Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.
This guideline describes the information on the clinical development to be documented when an application for a marketing authorisation for a medicinal product is made for the treatment of chronic primary immune thrombocytopenia. The purpose of this guidance is to provide a harmonised regulatory approach that will lead to a consistent assessment of products by regulators and set clear standards for industry.
| Download document | Draft guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia |
|---|---|
| Reference number | EMA/CHMP/153191/2013 |
| Status | draft: consultation open |
| First published | 20/03/2013 |
| Last updated | 20/03/2013 |
| Consultation start date | 20/03/2013 |
| Consultation end date | 31/08/2013 |
| Email address for submissions | oncwpsecretariat@ema.europa.eu |