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.
| Pharmaceutical Form |
|---|
|
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.
| Active Ingredient | Description | |
|---|---|---|
| Eltrombopag |
Endogenous thrombopoietin (TPO) is the main cytokine involved in regulation of megakaryopoiesis and platelet production, and is the endogenous ligand for the TPO-R. Eltrombopag interacts with the transmembrane domain of the human TPO-R and initiates signalling cascades similar but not identical to that of endogenous thrombopoietin (TPO), inducing proliferation and differentiation from bone marrow progenitor cells. |
| List of Excipients |
|---|
|
Tablet core (25 mg and 50 mg): Magnesium stearate Tablet coating (25 mg): Hypromellose Tablet coating (50 mg): Hypromellose |
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
| Drug | Countries | |
|---|---|---|
| REVOLADE | Austria, Australia, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa |
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