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

Ireland - English - HPRA (Health Products Regulatory Authority)

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

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

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

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

alimera sciences, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - yutiq® (fluocinolone acetonide intravitreal implant) 0.18 mg is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. yutiq 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. yutiq is contraindicated in patients with known hypersensitivity to any components of this product. risk summary adequate and well-controlled studies with yutiq have not been conducted in pregnant women to inform drug associated risk. animal reproduction studies have not been conducted with yutiq. it is not known whether yutiq can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage leve

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

European Union - English - EMA (European Medicines Agency)

amicus therapeutics europe limited - miglustat - glycogen storage disease type ii - other alimentary tract and metabolism products - opfolda (miglustat) is an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in adults with late-onset pompe disease (acid α- glucosidase [gaa] deficiency).

European Union - English - EMA (European Medicines Agency)

amicus therapeutics europe limited - cipaglucosidase alfa - glycogen storage disease type ii - other alimentary tract and metabolism products, - pombiliti (cipaglucosidase alfa) is a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset pompe disease (acid α-glucosidase [gaa] deficiency).