| Document Date: 2013-05-09 03:40:32
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City San José / Aztreonam / / Company Article 45 / Bristol-Myers Squibb Company / The AEs / Bristol-Myers Squibb / / Country Netherlands / United Kingdom / Costa Rica / / Event FDA Phase / / Facility National Children's Hospital / Azactam INN / / IndustryTerm pharmaceutical form / pharmaceutical formulation / year old age / treatment of cystic fibrosis / / MedicalCondition F Pneumonia / Pseudomonas / suspected Gram-negative infections / gram-negative meningitis / joint infections / cutaneous infections / documented bacterial infection / aeroginosa infections / Gynaecological infections / pelvic inflammatory disease / bronchitis / endometritis / Study population /Sample size Thirty-one cystic fibrosis / Haemophilus influenza / primary infection / septicaemia / central nervous system infection / Skin infections / burns / neonatal bacterial infections / Urinary tract infections / cystic fibrosis / soft tissue infections / suspected sepsis / Intra-abdominal infections / infections / Bacteremia/Septicemia / pneumonia / i.e. peritonitis / Gram-negative infections / documented sepsis / disease / Lower respiratory tract infection / shock / aeruginosa pulmonary infections / documented infection / lower respiratory tract Pseudomonas / M Pneumonia / abscesses / acute pulmonary exacerbation / Superinfection / urinary and respiratory tract infections / documented infections / acute pulmonary exacerbations / bacterial infection / infection / gram-negative bacterial pulmonary infections / meningitis / Urinary Tract Infections Meningitis Lower Respiratory Tract Infections / eosinophilia / pelvic cellulitis / / MedicalTreatment antibiotics / surgery / intravenous infusion / adjunctive therapy / antibiotic therapy / / Organization National Children's Hospital / Council for International Organizations of Medical Sciences III/V / Neonatal Intensive Care Unit / / Position EXECUTIVE / Fisher / / Product penicillin / ampicillin / Azactam / tobramycin / SCIENTIFIC DISCUSSION Aztreonam / Shure E2c Headphone/Headset / aztreonam / / Technology Pharmacokinetics / 8/15 Protocol / /
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Public Assessment Report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No1901/2006, as amended Azactam a.o.