PRIALT Solution for infusion Ref.[9283] Active ingredients: Ziconotide

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: RIEMSER Pharma GmbH, An der Wiek 7, 17493, Greifswald-Insel Riems, Germany

Product name and form

Prialt 25 micrograms/ml solution for infusion.

Pharmaceutical Form

Solution for infusion (infusion).

Clear, colourless solution.

Qualitative and quantitative composition

One ml solution contains 25 μg ziconotide (as acetate).

Each 20 ml vial contains 500 μg ziconotide (as acetate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ziconotide

Ziconotide is a synthetic analogue of a ω-conopeptide, MVIIA, found in the venom of the Conus magus marine snail. It is an N-type calcium channel blocker (NCCB). In binding to these neuronal NCCs ziconotide inhibits the voltage sensitive calcium current into primary nociceptive afferents terminating in the superficial layers of the dorsal horn of the spinal cord.

List of Excipients

Methionine
Sodium chloride
Water for injections
Hydrochloric acid (pH adjuster)
Sodium hydroxide (pH adjuster)

Pack sizes and marketing

Type I glass vials with butyl rubber stoppers coated with fluorinated polymer.

Each vial contains 20 ml solution for infusion.

One vial per carton.

Marketing authorization holder

RIEMSER Pharma GmbH, An der Wiek 7, 17493, Greifswald-Insel Riems, Germany

Marketing authorization dates and numbers

EU/1/04/302/004 – 20 ml solution for infusion

Date of first authorisation: 21 February 2005
Date of latest renewal: 18 September 2014

Drugs

Drug Countries
PRIALT Austria, Cyprus, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

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