Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Revolade 12.5 mg film-coated tablets.
Revolade 25 mg film-coated tablets.
Revolade 50 mg film-coated tablets.
Revolade 75 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Revolade 12.5 mg film-coated tablets: White, round, biconvex film-coated tablet (approximately 7.9 mm in diameter) debossed with ‘GS MZ1’ and ‘12.5’ on one side. Revolade 25 mg film-coated tablets: White, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS NX3’ and ‘25’ on one side. Revolade 50 mg film-coated tablets: Brown, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS UFU’ and ‘50’ on one side. Revolade 75 mg film-coated tablets: Pink, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS FFS’ and ‘75’ on one side. |
Revolade 12.5 mg film-coated tablets: Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg eltrombopag.
Revolade 25 mg film-coated tablets: Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag.
Revolade 50 mg film-coated tablets: Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag.
Revolade 75 mg film-coated tablets: Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg eltrombopag.
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 |
|---|
|
Revolade 12.5 mg film-coated tablets: Tablet core: Magnesium stearate Tablet coating: Hypromellose (E464) Revolade 25 mg film-coated tablets: Tablet core: Magnesium stearate Tablet coating: Hypromellose (E464) Revolade 50 mg film-coated tablets: Tablet core: Magnesium stearate Tablet coating: Hypromellose (E464) Revolade 75 mg film-coated tablets: Tablet core: Magnesium stearate Tablet coating: Hypromellose (E464) |
Film-coated tablets: 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.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Revolade 12.5 mg film-coated tablets:
EU/1/10/612/010
EU/1/10/612/011
EU/1/10/612/012
Revolade 25 mg film-coated tablets:
EU/1/10/612/001
EU/1/10/612/002
EU/1/10/612/003
Revolade 50 mg film-coated tablets:
EU/1/10/612/004
EU/1/10/612/005
EU/1/10/612/006
Revolade 75 mg film-coated tablets:
EU/1/10/612/007
EU/1/10/612/008
EU/1/10/612/009
Date of first authorisation: 11 March 2010
Date of latest renewal: 15 January 2015
| 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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