Мальта - англійська - Medicines Authority

octapharma (ip) limited - human albumin solution - solution for infusion - human albumin solution 50 g/l - blood substitutes and perfusion solutions

Кенія - англійська - Pharmacy and Poisons Board

questa care inc. surgilinks building on mombasa road - erythropoietin concentrated solution - intravesical solution/solution for injection - erythropoietin concentrated solution 2000iu/ml - erythropoietin

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

celltrion healthcare australia pty ltd - infliximab, quantity: 120 mg - injection, solution - excipient ingredients: acetic acid; sodium acetate trihydrate; sorbitol; polysorbate 80; water for injections - rheumatoid arthritis in adults remsima in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in: - patients with active disease despite treatment with methotrexate - patients with active disease who have not previously received methotrexate.,remsima should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate.,ankylosing spondylitis remsima is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis remsima is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (dmard) therapy. remsima may be administered in combination with methotrexate.,psoriasis remsima is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. safety and efficacy beyond 12 months have not been established.,crohn?s disease in adults remsima is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies.,refractory fistulising crohn?s disease remsima is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,ulcerative colitis in adults remsimais indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

celltrion healthcare australia pty ltd - infliximab, quantity: 120 mg - injection, solution - excipient ingredients: acetic acid; sodium acetate trihydrate; sorbitol; polysorbate 80; water for injections - rheumatoid arthritis in adults remsima in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in: - patients with active disease despite treatment with methotrexate - patients with active disease who have not previously received methotrexate.,remsima should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate.,ankylosing spondylitis remsima is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis remsima is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (dmard) therapy. remsima may be administered in combination with methotrexate.,psoriasis remsima is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. safety and efficacy beyond 12 months have not been established.,crohn?s disease in adults remsima is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies.,refractory fistulising crohn?s disease remsima is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,ulcerative colitis in adults remsimais indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

celltrion healthcare australia pty ltd - infliximab, quantity: 120 mg - injection, solution - excipient ingredients: acetic acid; sodium acetate trihydrate; sorbitol; polysorbate 80; water for injections - rheumatoid arthritis in adults remsima in combination with methotrexate, is indicated for the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in: - patients with active disease despite treatment with methotrexate - patients with active disease who have not previously received methotrexate.,remsima should be given in combination with methotrexate. efficacy and safety in rheumatoid arthritis have been demonstrated only in combination with methotrexate.,ankylosing spondylitis remsima is indicated for the reduction of signs and symptoms and improvement in physical function in patients with active disease.,psoriatic arthritis remsima is indicated for the treatment of the signs and symptoms, as well as for the improvement in physical function in adult patients with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drug (dmard) therapy. remsima may be administered in combination with methotrexate.,psoriasis remsima is indicated for the treatment of adult patients with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. safety and efficacy beyond 12 months have not been established.,crohn?s disease in adults remsima is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies.,refractory fistulising crohn?s disease remsima is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients.,ulcerative colitis in adults remsimais indicated for the treatment of moderately severe to severe active ulcerative colitis in patients who have had an inadequate response to conventional therapy.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ustekinumab, quantity: 90 mg - injection, solution - excipient ingredients: histidine hydrochloride monohydrate; sucrose; water for injections; polysorbate 80; histidine - plaque psoriasis,adults - stelara is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.,paediatric population, 6 years and older - stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.,psoriatic arthritis (psa),stelara, alone or in combination with methotrexate, is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological dmard therapy has been inadequate.,crohn?s disease,stelara is indicated for the treatment of adult patients with moderately to severely active crohn?s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a tnf alpha antagonist or have medical contraindications to such therapies.,ulcerative colitis,stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

janssen-cilag pty ltd - ustekinumab, quantity: 45 mg - injection, solution - excipient ingredients: histidine; polysorbate 80; histidine hydrochloride monohydrate; water for injections; sucrose - plaque psoriasis,adults - stelara is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.,paediatric population, 6 years and older - stelara is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.,psoriatic arthritis (psa),stelara, alone or in combination with methotrexate, is indicated for the treatment of signs and symptoms of active psoriatic arthritis in adult patients (18 years and older) where response to previous non-biological dmard therapy has been inadequate.,crohn?s disease,stelara is indicated for the treatment of adult patients with moderately to severely active crohn?s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a tnf alpha antagonist or have medical contraindications to such therapies.,ulcerative colitis,stelara is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - epoetin lambda, quantity: 10000 iu - injection, solution - excipient ingredients: sodium chloride; monobasic sodium phosphate dihydrate; dilute hydrochloric acid; glycine; dibasic sodium phosphate dihydrate; polysorbate 80; water for injections; sodium hydroxide - treatment of patients with symptomatic or transfusion requiring anaemia associated with chronic renal failure to improve their quality of life by improving energy levels, exercise performance, fatigue and sleep patterns and by reducing the need for blood transfusions.. treatment of anaemia in patients with nonmyeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy, and where blood transfusion is not considered appropriate. adult patients with mild to moderate anaemia (haemoglobin > 100 to less than or equal to 130g/l) scheduled for elective surgery with an expected moderate blood loss (two to four units or 900 to 1,800ml) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery.. augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients who are scheduled for major elective surgery and who are not expected to predeposit their complete perioperative blood needs.

Австралія - англійська - Department of Health (Therapeutic Goods Administration)

ipsen pty ltd - somatropin, quantity: 5 mg/ml - injection, solution - excipient ingredients: water for injections; phenol; polysorbate 20; sodium citrate dihydrate; citric acid; sodium chloride - long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion. long-term treatment of growth failure associated with turner syndrome. treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. treatment of adults with severe growth hormone deficiency as diagnosed in the insulin tolerance test for growth hormone deficiency and defined by peak gh concentrations of less than 2.5 ng/ml.

Велика Британія - англійська - MHRA (Medicines & Healthcare Products Regulatory Agency)

1%) solution for injection vials (hameln pharma ltd - lidocaine hydrochloride - solution for injection - 10mg/1ml