Regulatory PathRegulatory requirements compared

Active substance

Levobupivacaine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
CHIROCAINEEQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 7.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionPURDUE PHARMA LPDiscontinued5 Aug 1999

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
LEVOBUPIVACAINE 0.625 MG/ML SOLUTION FOR INFUSIONPL 08828/0248FRESENIUS KABI LIMITEDPOM
LEVOBUPIVACAINE 1.25 MG/ML SOLUTION FOR INFUSIONPL 08828/0249FRESENIUS KABI LIMITEDPOM
LEVOBUPIVACAINE 1.25 MG/ML SOLUTION FOR INFUSIONPL 51338/0005ALTAN PHARMACEUTICALS SAPOM
LEVOBUPIVACAINE 2.5 MG/ML SOLUTION FOR INJECTION/INFUSIONPL 05448/0024ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI SPAPOM
LEVOBUPIVACAINE 2.5 MG/ML SOLUTION FOR INJECTION/INFUSIONPL 08828/0250FRESENIUS KABI LIMITEDPOM
LEVOBUPIVACAINE 2.5 MG/ML SOLUTION FOR INJECTION/INFUSIONPL 51338/0002ALTAN PHARMACEUTICALS SAPOM
LEVOBUPIVACAINE 5 MG/ML SOLUTION FOR INJECTION/INFUSIONPL 05448/0025ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI SPAPOM
LEVOBUPIVACAINE 5 MG/ML SOLUTION FOR INJECTION/INFUSIONPL 08828/0251FRESENIUS KABI LIMITEDPOM
LEVOBUPIVACAINE 5 MG/ML SOLUTION FOR INJECTION/INFUSIONPL 51338/0003ALTAN PHARMACEUTICALS SAPOM
LEVOBUPIVACAINE 7.5 MG/ML SOLUTION FOR INJECTION/INFUSIONPL 05448/0026ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI SPAPOM
LEVOBUPIVACAINE 7.5 MG/ML SOLUTION FOR INJECTION/INFUSIONPL 08828/0252FRESENIUS KABI LIMITEDPOM
LEVOBUPIVACAINE 7.5 MG/ML SOLUTION FOR INJECTION/INFUSIONPL 51338/0004ALTAN PHARMACEUTICALS SAPOM

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.