This is a summary of the European public assessment report (EPAR) for Prialt. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Prialt.
Prialt : EPAR - Summary for the public (PDF/72.59 KB)
First published: 19/11/2007
Last updated: 12/03/2014
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
RIEMSER Pharma GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
02/07/2018 Prialt - EMEA/H/C/000551 - T/0056
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Ziconotide is indicated for the treatment of severe, chronic pain in patients who require intrathecal (IT) analgesia.