Eli Lilly and Company — Duloxetine Lilly EMA EPAR public assessment report (EMEA/H/C/004000, 2014)
Eli Lilly and Company · 2014 · EMA EPAR public assessment report · company profile →
Report summary
Eli Lilly Nederland B.V. submitted an informed consent application to the EMA for Duloxetine Lilly, referencing the existing Cymbalta marketing authorization. The CHMP issued a positive opinion on October 23, 2014, for the treatment of major depressive disorder, diabetic peripheral neuropathic pain, and generalized anxiety disorder in adults. Duloxetine Lilly is identical to Cymbalta in terms of quality, safety, and efficacy.
Key findings — cited to the page
| Cymbalta Pregnancy Registry Final Report Submission Date | Q4 2016 | Cymbalta Pregnancy Registry · p.8 |
| GPRD Feasibility Assessment for Suicidality Study Submission Date | Q4 2014 | Study F1J-MC-B035 General Practice Research Database (GPRD) · p.9 |
| Benefit-Risk Balance Conclusion | favourable | Duloxetine Lilly · p.11 |
| Marketing Authorisation Recommendation | granting of the marketing authorisation | Duloxetine Lilly · p.12 |
| Marketing Authorisation Application Submission Date | 7 May 2014 | Duloxetine Lilly · European Union · p.4 |
| Indication | Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Duloxetine Lilly is indicated in adults. | Duloxetine Lilly · European Union · p.4 |
| Legal Basis for Application | Article 10(c) of Directive 2001/83/EC | Duloxetine Lilly · European Union · p.4 |
| Cymbalta Community Marketing Authorisation Date | 17 December 2004 | Cymbalta · European Union · p.4 |
| CHMP Positive Opinion Date | 23 October 2014 | Duloxetine Lilly · European Union · p.5 |
| Approved Indication | Treatment of major depressive disorder. Treatment of diabetic peripheral neuropathic pain. Treatment of generalised anxiety disorder. Duloxetine Lilly is indicated in adults. | Duloxetine Lilly · European Union · p.6 |
| Important Identified Risks | Hepatic risks, Suicidality, Hyperglycaemia, Stevens-Johnson Syndrome, Gastrointestinal tract bleeding | Duloxetine Lilly · p.8 |
| Important Potential Risks | Cardiovascular events including those with concomitant use of NSAIDs (including myocardial infarction, heart failure, and stroke), Upper gastrointestinal tract bleeding events with concomitant use of NSAIDs, Renal failure | Duloxetine Lilly · p.8 |
Source: Eli Lilly and Company ↗ · 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 Psychiatry library →