The current guideline CHMP/EWP/240/95 Rev. 1 contains a section describing the legal basis applicable to fixed dose combination (FDC) product marketing authorisation application (MAA).
Document details
| Download document | Concept paper on the need for revision of note for guidance on clinical investigation of medicinal products for the treatment of cardiac failure |
|---|---|
| Reference number | EMA/CHMP/87576/2013 |
| Status | draft: consultation open |
| First published | 01/03/2013 |
| Last updated | 01/03/2013 |
| Consultation start date | 01/03/2013 |
| Consultation end date | 31/05/2013 |
| Email address for submissions | cvswpsecretariat@ema.europa.eu |