United States - English - NLM (National Library of Medicine)

ironwood pharmaceuticals, inc. - lesinurad (unii: 09erp08i3w) (lesinurad - unii:09erp08i3w), allopurinol (unii: 63cz7gjn5i) (allopurinol - unii:63cz7gjn5i) - lesinurad 200 mg - duzallo®, a combination of lesinurad, a uric acid transporter 1 (urat1) inhibitor, and allopurinol, a xanthine oxidase inhibitor, is indicated for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone [see clinical studies (14) ]. duzallo is not recommended for the treatment of asymptomatic hyperuricemia. the use of duzallo is contraindicated in the following conditions: - severe renal impairment (eclcr less than 30 ml/min), end-stage renal disease, kidney transplant recipients, or patients on dialysis [see use in specific populations (8.6) ]. - tumor lysis syndrome or lesch-nyhan syndrome [see use in specific populations (8.8) ]. - known hypersensitivity to allopurinol, including previous occurrence of skin rash [see warnings and precautions (5.2) ]. risk summary there are no available human data on use of duzallo or lesinurad in pregnant women to inform a drug-associated risk of adverse

United States - English - NLM (National Library of Medicine)

ironwood pharmaceuticals, inc. - lesinurad (unii: 09erp08i3w) (lesinurad - unii:09erp08i3w) - lesinurad 200 mg - zurampic is indicated in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone [see clinical studies (14) ]. zurampic is not recommended for the treatment of asymptomatic hyperuricemia. zurampic should not be used as monotherapy [see warnings and precautions (5.1) ]. the use of zurampic is contraindicated in the following conditions: - severe renal impairment (eclcr less than 30 ml/min), end stage renal disease, kidney transplant recipients, or patients on dialysis [see use in specific populations (8.6) ] - tumor lysis syndrome or lesch-nyhan syndrome [see use in specific populations (8.8) ]. risk summary there are no available human data on use of zurampic in pregnant women to inform a drug-associated risk. no teratogenicity or effects on fetal development were observed in embryo-fetal development studies with oral administration of lesinurad to pregnant rats

United States - English - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - lesinurad (unii: 09erp08i3w) (lesinurad - unii:09erp08i3w) - lesinurad 200 mg

European Union - English - EMA (European Medicines Agency)

grünenthal gmbh - lesinurad - hyperuricemia - antigout preparations - zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.,

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

astrazeneca pty ltd - lesinurad -

European Union - English - EMA (European Medicines Agency)

grunenthal gmbh - allopurinol, lesinurad - gout - antigout preparations - duzallo is indicated in adults for the treatment of hyperuricaemia in gout patients who have not achieved target serum uric acid levels with an adequate dose of allopurinol alone.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - lesinurad 200 mg - film coated tablet - 200 mg

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - doravirine, lamivudine, tenofovir disoproxil fumarate - hiv infections - antivirals for treatment of hiv infections, combinations - delstrigo is indicated for the treatment of adults infected with hiv 1 without past or present evidence of resistance to the nnrti class, lamivudine, or tenofovir.delstrigo is also indicated for the treatment of adolescents aged 12 years and older weighing at least 35 kg who are infected with hiv-1 without past or present evidence of resistance to the nnrti class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil.

European Union - English - EMA (European Medicines Agency)

merck sharp & dohme b.v. - doravirine - hiv infections - antivirals for systemic use - pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with hiv 1 without past or present evidence of resistance to the nnrti class.

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - doravirine - film coated tablets - doravirine 100 mg - doravirine - pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with hiv-1 without past or present evidence of viral resistance to doravirine.