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

helix pharmaceuticals pty ltd - agomelatine-citric acid, quantity: 44.739 mg (equivalent: agomelatine, qty 25 mg) - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; macrogol 6000; silicified microcrystalline cellulose; purified talc; iron oxide yellow; sodium stearylfumarate; povidone; stearic acid; hypromellose; crospovidone; mannitol; titanium dioxide - treatment of major depressive disorder (mdd) in adults including prevention of relapse.

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

helix pharmaceuticals pty ltd - agomelatine-citric acid, quantity: 44.739 mg (equivalent: agomelatine, qty 25 mg) - tablet, film coated - excipient ingredients: titanium dioxide; iron oxide yellow; colloidal anhydrous silica; purified talc; povidone; sodium stearylfumarate; stearic acid; silicified microcrystalline cellulose; crospovidone; hypromellose; mannitol; macrogol 6000; magnesium stearate - treatment of major depressive disorder (mdd) in adults including prevention of relapse.

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

helix pharmaceuticals pty ltd - agomelatine-citric acid, quantity: 44.739 mg (equivalent: agomelatine, qty 25 mg) - tablet, film coated - excipient ingredients: hypromellose; iron oxide yellow; macrogol 6000; purified talc; colloidal anhydrous silica; mannitol; sodium stearylfumarate; crospovidone; povidone; stearic acid; silicified microcrystalline cellulose; magnesium stearate; titanium dioxide - treatment of major depressive disorder (mdd) in adults including prevention of relapse.

Ireland - English - HPRA (Health Products Regulatory Authority)

b. braun medical limited - gelatine polysuccinate sodium chloride sodium hydroxide - solution for infusion - 4 %w/v

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

servier laboratories ltd - agomelatine - tablet - 25mg

European Union - English - EMA (European Medicines Agency)

les laboratoires servier - agomelatine - depressive disorder, major

European Union - English - EMA (European Medicines Agency)

les laboratoires servier - agomelatine - depressive disorder, major

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

servier laboratories (australia) pty ltd - agomelatine -

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - estriol 0.1%{relative};   - vaginal cream - 0.1 % - active: estriol 0.1%{relative}   excipient: cetyl alcohol chlorhexidine hydrochloride glycerol lactic acid octyldodecanol polysorbate 60 purified water sodium hydroxide sorbitan stearate spermaceti stearyl alcohol - atrophy of the lower urogenital tract related to oestrogen deficiency, notably: · for the treatment of vaginal complaints such as dyspareunia, dryness and itching. · for the prevention of recurrent infections of the vagina and lower urinary tract. · in the management of micturition complaints (such as frequency and dysuria) and mild urinary incontinence. pre- and post-operative therapy in postmenopausal women undergoing vaginal surgery. a diagnostic aid in case of a doubtful atrophic cervical smear.

Ireland - English - HPRA (Health Products Regulatory Authority)

b. braun melsungen ag - succinylated gelatine (= modified fluid gelatine); sodium chloride; sodium acetate trihydrate ; potassium chloride; calcium chloride dihydrate; magnesium chloride hexahydrate - solution for infusion - 4 percent - blood substitutes and plasma protein fractions; gelatin agents