Merck & Co., Inc. — Ristaben EMA EPAR public assessment report (EMEA/H/C/001234, 2010)
Merck & Co., Inc. · 2010 · EMA EPAR public assessment report · company profile →
Report summary
The CHMP granted a positive opinion for Ristaben (sitagliptin) Marketing Authorisation on December 17, 2009, based on an informed consent application by Merck Sharp & Dohme Ltd. This means Ristaben shares the identical quality, safety, and efficacy profile of the already approved Januvia. Ristaben is indicated for improving glycaemic control in type 2 diabetes mellitus, usable as monotherapy, dual oral therapy, triple oral therapy, or as an add-on to insulin.
Key findings — cited to the page
| Age restriction | below 18 years years | Ristaben · p.5 |
| Marketing Authorisation date for Tesavel | 11 January 2008 | Tesavel · EU · p.3 |
| Marketing Authorisation application submission date | 2 October 2009 | Ristaben · EU · p.3 |
| CHMP agreement on centralised procedure eligibility | 23 July 2009 | EU · p.3 |
| Marketing Authorisation date for Januvia | 21 March 2007 | Januvia · EU · p.3 |
| Marketing Authorisation date for Xelevia | 21 March 2007 | Xelevia · EU · p.3 |
| CHMP positive opinion date for Ristaben | 17 December 2009 | Ristaben · EU · p.4 |
| HbA1c reduction from baseline | reduction | Ristaben · p.5 |
| HbA1c reduction from baseline | reduction | Ristaben · p.5 |
Source: Merck & Co., Inc. ↗ · 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 Metabolic library →