Malta - Kiingereza - Medicines Authority

krka dd novo mesto novo mesto, Šmarješka cesta 6, 8501 novo mesto, slovenia - agomelatine - film-coated tablet - agomelatine 25 milligram(s) - psychoanaleptics

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

arrotex pharmaceuticals pty ltd - paracetamol, quantity: 498.9288 mg - tablet, gelatin coated - excipient ingredients: titanium dioxide; sodium lauryl sulfate; allura red ac; gelatin; hypromellose; pregelatinised maize starch; stearic acid; povidone - temporary relief of pain associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, arthritis, osteoarthritis, rheumatic pain, period pain, fibrositis, neuralgia, sore throat, tennis elbow, and colds and flu. reduces fever.

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

juno pharmaceuticals pty ltd - pomalidomide, quantity: 3 mg - capsule, hard - excipient ingredients: pregelatinised starch; sodium stearylfumarate; mannitol; croscarmellose sodium; titanium dioxide; indigo carmine; purified water; iron oxide yellow; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia; potassium hydroxide - pomalidomide, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide.,pomalidomide, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

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

juno pharmaceuticals pty ltd - pomalidomide, quantity: 2 mg - capsule, hard - excipient ingredients: croscarmellose sodium; mannitol; sodium stearylfumarate; pregelatinised starch; titanium dioxide; indigo carmine; purified water; iron oxide yellow; erythrosine; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia; potassium hydroxide - pomalidomide, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide.,pomalidomide, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

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

juno pharmaceuticals pty ltd - pomalidomide, quantity: 1 mg - capsule, hard - excipient ingredients: pregelatinised starch; croscarmellose sodium; mannitol; sodium stearylfumarate; titanium dioxide; indigo carmine; purified water; iron oxide yellow; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; ethanol absolute; ammonia - pomalidomide, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide.,pomalidomide, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

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

juno pharmaceuticals pty ltd - pomalidomide, quantity: 4 mg - capsule, hard - excipient ingredients: pregelatinised starch; mannitol; sodium stearylfumarate; croscarmellose sodium; titanium dioxide; indigo carmine; purified water; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia; potassium hydroxide - pomalidomide, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide.,pomalidomide, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

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

johnson & johnson pacific pty ltd - paracetamol, quantity: 500 mg - tablet, gelatin coated - excipient ingredients: sodium lauryl sulfate; starch; gelatin; sodium starch glycollate; magnesium stearate; powdered cellulose; pregelatinised starch; hypromellose; propylene glycol; purified water; isopropyl alcohol; iron oxide black; titanium dioxide; polysorbate 80; iron oxide yellow; iron oxide red; macrogol 400; brilliant blue fcf; allura red ac; benzyl alcohol; methyl hydroxybenzoate; propyl hydroxybenzoate; butyl hydroxybenzoate; carmellose sodium; sodium calcium edetate; sodium propionate; quinoline yellow - temporary relief of pain associated with headache, migraine headache, tension headache, sinus pain, toothache, dental procedures, backache, muscular aches and pains, arthritis, osteoarthritis, rheumatic pain, period pain, fibrositis, neuralgia, sore throat, tennis elbow, and colds and flu. reduces fever.

Australia - Kiingereza - 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: mannitol; crospovidone; purified talc; povidone; titanium dioxide; silicified microcrystalline cellulose; macrogol 6000; hypromellose; stearic acid; colloidal anhydrous silica; sodium stearylfumarate; magnesium stearate; iron oxide yellow - treatment of major depressive disorder (mdd) in adults including prevention of relapse.

Umoja wa Ulaya - Kiingereza - EMA (European Medicines Agency)

servier (ireland) industries ltd - agomelatine - depressive disorder, major - psychoanaleptics, - treatment of major depressive episodes in adults.

Umoja wa Ulaya - Kiingereza - EMA (European Medicines Agency)

les laboratoires servier - agomelatine - depressive disorder, major - psychoanaleptics, - treatment of major depressive episodes in adults.,