Австралия - английски - Department of Health (Therapeutic Goods Administration)

global harvest pharmaceuticals pty ltd - metaraminol tartrate, quantity: 5.7 mg (equivalent: metaraminol, qty 3 mg) - injection, solution - excipient ingredients: sodium metabisulfite; sodium chloride; water for injections - prevention and treatment of the acute hypotensive state occurring with spinal anaesthesia; adjunctive treatment of hypotension due to haemorrhage, reactions to medications, surgical complications, and shock associated with brain damage due to tumour or trauma. it may also be useful as an adjunct in the treatment of hypotension due to cardiogenic shock or septicaemia

Австралия - английски - Department of Health (Therapeutic Goods Administration)

hameln pharma pty ltd - oxycodone hydrochloride, quantity: 50 mg - injection, solution - excipient ingredients: citric acid monohydrate; hydrochloric acid; sodium citrate dihydrate; water for injections; sodium hydroxide; sodium chloride - oxycodone-hameln solution for injection or infusion is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

hameln pharma pty ltd - oxycodone hydrochloride, quantity: 10 mg - injection, solution - excipient ingredients: sodium citrate dihydrate; sodium hydroxide; sodium chloride; hydrochloric acid; water for injections; citric acid monohydrate - oxycodone-hameln solution for injection or infusion is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

hameln pharma pty ltd - oxycodone hydrochloride, quantity: 20 mg - injection, solution - excipient ingredients: citric acid monohydrate; sodium chloride; hydrochloric acid; sodium citrate dihydrate; water for injections; sodium hydroxide - oxycodone-hameln solution for injection or infusion is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - ephedrine hydrochloride, quantity: 30 mg - injection, solution - excipient ingredients: water for injections - ephedrine hydrochloride injection is indicated in the treatment of hypotension secondary to spinal anaesthesia.

Великобритания - английски - MHRA (Medicines & Healthcare Products Regulatory Agency)

special order - evening primrose oil - cutaneous cream - 200mg/1gram

Европейски съюз - английски - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - teduglutide - malabsorption syndromes - other alimentary tract and metabolism products, - revestive is indicated for the treatment of patients aged 1 year and above with short bowel syndrome (sbs). patients should be stable following a period of intestinal adaptation after surgery.revestive is indicated for the treatment of patients aged 1 year and above with short bowel syndrome. patients should be stable following a period of intestinal adaptation after surgery.

Европейски съюз - английски - EMA (European Medicines Agency)

ucb pharma s.a. - romosozumab - osteoporosis - drugs for treatment of bone diseases - evenity is indicated in treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

samsung bioepis au pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium citrate dihydrate; citric acid monohydrate; sorbitol; polysorbate 20; water for injections; histidine; histidine hydrochloride monohydrate - rheumatoid arthritis: hadlima is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. hadlima can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis hadlima in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying antirheumatic drugs (dmards). hadlima can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis hadlima is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis hadlima is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis hadlima is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (6 years and older) hadlima is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab.,ulcerative colitis hadlima is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see section 5.1 pharmacodynamic properties- clinical trials for ulcerative colitis).,psoriasis in adults and children hadlima is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,hadlima is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),hadlima is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativatherapy.,uveitis hadlima is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

samsung bioepis au pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium citrate dihydrate; citric acid monohydrate; sorbitol; polysorbate 20; water for injections; histidine; histidine hydrochloride monohydrate - rheumatoid arthritis: hadlima is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate. hadlima can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis hadlima in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying antirheumatic drugs (dmards). hadlima can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis hadlima is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis hadlima is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis hadlima is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (6 years and older) hadlima is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients; ? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab.,ulcerative colitis hadlima is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see section 5.1 pharmacodynamic properties- clinical trials for ulcerative colitis).,psoriasis in adults and children hadlima is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,hadlima is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age),hadlima is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativatherapy.,uveitis hadlima is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.