Zynrelef

bupivacaine / meloxicam

Table of contents

Opinion

On 23 July 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zynrelef, intended for the treatment of post-operative pain. The applicant for this medicinal product is Heron Therapeutics, B.V.

Zynrelef will be available as prolonged-release wound solutions (60 mg / 1.8 mg, 200 mg / 6 mg and 400 mg / 12 mg). The active substances of Zynrelef are bupivacaine and meloxicam, local anaesthesia medicines (amides). Bupivacaine works as a local anaesthetic and meloxicam enhances the efficacy of bupivacaine.  

The benefits with Zynrelef are its ability to relieve post-operative pain. The most common side effect was dizziness.

The full indication is:

Zynrelef is indicated for treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults (see section 5.1).

It is proposed that Zynrelef is administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity.

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.

Key facts

Name
Zynrelef
Agency product number
EMEA/H/C/005205
International non-proprietary name (INN) or common name
  • bupivacaine / meloxicam
Active substance
  • bupivacaine
  • meloxicam
Therapeutic area
Pain, Postoperative
Date opinion adopted
23/07/2020
Company name
Heron Therapeutics, B.V.
Status
Positive
Application type
Initial authorisation

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