ماليزيا - الإنجليزية - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - budesonide; formoterol fumarate dihydrate -

ماليزيا - الإنجليزية - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - budesonide; formoterol fumarate dihydrate -

كينيا - الإنجليزية - Pharmacy and Poisons Board

budesonide+ formoterol fumarate dihydrate - inhalation vapour - budesonide 200mcg + formoterol fumarate dihydrate… - adrenergics inhalants: adrenergics and other

إسرائيل - الإنجليزية - Ministry of Health

astrazeneca (israel) ltd - budesonide; formoterol fumarate dihydrate; glycopyrronium - suspension for inhalation - formoterol fumarate dihydrate 5 mcg; glycopyrronium 7.2 mcg; budesonide 160 mcg - budesonide - trixeo aerosphere is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (copd) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

mayne pharma inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - budesonide capsules (enteric coated) are indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. budesonide capsules (enteric coated) are indicated for the maintenance of clinical remission of mild to moderate crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). serious hypersensitivity reactions, including anaphylaxis have occurred [see adverse reactions (6.2)] . risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations [see clinical considerations ]. in animal reproduction studies with pregnant rats and rabbits, administration of

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

rising pharmaceuticals, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - budesonide capsules is indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon. pediatric use information is approved for perrigo pharma international dac’s entocort ec (budesonide) capsules. however, due to perrigo pharma international dac’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. budesonide capsules is indicated for the maintenance of clinical remission of mild to moderate crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults. budesonide capsules is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules. serious hypersensitivity reactions, including anaphylaxis have occurred [see adverse reactions (6.2) ]. risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarr

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - budesonide delayed-release capsules are indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. budesonide delayed-release capsules are indicated for the maintenance of clinical remission of mild to moderate crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults. budesonide delayed-release capsules are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide delayed-release capsules. serious hypersensitivity reactions, including anaphylaxis have occurred [see adverse reactions (6.2) ]. limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations [see clinical considerations ]. in animal reproduction studies with pregnant rats and rabbits, administration of subcutaneous bu

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

golden state medical supply, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - budesonide delayed-release capsules are indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. budesonide delayed-release capsules are indicated for the maintenance of clinical remission of mild to moderate crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults. budesonide delayed-release capsules are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide delayed-release capsules. serious hypersensitivity reactions, including anaphylaxis have occurred [ see adverse reactions (6.2) ]. limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations [ see clinical considerations ] . in animal rep

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

apotex corp. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 32 ug - budesonide nasal spray is indicated for the treatment of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children six years of age and older. budesonide nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients [see warnings and precautions (5.2) ]. teratogenic effects: pregnancy category b. the impact of budesonide on human pregnancy outcomes has been evaluated through assessments of birth registries linked with maternal usage of inhaled budesonide (i.e., pulmicort turbuhaler) and intranasally administered budesonide (i.e., budesonide nasal spray). the results from population-based prospective cohort epidemiological studies reviewing data from three swedish registries covering approximately 99% of the pregnancies from 1995- 2001 (i.e., swedish medical birth registry; registry of congenital malformations; child cardiology registry) indicate no increased risk for overall congenital malformations from the use of inhaled or intranasal budesonide during ea

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 0.5 mg in 2 ml - budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. important limitations of use: • budesonide inhalation suspension is not indicated for the relief of acute bronchospasm. the use of budesonide inhalation suspension is contraindicated in the following conditions: pregnancy category b studies of pregnant women, have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. the results from a large population-based prospective cohort epidemiological study reviewing data from three swedish registries covering approximately 99% of the pregnancies from 1995 to 1997 (i.e., swedish medical birth registry; registry of congenital malformations; child cardiology registry) indicate no increased risk for congenital malformations from the use of inhaled budesonide during early pregnancy. congenital malformations were studied in 2014 infants born to mothers reporting the use