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

iroko pharmaceuticals llc - diclofenac (unii: 144o8ql0l1) (diclofenac - unii:144o8ql0l1) - diclofenac 18 mg - zorvolex is indicated for: - management of mild to moderate acute pain - management of osteoarthritis pain zorvolex is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see warnings and precautions (5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1) ] pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation. risk summary use of nsaids, including zorvolex, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including zorvolex, in pregnant women starting at 30 weeks of gestation

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

iroko pharmaceuticals, llc - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 40 mg - tivorbex is indicated for treatment of mild to moderate acute pain in adults. tivorbex is contraindicated in the following patients:  - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see warnings and precautions ( 5.7 , 5.9 ) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions ( 5.7 ,   5.8 ) ]  - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions ( 5.1 ) ] pregnancy category c in the first and second trimesters of pregnancy; category d in the third trimester. risk summary use of nsaids, including tivorbex, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including tivorbex, in pregnant women starting at 30 weeks of ge

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

iroko pharmaceuticals, llc - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 25 mg in 5 ml - indocin oral suspension is indicated for: - moderate to severe rheumatoid arthritis including acute flares of chronic disease - moderate to severe ankylosing spondylitis - moderate to severe osteoarthritis - acute painful shoulder (bursitis and/or tendinitis) - acute gouty arthritis  indocin is contraindicated in the following patients:  - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see warnings and precautions ( 5.7 , 5.9 ) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions ( 5.7 ,   5.8 ) ]  - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions ( 5.1 ) ] risk summary use of nsaids, including indocin, during the third trimester of pregnancy increases the risk of premature closure of the fetal duct

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

iroko pharmaceuticals, llc - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 50 mg - indocin suppository is indicated for: - moderate to severe rheumatoid arthritis including acute flares of chronic disease - moderate to severe ankylosing spondylitis - moderate to severe osteoarthritis - acute painful shoulder (bursitis and/or tendinitis) - acute gouty arthritis indocin is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see warnings and precautions (5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1) ] - in patients with a history of proctitis or recent rectal bleeding use of nsaids, including indocin, during the third trimester of pregnancy increases the risk of p

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

iroko pharmaceuticals, llc - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam 5 mg - vivlodex is indicated for management of osteoarthritis pain. vivlodex is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [see warnings and precautions (5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1) ] risk summary use of nsaids, including vivlodex, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including vivlodex, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of vivlodex in pregnant women. data from observational studies rega

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: n/a; distributor: n/a - multivitamins , minerals - effervescent tablet - 500 mg/ 100 mg/ 100 mg/ 50 mg/ 23 mg/ 15 mg/ 15 mg/ 10 mg/ 10 mg/ 400 mcg/ 150 mcg/ 10 mcg

Ireland - English - HPRA (Health Products Regulatory Authority)

iroko cardio (uk) ltd - tirofiban hydrochloride monohydrate - solution for infusion - 0.05mg/ml mg/ml

European Union - English - EMA (European Medicines Agency)

zentiva k.s. - efavirenz, emtricitabine, tenofovir disoproxil, phosphate - hiv infections - antivirals for systemic use, - efavirenz/emtricitabine/tenofovir disoproxil zentiva is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. it is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults aged 18 years and over with virologic suppression to hiv-1 rna levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in efavirenz/emtricitabine/tenofovir disoproxil zentiva prior to initiation of their first antiretroviral treatment regimen., the demonstration of the benefit of the combination efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavir

Nigeria - English - NAFDAC (National Agency for Food and Drugs Administration and Control)

ibuprofen 100mg/5ml

Nigeria - English - NAFDAC (National Agency for Food and Drugs Administration and Control)

paracetamol 125mg/5ml