SUTENT® 12.5 mg, 25 mg, 37.5 mg, 50 mg hard capsules

Capsule content

Mannitol (E421)

Croscarmellose Sodium

Povidone (K-25)

Magnesium Stearate

SUTENT® 12.5 mg, 25 mg hard capsules

Orange Capsule Shell

Gelatin

Red Iron Oxide (E172)

Titanium dioxide (E171)

SUTENT® 25 mg, 50 mg hard capsules

Caramel Capsule Shell

Gelatin

Titanium dioxide (E171)

Yellow Iron Oxide (E172)

Red Iron Oxide (E172)

Black Iron Oxide (E172)

SUTENT® 37.5 mg hard capsules

Yellow Capsule Shell

Gelatin

Titanium dioxide (E171)

Yellow Iron Oxide (E172)

SUTENT® 12.5 mg, 25 mg, 50 mg hard capsules

Printing ink.

Shellac

Propylene glycol

Sodium hydroxide

Povidone

Titanium dioxide (E171)

SUTENT® 37.5 mg hard capsules

Printing ink.

Shellac

Propylene glycol

Potassium hydroxide

Black Iron Oxide (E172)

6.2 Incompatibilities

 Not applicable.

6.3 Shelf life

 3 years.

6.4 Special precautions for storage

 This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

 High-density polyethylene (HDPE) bottle with a polypropylene closure containing 30 hard capsules.

Aclar/PVC transparent blister with aluminium foil coated with heat seal lacquer containing 28 (4 x 7) hard capsules

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

 No special requirements.

7. MARKETING AUTHORISATION HOLDER

 Pfizer Ltd

Ramsgate Road

Sandwich, Kent CT13 9NJ

United Kingdom

8. MARKETING AUTHORISATION NUMBER(S)

 EU/1/06/347/001-008

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 Date of first authorisation: July 19, 2006

Due-date for next renewal: July 19, 2011

10. DATE OF REVISION OF THE TEXT

 18th August 2011

LEGAL CATEGORY

 POM