An Open-label, Multicenter, Post-Marketing Requirement (PMR) Study to Investigate the Safety, Tolerability and Efficacy of Octaplas in the Management of Pediatric Patients Who Require Replacement of Multiple Coagulation Factors
Latest Information Update: 07 Nov 2021
At a glance
- Drugs Plasma (Primary)
- Indications Blood coagulation disorders
- Focus Adverse reactions
- Sponsors Octapharma
- 29 Mar 2021 According to a Food and Drug Administration media release, the U.S. Food and Drug Administration (FDA) has approved a supplemental Biological License Application which resulted in new product labeling for Octaplas, Pooled Plasma (Human), Solvent/Detergent (S/D) Treated Solution for Intravenous Infusion. The Octaplas labeling now provides the results of two post-marketing studies (LAS-212, LAS-213).
- 29 Mar 2021 According to a Food and Drug Administration media release, results from this study were published in the Frontiers in Pediatrics.
- 22 May 2019 Results presented in an Octapharma media release.