Ireland - English - HPRA (Health Products Regulatory Authority)

chanelle pharmaceuticals manufacturing limited - triclabendazole; ivermectin - oral suspension - ivermectin, combinations

Ireland - English - HPRA (Health Products Regulatory Authority)

t. p. whelehan son & co. limited -

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

syngenta australia pty ltd - difenoconazole; liquid hydrocarbon - emulsifiable concentrate - difenoconazole triazole active 250.0 g/l; liquid hydrocarbon solvent other 500.0 g/l - fungicide - banana - see label | carrot | macadamia nut | potato | tomato | root - black sigatoka | early blight or target blackspot | husk spot - pseudocercospora macadamiae | leaf blight - a. dauci & c. carotae | leaf spot or yellow sigatoka on banana | sigatoka | target spot | yellow sigatoka

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

elanco australasia pty ltd - tilmicosin - parenteral liquid/solution/suspension - tilmicosin antibiotic active 300.0 mg/ml - antibiotic & related - cattle | beef | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf | cow | dairy cow | heifer | steer - bovine respiratory disease | mannheimia haemolytica | pasteurella multocida | fowl cholera | shipping fever

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - bosentan monohydrate 129.082mg equivalent to bosentan anhydrous 125 mg;  ; bosentan monohydrate 129.082mg equivalent to bosentan anhydrous 125 mg - film coated tablet - 125 mg - active: bosentan monohydrate 129.082mg equivalent to bosentan anhydrous 125 mg   excipient: glyceryl behenate magnesium stearate maize starch opadry yellow 03k82318 povidone sodium laurilsulfate sodium starch glycolate starch surelease clear e-7-19040 as solid active: bosentan monohydrate 129.082mg equivalent to bosentan anhydrous 125 mg excipient: glyceryl behenate magnesium stearate maize starch opadry white 03k580000 povidone sodium laurilsulfate sodium starch glycolate starch surelease clear e-7-19040 as solid - indicated for the treatment of idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension, pulmonary arterial hypertension associated with scleroderma or pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger's physiology in patients with who class iii or iv symptoms.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - bosentan monohydrate 64.541mg equivalent to bosentan anhydrous 62.5 mg;  ; bosentan monohydrate 64.541mg equivalent to bosentan anhydrous 62.5 mg - film coated tablet - 62.5 mg - active: bosentan monohydrate 64.541mg equivalent to bosentan anhydrous 62.5 mg   excipient: glyceryl behenate magnesium stearate maize starch opadry yellow 03k82318 povidone sodium laurilsulfate sodium starch glycolate starch surelease clear e-7-19040 as solid active: bosentan monohydrate 64.541mg equivalent to bosentan anhydrous 62.5 mg excipient: glyceryl behenate magnesium stearate maize starch opadry white 03k580000 povidone sodium laurilsulfate sodium starch glycolate starch surelease clear e-7-19040 as solid - indicated for the treatment of idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension, pulmonary arterial hypertension associated with scleroderma or pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger's physiology in patients with who class iii or iv symptoms.

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - bosentan monohydrate 125mg;   - film coated tablet - 125 mg - active: bosentan monohydrate 125mg   excipient: magnesium stearate opadry orange 03k93638 povidone pregelatinised maize starch sodium starch glycolate - indicated for the treatment of idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension, pulmonary arterial hypertension associated with scleroderma or pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger's physiology in patients with who class iii or iv symptoms.

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - bosentan monohydrate 62.5mg;   - film coated tablet - 62.5 mg - active: bosentan monohydrate 62.5mg   excipient: magnesium stearate opadry orange 03k93638 povidone pregelatinised maize starch sodium starch glycolate - indicated for the treatment of idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension, pulmonary arterial hypertension associated with scleroderma or pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger's physiology in patients with who class iii or iv symptoms.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - bosentan 125mg;   - film coated tablet - 125 mg - active: bosentan 125mg   excipient: ethylcellulose glyceryl behenate hypromellose iron oxide red iron oxide yellow magnesium stearate maize starch povidone purified talc sodium starch glycolate starch titanium dioxide triacetin - tracleer® is indicated for the treatment of idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension, pulmonary arterial hypertension associated with scleroderma or pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger's physiology in patients with who class iii or iv symptoms.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - bosentan 62.5mg (as monohydrate);   - film coated tablet - 62.5 mg - active: bosentan 62.5mg (as monohydrate)   excipient: ethylcellulose glyceryl behenate hypromellose iron oxide red iron oxide yellow magnesium stearate maize starch povidone purified talc sodium starch glycolate starch titanium dioxide triacetin - tracleer® is indicated for the treatment of idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension, pulmonary arterial hypertension associated with scleroderma or pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger's physiology in patients with who class iii or iv symptoms.