Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2012 Publisher: GlaxoSmithKline Trading Services Limited 6900 Cork Airport Business Park Kinsale Road Cork Ireland
Revolade 25 mg and 50 mg film-coated tablets.
Film-coated tablet.
25 mg: Round, biconvex, white film-coated tablet debossed with ‘GS NX3’ and ‘25’ on one side.
50 mg: Round, biconvex, brown film-coated tablet debossed with ‘GS UFU’ and ‘50’ on one side.
Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg or 50 mg eltrombopag.
Excipients:
For the full list of excipients, see section 6.1.
Tablet core (25 mg and 50 mg):
Magnesium stearate
Mannitol (E421)
Microcrystalline cellulose
Povidone (K30)
Sodium starch glycolate Type A
Tablet coating (25 mg):
Hypromellose
Macrogol 400
Polysorbate 80
Titanium dioxide (E171)
Tablet coating (50 mg):
Hypromellose
Iron oxide red (E172)
Iron oxide yellow (E172)
Macrogol 400
Titanium dioxide (E171)
Aluminum blisters (PA/Alu/PVC/Alu) in a carton containing 14 or 28 film-coated tablets and multipacks containing 84 (3 packs of 28) film-coated tablets.
Not all pack sizes may be marketed.
GlaxoSmithKline Trading Services Limited
6900 Cork Airport Business Park
Kinsale Road
Cork
Ireland
25 mg (14 tablets): EU/1/10/612/001
25 mg (28 tablets): EU/1/10/612/002
25 mg (84 tablets): EU/1/10/612/003
50 mg (14 tablets): EU/1/10/612/004
50 mg (28 tablets): EU/1/10/612/005
50 mg (84 tablets): EU/1/10/612/006
Date of first authorisation: 11 March 2010
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