide (E172)

Printing ink:

Shellac
Propylene glycol
Potassium hydroxide
Black iron oxide (E172)

50 mg hard capsules

Capsule content:

Mannitol (E421)
Croscarmellose sodium
Povidone (K-25)
Magnesium stearate

Capsule shell:

Gelatin
Titanium dioxide (E171)
Yellow iron oxide (E172)
Red iron oxide (E172)
Black iron oxide (E172)

Printing ink:

Shellac
Propylene glycol
Sodium hydroxide
Povidone
Titanium dioxide (E171)

Pack sizes and marketing

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.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Marketing authorization dates and numbers

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

Drugs

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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