Zentiva k s — Leflunomide Zentiva (previously Leflunomide Winthrop) EMA EPAR public assessment report (EMEA/H/C/001129, 2010)
Zentiva k s · 2010 · EMA EPAR public assessment report
Report summary
The European Medicines Agency (EMA) assessed Leflunomide Winthrop (now Leflunomide Zentiva), an informed consent application by Sanofi-Aventis Deutschland GmbH, referencing the established drug Arava. The CHMP issued a positive opinion on October 22, 2009, for treating active rheumatoid arthritis and psoriatic arthritis in adults. The assessment confirmed that Leflunomide Winthrop possesses an identical quality, safety, and efficacy profile to Arava. A comprehensive risk management plan addresses potential adverse effects including hepatic reactions, blood cytopenia, severe skin reactions, infections, interstitial lung disease, teratogenicity, hypertension, and interactions with other DMARDs.
Key findings — cited to the page
| Application submission date | 4 February 2009 | Leflunomide Winthrop · EU · p.3 |
| CHMP agreement on eligibility to centralised procedure | 25 September 2008 | EU · p.3 |
| CHMP positive opinion date | 22 October 2009 | Leflunomide Winthrop · EU · p.4 |
| Recommended maintenance dose for rheumatoid arthritis | 10 to 20 mg once daily | · p.5 |
| Recommended maintenance dose for psoriatic arthritis | 20 mg once daily | · p.5 |
| Psoriatic arthritis treatment response rate (Leflunomide) | 59 % | · p.6 |
| Psoriatic arthritis treatment response rate (placebo) | 30 % | · p.6 |
Source: Zentiva k s ↗ · 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 Immunology library →