Regulatory PathRegulatory requirements compared

Active substances

Bupivacaine + Meloxicam

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
ZYNRELEF KIT200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML); 400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)solution, extended release · periarticularHERON THERAPS INCPrescription12 May 2021
ZYNRELEF KIT60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML); 300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)solution, extended release · periarticularHERON THERAPS INCDiscontinued12 May 2021

EMA European Union — centrally authorised medicines

Zynrelef Heron Therapeutics, B.V. · Withdrawn · authorised 24 Sep 2020 · ATC N01B

Therapeutic indication (EMA)

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

Components

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.