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Canada Fingolimod 0.5 mg

1 INDICATIONS AND USAGE Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. (1)

Sun Pharmaceutical Industries, Inc.


2 years ago CAPSULE YELLOW yellow capsule 064 064 Canada Fingolimod 0.5 mg

CAPSULE YELLOW yellow capsule 064 064

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 0.5 mg

FINGOLIMOD capsules are supplied as follows: Hard gelatin capsule, size '4' yellow cap and white body, axially imprinted with '064' on cap and on body in black ink, filled with white to off-white powder. Bottles of 30 with child resistant cap……………………………………...NDC 62756-064-83 Bottles of 90 with child resistant cap……………………………………...NDC 62756-064-81 Carton of 28 capsules containing 2 blister cards of 14 capsules per blister card NDC 62756-064-96 Carton of 7 capsules containing 1 blister card of 7 capsules per blister card NDC 62756-064-59 16.2 Storage and Handling

FINGOLIMOD capsules should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.


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