Is Ziconotide approved by the US FDA?

Drugs@FDA lists 2 application product lines for Ziconotide, including PRIALT (Prescription); PRIALT (Discontinued).

Is Ziconotide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ziconotide: Prialt.

Active substance

Ziconotide

US FDA 2
EMA 1

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
PRIALT	500MCG/20ML (25MCG/ML); 100MCG/1ML (100MCG/ML); 500MCG/5ML (100MCG/ML)	injectable · intrathecal	ESTEVE	Prescription	28 Dec 2004
PRIALT	200MCG/2ML (100MCG/ML)	injectable · intrathecal	ESTEVE	Discontinued	28 Dec 2004

EMA European Union — centrally authorised medicines

Prialt Esteve Pharmaceuticals GmbH · Authorised · authorised 21 Feb 2005 · ATC N02BG08

Therapeutic indication (EMA)

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

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.