F1 generation pup survival was decreased in the early postpartum period at doses that did not cause maternal toxicity. However, F1 body weights, development, behaviour, and fertility were not affected by treatment with fingolimod.
Fingolimod was excreted in milk of treated animals during lactation. Fingolimod and its metabolites crossed the placental barrier in pregnant rabbits.
Environmental Risk Assessment (ERA)
A risk for the environment due to use of Gilenya by patients with relapsing multiple sclerosis is not expected.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Capsule core:
Magnesium stearate
Mannitol
Capsule shell:
Yellow iron oxide (E172)
Titanium dioxide (E171)
Gelatin
Printing ink:
Shellac (E904)
Dehydrated alcohol
Isopropyl alcohol
Butyl alcohol
Propylene glycol
Purified water
Strong ammonia solution
Potassium hydroxide
Black iron oxide (E172)
Yellow iron oxide (E172)
Titanium dioxide (E171)
Dimethicone
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years
6.4 Special precautions for storage
Do not store above 30°C.
Store in the original package in order to protect from moisture.
6.5 Nature and contents of container
PVC/PVDC/aluminium blister packs containing 7 or 28 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.
6.6 Special precautions for disposal and other handling
No special requirements.
7. MARKETING AUTHORISATION HOLDER
Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/11/677/001-005
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17.03.2011
10. DATE OF REVISION OF THE TEXT
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
