Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Gilenya 0.25 mg hard capsules.
Gilenya 0.5 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Gilenya 0.25 mg hard capsules: Capsule of 16 mm with ivory opaque cap and body, with black radial imprint “FTY 0.25mg” on cap and black radial band on body. Gilenya 0.5 mg hard capsules: Capsule of 16 mm with bright yellow opaque cap and white opaque body; imprint with black ink, “FTY0.5 mg” on cap and two radial bands imprinted on the body with yellow ink. |
Gilenya 0.25 mg hard capsules: Each 0.25 mg capsule contains 0.25 mg fingolimod (as hydrochloride).
Gilenya 0.5 mg hard capsules: Each 0.5 mg capsule contains 0.5 mg fingolimod (as hydrochloride).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Fingolimod |
Fingolimod is a sphingosine 1-phosphate receptor modulator. Fingolimod is metabolised by sphingosine kinase to the active metabolite fingolimod phosphate. By acting as a functional antagonist of S1P receptors on lymphocytes, fingolimod phosphate blocks the capacity of lymphocytes to egress from lymph nodes, causing a redistribution, rather than depletion, of lymphocytes. |
| List of Excipients |
|---|
Gilenya 0.25 mg hard capsulesCapsule fill: Mannitol Capsule shell: Gelatin Printing ink: Shellac (E904) Gilenya 0.5 mg hard capsulesCapsule fill: Mannitol Capsule shell: Gelatin Printing ink: Shellac (E904) |
Gilenya 0.25 mg hard capsules:
PVC/PVDC/aluminium blister packs containing 28 hard capsules.
PVC/PVDC/aluminium perforated unit dose blister packs containing 7x 1 hard capsules.
Gilenya 0.5 mg hard capsules:
PVC/PVDC/aluminium blister packs containing 7, 28 or 98 hard capsules or multipacks containing 84 (3 packs of 28) hard capsules.
PVC/PVDC/aluminium perforated unit dose blister packs containing 7x 1 hard capsules.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Gilenya 0.25 mg hard capsules: EU/1/11/677/007-008
Gilenya 0.5 mg hard capsules: EU/1/11/677/001-006
Date of first authorisation: 17 March 2011
Date of latest renewal: 23 November 2015
| Drug | Countries | |
|---|---|---|
| GILENYA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, United States |
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