Dzuveo

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Questions & Answers

On 26 April 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Dzuveo, intended for the treatment of pain. The applicant for this medicinal product is FGK Representative Service GmbH.

Dzuveo will be available as 30-microgram sublingual tablets. The active substance of Dzuveo is sufentanil, an opioid (ATC code: N01AH03) which produces analgesia by activating μ-opioid receptors primarily within the central nervous system.

The benefits with Dzuveo are its ability to reduce pain. The most common side effects are nausea, vomiting and pyrexia.

Dzuveo is a hybrid medicine* of Sufenta which has been authorised in the EU since 1978. Dzuveo contains the same active substance as Sufenta, but is given in a different way.

The full indication is: "Dzuveo is indicated for the management of acute moderate to severe pain in adult patients".

Dzuveo should only be administered by healthcare professionals who are experienced in the management of opioid therapy.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

*Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.

Name Language First published Last updated
CHMP summary of positive opinion for Dzuveo (English only) 2018-04-27  

Key facts

Product details for Dzuveo
NameDzuveo
INN or common name

sufentanil

Therapeutic area Pain
Active substance

sufentanil citrate

Date opinion adopted26/04/2018
Company name

FGK Representative Service GmbH

StatusPositive
Application typeInitial authorisation