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Company McColley SA / Axcan Pharma US Inc. / HP / Axcan Pharma Inc. / / Country France / United States / Brazil / Canada / Argentina / Chile / / Event FDA Phase / / IndustryTerm drug substance manufacturing facility / pancrelipase products / medicinal product / treatment of cystic fibrosis / manufacturing / potential product / / MedicalCondition loss of consciousness / abdominal pain / Pseudomonas / acute otitis / moderate abdominal pain / JE / severe diaper dermatitis / young cystic fibrosis / exocrine pancreatic insufficiency / ischemic colitis / vomiting / pancreatic insufficiency / pancreatitis / chronic pancreatitis / developed sinusitis / diarrhea / steatorrhea / cystic fibrosis / MS / constipation / Streptococcal throat infection / / MedicalTreatment enzyme replacement therapy / antibiotics / / NaturalFeature MT Capsules / / Organization Division of Anti-infective and Ophthalmology Products / Cystic Fibrosis Foundation / / Person David V / Ali Niak / Benjamin Lorenz / Anil Rajpal / / Position reporting physician / author / Acting Team Leader / Medical Officer / / Product ULTRASE Capsules / clarithromycin / MT Capsules / ULTRASE® MT Capsules / ULTRASE® MT20 / Creon / ULTRASE® MT12 / ULTRASE / Zenpep / / Technology amended protocol / /
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