CSR Synopses following approval of a new medicine or a new indication for an approved medicine in the US or EU. We are making CSR synopses available to supplement the public information available to patients and healthcare providers about the results of our clinical trials and the evidence used to approve a new medicine or a new indication.
Pancrelipase: CREON
Study Name | |||
---|---|---|---|
S245.3.123
|
Chronic Pancreatitis | Phase 3 | A One-year Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Patients With Pancreatic Exocrine Insufficiency Caused by Chronic Pancreatitis or by Pancreatectomy |
JSPP-12-01
|
Cystic Fibrosis | PMOS | A Point Prevalence Study to Evaluate the Prevalence of Antibodies to Selected Porcine Viruses in Patients with Cystic Fibrosis Who Are Receiving Porcine-Derived Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors |