Palivizumab: Synagis

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.

{m} Entries

Phase
Study Indication or Disease
Study Name
M12-420 AbbVie_IU_icons_outlined_v3 Respiratory Syncytial Virus Phase 3 Multi-center, Open-label, Uncontrolled Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions
W00-353 AbbVie_IU_icons_outlined_v3 Respiratory Syncytial Virus Phase 4 A Phase IV, Multicenter, Comparative Study in Preterm Children Who Previously Received Synagis Prophylaxis Versus Preterm Children Without RSV Prophylaxis: Development of Reactive Airway Disease
W10-664 AbbVie_IU_icons_outlined_v3 Respiratory Syncytial Virus Phase 2 A Prospective, Muticenter, Open-Label, Non-Comparative Study of Safety and Efficacy of Synagis® in Children at High Risk of Severe Respiratory Syncytial Virus Infection in the Russian Federation
M02-489 AbbVie_IU_icons_outlined_v3 Respiratory Syncytial Virus Phase 4 A Phase IV, Case-Matched, Cohort Surveillance Study in Preterm Children Who Receive SYNAGIS® Prophylaxis in the First Year of Life Versus Preterm Children Without RSV Prophylaxis: Incidence of RSV Hospitalization and Assessment of Disease Severity in the Season Following Prophylaxis
P13-203 AbbVie_IU_icons_outlined_v3 Respiratory Syncytial Virus PMOS Post-Marketing Surveillance of Synagis in Korean Pediatric Patients Under the "New Drug Re-Examination"
P10-129 AbbVie_IU_icons_outlined_v3 Respiratory Syncytial Virus PMOS A One-Year Observational Study of Palivizumab in Infants at Risk for Respiratory Syncytial Virus Infection in Latin America
P14-296 AbbVie_IU_icons_outlined_v3 Respiratory Syncytial Virus PMOS Synagis® liquid 50 mg, 100 mg for Intramuscular Injection: Special Investigation in Immunocompromised Children with Synagis®
P10-410 AbbVie_IU_icons_outlined_v3 Respiratory Syncytial Virus PMOS Prospective, non-interventional observation study for the use of palivizumab in highrisk children in Germany
P14-579 AbbVie_IU_icons_outlined_v3 Respiratory Syncytial Virus PMOS Prospective, Multi-Center, Observational Program to Assess RSV Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis in Routine Clinical Setting in the Russian Federation
M15-539 AbbVie_IU_icons_outlined_v3 Respiratory Syncytial Virus Phase 3 A Prospective, International, Multicenter, Open Label, Non-Controlled Study of Safety and Effectiveness of Palivizumab, in Children at High Risk of Severe Respiratory Syncytial Virus