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

generic health pty ltd - proguanil hydrochloride, quantity: 100 mg; atovaquone, quantity: 250 mg - tablet, film coated - excipient ingredients: purified water; microcrystalline cellulose; poloxamer; colloidal anhydrous silica; povidone; hyprolose; sodium starch glycollate type a; magnesium stearate; titanium dioxide; macrogol 8000; hypromellose; iron oxide red; macrogol 400 - atovaquopro gh is indicated for:,? prophylaxis of plasmodium falciparum malaria in adults and children greater than or equal to 11 kg.,? treatment of plasmodium falciparum malaria in adults and children aged 3 years or older.

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

generic health pty ltd - proguanil hydrochloride, quantity: 100 mg; atovaquone, quantity: 250 mg - tablet, film coated - excipient ingredients: purified water; poloxamer; hyprolose; sodium starch glycollate type a; povidone; colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; macrogol 8000; iron oxide red; macrogol 400 - atovaquopro lapl is indicated for:,? prophylaxis of plasmodium falciparum malaria in adults and children greater than or equal to 11 kg.,? treatment of plasmodium falciparum malaria in adults and children aged 3 years or older.

Bangladeshi - Kiingereza - DGDA (Directorate General of Drug Administration)

labaid pharmaceuticals ltd. - tofacitinib - tablet - 5 mg

Marekani - Kiingereza - NLM (National Library of Medicine)

a-s medication solutions - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt), proguanil hydrochloride (unii: r71y86m0wt) (proguanil - unii:s61k3p7b2v) - atovaquone 250 mg - malarone is indicated for the prophylaxis of plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. malarone is indicated for the treatment of acute, uncomplicated p. falciparum malaria. malarone has been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance. risk summary available data from published literature and postmarketing experience with use of malarone in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. the proguanil component of malarone acts to inhibit parasitic dihydrofolate reductase; however, pregnant women and females of reproductive potential should continue folate supplementation to prevent neural tube defects [see clinical pharmacology (12.1)] . pregnant women with malaria are at increased risk for adverse pregnancy outcomes (see clin

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

pfizer australia pty ltd - tofacitinib citrate, quantity: 1.62 mg/ml (equivalent: tofacitinib, qty 1 mg/ml) - solution - excipient ingredients: xylitol; lactic acid; sucralose; sodium benzoate; hydrochloric acid; purified water; flavour - rheumatoid arthritis (ra),xeljanz is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to methotrexate. xeljanz can be used alone or in combination with conventional synthetic disease-modifying antirheumatic drugs (dmards), including methotrexate.,psoriatic arthritis (psa),xeljanz in combination with conventional synthetic dmards is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response to a prior dmard therapy.,ulcerative colitis (uc),xeljanz is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological therapy.,ankylosing spondylitis (as),xeljanz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy.,juvenile idiopathic arthritis (jia),xeljanz is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis, extended oligoarthritis and systemic juvenile arthritis without systemic features for six months) and juvenile psoriatic arthritis in patients 2 years of age and older, who have responded inadequately to previous therapy with dmards.

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

glaxosmithkline australia pty ltd - atovaquone, quantity: 62.5 mg; proguanil hydrochloride, quantity: 25 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; magnesium stearate; hypromellose; macrogol 8000; microcrystalline cellulose; titanium dioxide; poloxamer; hyprolose; povidone; macrogol 400; iron oxide red - prophylaxis of plasmodium falciparum malaria in adults and children 11kg and over; treatment of plasmodium falciparum malaria in adults and children aged 3 years or older.

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

glaxosmithkline australia pty ltd - atovaquone, quantity: 250 mg; proguanil hydrochloride, quantity: 100 mg - tablet, film coated - excipient ingredients: poloxamer; hyprolose; hypromellose; macrogol 400; magnesium stearate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; macrogol 8000; iron oxide red; povidone - malarone is indicated for the treatment of plasmodium falciparum malaria in adults and children aged 3 years or older. indications as at 1 november 2001: "prophylaxis of plasmodium falciparum malaria in individuals weighing >40kg". this approval is based on the evaluation of the information and data provided with the original letter of application and with any subsequent correspondence and submissions relating to the application. indications as at 13 january 2003: prophylaxis of plasmodium falciparum malaria in adults and children 11kg and over; treatment of plasmodium falciparum malaria in adults and children aged 3 years or older.

Israeli - Kiingereza - Ministry of Health

pfizer pharmaceuticals israel ltd - tofacitinib - tablets - tofacitinib 5 mg - tofacitinib - rheumatoid arthritis tofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards). tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate. psoriatic arthritis tofacitinib in combination with mtx is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (dmard) therapy. ulcerative colitis tofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent ankylosing spondylitis tofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have responded inadequately to conventional therapyjuvenile idiopathic arthritis (jia) tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (psa) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (dmards). tofacitinib can be given in combination with methotrexate (mtx) or as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate.

Israeli - Kiingereza - Ministry of Health

pfizer pharmaceuticals israel ltd - tofacitinib - tablets - tofacitinib 5 mg - tofacitinib - rheumatoid arthritis tofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards). tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate. psoriatic arthritis tofacitinib in combination with mtx is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (dmard) therapy. ulcerative colitis tofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent ankylosing spondylitis tofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have responded inadequately to conventional therapyjuvenile idiopathic arthritis (jia) tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (psa) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (dmards). tofacitinib can be given in combination with methotrexate (mtx) or as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate.

Israeli - Kiingereza - Ministry of Health

pfizer pharmaceuticals israel ltd - tofacitinib as citrate - tablets extended release - tofacitinib as citrate 11 mg - tofacitinib - rheumatoid arthritis:tofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards). tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate.