New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - pancreatin 300mg (amylase 18,000 ph eur u, lipase 25,000 ph eur u, total protease 1,000 ph eur u.); pancreatin 300mg equivalent to amylase 18,000 ph eur u, lipase 25,000 ph eur u, total protease 1,000 ph eur u; pancreatin 300mg equivalent to amylase 18,000 ph eur u, lipase 25,000 ph eur u, total protease 1,000 ph eur u - modified release capsule - 300 mg - active: pancreatin 300mg (amylase 18,000 ph eur u, lipase 25,000 ph eur u, total protease 1,000 ph eur u.) excipient: acetone dibutyl phthalate dimeticone gelatin hypromellose phthalate iron oxide red iron oxide yellow liquid paraffin macrogol 4000 propyl alcohol titanium dioxide active: pancreatin 300mg equivalent to amylase 18,000 ph eur u, lipase 25,000 ph eur u, total protease 1,000 ph eur u excipient: cetyl alcohol dimeticone gelatin hypromellose phthalate iron oxide red iron oxide yellow macrogol 4000 sodium laurilsulfate titanium dioxide triethyl citrate active: pancreatin 300mg equivalent to amylase 18,000 ph eur u, lipase 25,000 ph eur u, total protease 1,000 ph eur u excipient: cetyl alcohol dimeticone gelatin hypromellose phthalate iron oxide red iron oxide yellow macrogol 4000 sodium laurilsulfate triethyl citrate - creon is indicated for the treatment of pancreatic exocrine insufficiency (pei) in paediatric and adult patients. pancreatic exocrine insufficiency is often associated with, but not limited to: · cystic fibrosis · chronic pancreatitis · post-pancreatectomy · post-gastrointestinal bypass surgery ,(e.g. billroth ii, gastroenterostomy) · ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm).

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

viatris uk healthcare ltd - amylase; lipase; protease - gastro-resistant capsule - 8000unit ; 10000unit ; 600unit

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

viatris uk healthcare ltd - amylase; lipase; protease - gastro-resistant capsule - 25000unit ; 40000unit ; 1600unit

Malta - English - Medicines Authority

mylan products limited - lipase; amylase; protease - capsule - lipase 10000 u; amylase 8000 u; protease 600 u - digestives, incl. enzymes

Malta - English - Medicines Authority

mylan products limited - lipase; amylase; protease - capsule - lipase 25000 u; amylase 18000 u; protease 1000 u - digestives, incl. enzymes

Canada - English - Health Canada

merck canada inc - lipase; amylase; protease; bile salts; cellulase - capsule - 8000unit; 30000unit; 30000unit; 65mg; 2mg - lipase 8000unit; amylase 30000unit; protease 30000unit; bile salts 65mg; cellulase 2mg - digestants

Canada - English - Health Canada

mcneil pharmaceutical, division of ortho-mcneil inc. - lipase; amylase; protease - capsule (enteric-coated) - 4000unit; 20000unit; 25000unit - lipase 4000unit; amylase 20000unit; protease 25000unit - digestants

Canada - English - Health Canada

kali-chemie pharma gmbh - lipase; amylase; protease - capsule - 8000unit; 30000unit; 13000unit - lipase 8000unit; amylase 30000unit; protease 13000unit - digestants

Canada - English - Health Canada

axcan pharma inc - lipase; amylase; protease - capsule - 8000unit; 30000unit; 30000unit - lipase 8000unit; amylase 30000unit; protease 30000unit - digestants

Canada - English - Health Canada

merck canada inc - lipase; amylase; protease - capsule - 4000unit; 11000unit; 11000unit - lipase 4000unit; amylase 11000unit; protease 11000unit - digestants