Australia - English - Department of Health (Therapeutic Goods Administration)

specialised therapeutics alim pty ltd - fluocinolone acetonide, quantity: 190 microgram - implant - excipient ingredients: polyvinyl alcohol; pmda/oda copolymer; dimeticonol; ethyltriacetoxysilane; methyltriacetoxysilane; dibutyltin diacetate; silica dimethicone silylate - iluvien is indicated for the treatment of diabetic macular oedema (dme) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (iop).

Ireland - English - HPRA (Health Products Regulatory Authority)

alimera sciences europe limited, - fluocinolone acetonide - intravitreal implant in applicator - 190 microgram(s) - fluocinolone acetonide

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

alimera sciences ltd - fluocinolone acetonide - prolonged-release intravitreal implant - 190microgram

New Zealand - English - Medsafe (Medicines Safety Authority)

specialised therapeutics limited - fluocinolone acetonide 190ug - intraocular implant - 190 mcg - active: fluocinolone acetonide 190ug excipient: med-1137 rtv silicone adhesive polyvinyl alcohol   pyromellitic dianhydride, 4,4'-oxydianiline polymer - for the treatment of diabetic macular oedema (dme) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (iop).

United States - English - NLM (National Library of Medicine)

alimera sciences, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.19 mg - iluvien® (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated for the treatment of diabetic macular edema (dme) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. iluvien is contraindicated in patients with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases. iluvien is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8. iluvien is contraindicated in patients with known hypersensitivity to any components of this product. pregnancy category c there are no adequate and well-controlled studies of iluvien in pregnant women. animal reproduction studies have not been conducted with fluocinolone acetonide. corticosteroids have been shown to be teratogenic in labor

Israel - English - Ministry of Health

megapharm ltd - fluocinolone acetonide - intravitreal injection - fluocinolone acetonide 190 mcg - fluocinolone acetonide - iluvien is indication for the treatment of vision impairment associated with chronic diabetic macular edema (dme), considered insufficiently responsive to available therapies

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

alimera sciences europe ltd. - fluocinolone acetonide 0,19 mg - intravitreal implant in applicator - 190 µg - fluocinolone acetonide 0.19 mg - fluocinolone acetonide

Canada - English - Health Canada

knight therapeutics inc. - fluocinolone acetonide - implant - 0.19mg - fluocinolone acetonide 0.19mg - corticosteroids

Ireland - English - HPRA (Health Products Regulatory Authority)

alimera sciences limited - fluocinolone acetonide - 190 microgram - fluocinolone acetonide