Prialt

RSS

ziconotide

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 21/09/2018

Authorisation details

Product details
Name
Prialt
Agency product number
EMEA/H/C/000551
Active substance
ziconotide
International non-proprietary name (INN) or common name
ziconotide
Therapeutic area (MeSH)
  • Injections, Spinal
  • Pain
Anatomical therapeutic chemical (ATC) code
N02BG08
Orphan

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.

Publication details
Marketing-authorisation holder
RIEMSER Pharma GmbH
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
21/02/2005
Contact address
An derWiek 7
17493 Greifswald-Insel Riems
Germany

Product information

02/07/2018 Prialt - EMEA/H/C/000551 - T/0056

Contents

  • 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.

Pharmacotherapeutic group

ANALGESICS

Therapeutic indication

Ziconotide is indicated for the treatment of severe, chronic pain in patients who require intrathecal (IT) analgesia.

Assessment history

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