Merck & Co., Inc. — Ristfor EMA EPAR public assessment report (EMEA/H/C/001235, 2010)
Merck & Co., Inc. · 2010 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) assessed Ristfor (sitagliptin/metformin hydrochloride) for marketing authorization. This 'informed consent' application leveraged the established quality, safety, and efficacy of the already approved Janumet, considering Ristfor identical. On December 17, 2009, the CHMP issued a positive opinion, recommending Ristfor's approval for treating type 2 diabetes mellitus in various combination therapies.
Key findings — cited to the page
| Marketing Authorisation application submission date | 2 October 2009 | Ristfor · Europe · p.3 |
| CHMP eligibility agreement date | 27 July 2009 | Ristfor · Europe · p.3 |
| Legal basis for application | Article 10(c) of Directive 2001/83/EC | Ristfor · Europe · p.3 |
| Marketing Authorisation date for Janumet | 16 July 2008 | Janumet · Europe · p.3 |
| Marketing Authorisation date for Velmetia and Efficib | 16 July 2008 | Velmetia, Efficib · Europe · p.3 |
| Procedure start date | 18 October 2009 | Ristfor · Europe · p.4 |
| CHMP positive opinion date | 17 December 2009 | Ristfor · Europe · p.4 |
| Letter of undertaking submission date | 11 December 2009 | Ristfor · Europe · p.4 |
| Ristfor strengths | 50 mg/850 mg and 50 mg/1000 mg | Ristfor · p.4 |
| Nausea incidence | most common | Ristfor · p.5 |
| Headache incidence (sitagliptin monotherapy) | >0.2% | sitagliptin · p.5 |
| Hypoglycaemia incidence (sitagliptin monotherapy) | >0.2% | sitagliptin · 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 →