DZUVEO Sublingual tablet Ref.[49919] Active ingredients: Sufentanil

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Laboratoire Aguettant, 1, rue Alexander Fleming, 69007 Lyon, France

Product name and form

Dzuveo 30 micrograms sublingual tablet.

Pharmaceutical Form

Sublingual tablet.

Blue-coloured flat-faced tablet with round edges and a diameter of 3 mm.

Qualitative and quantitative composition

Each sublingual tablet contains 30 micrograms of sufentanil (as citrate).

For the full list of excipients, see section 6.1.

Active Ingredient

Sufentanil is a synthetic, potent opioid with highly selective binding to μ-opioid receptors. Sufentanil acts as a full agonist in μ-opioid receptors. Sufentanil does not induce histamine release.

List of Excipients

Mannitol E421
Calcium hydrogen phosphate
Hypromellose
Croscarmellose sodium
Indigo carmine E132
Stearic acid
Magnesium stearate

Pack sizes and marketing

Dzuveo is packaged in a polypropylene single-dose applicator, which is packaged in a polyester film/LDPE/aluminium foil/LDPE sachet with an oxygen absorber.

Dzuveo will be available in cartons of 5 and 10. Not all pack sizes may be marketed.

Marketing authorization holder

Laboratoire Aguettant, 1, rue Alexander Fleming, 69007 Lyon, France

Marketing authorization dates and numbers

EU/1/18/1284/001
EU/1/18/1284/002

Date of first authorisation: 25 June 2018
Date of latest renewal: 24 March 2023

Drugs

Drug Countries
DZUVEO Austria, Estonia, Croatia, Ireland, Lithuania, Poland

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