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Revolade (2012)

Active ingredients: Eltrombopag

Product Name and Form

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.

Qualitative and Quantitative Composition

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.

Chemical substance
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
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)

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

GlaxoSmithKline Trading Services Limited
6900 Cork Airport Business Park
Kinsale Road
Cork
Ireland

Date of first authorisation: 11 March 2010

Marketing authorization number:

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