Servier — Oncaspar EMA EPAR public assessment report (EMEA/H/C/003789, 2016)
Servier · 2016 · EMA EPAR public assessment report
Report summary
This EMA public assessment report details the successful marketing authorization application for Oncaspar (pegaspargase) for Acute Lymphoblastic Leukaemia (ALL). The report covers the comprehensive scientific assessment, including quality, non-clinical, and clinical data, which led to a positive opinion for granting marketing authorization. It also provides background on ALL and the therapeutic role of pegaspargase.
Key findings — cited to the page
| Marketing Authorisation date | 1 February 1994 | Oncaspar · United States · p.7 |
| Marketing Authorisation date | 15 November 2005 | Oncaspar · Kazakhstan · p.8 |
| Marketing Authorisation date | 1 August 2005 | Oncaspar · Ukraine · p.8 |
| Marketing Authorisation date | 1 July 2005 | Oncaspar · Belarus · p.8 |
| Marketing Authorisation date | 6 October 2004 | Oncaspar · Argentina · p.8 |
| Procedure start date | 23 July 2014 | · p.8 |
| Positive opinion for granting Marketing Authorisation | 26 November 2015 | Oncaspar · p.9 |
| Incidence of ALL in children aged 2-3 years | >90 per million per year | · p.9 |
| Incidence of ALL in children aged 8 years | 30 per million | · p.9 |
| Peak incidence of ALL in adults | 2 per 100,000 | · p.9 |
| Estimated incidence of ALL | 1.28 per 100,000 persons | EU · p.9 |
| Marketing Authorisation date | 10 December 2008 | Oncaspar · Poland · p.7 |
Source: Servier ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →