LIDOCAINE AGUETTANT (Lidocaine hydrochloride) - Anaesthesia

The Committee deems that the clinical benefit of LIDOCAINE AGUETTANT 10 and 20 mg/mL solution for injection in pre-filled syringe is substantial for local anaesthesia in the event of intravenous use to prevent injection-related pain in children from 12 years of age (only for the 10 mg/mL strength) and adults.

The Committee issues a favourable opinion for inclusion of LIDOCAINE AGUETTANT 10 and 20 mg/mL solution for injection in pre-filled syringe in the list of covered drugs for inpatients approved for use for local anaesthesia in the event of intravenous use to prevent injection-related pain in children from 12 years of age (only for the 10 mg/mL strength) and adults and at the MA dosages.

Local anaesthesia in the event of intravenous use to prevent injection-related pain.

Considering:

• limited data from meta-analyses having suggested a moderate efficacy of lidocaine IV compared to placebo on the incidence of pain related to the injection of propofol, taken into account for LIDOCAINE AGUETTANT 10 mg/mL PRESERVATIVE-FREE solution for injection,
• the identified medical need to have access to lidocaine to prevent pain related to the intravenous injection of medicinal products, particularly propofol, in accordance with good clinical practice,

the Committee deems that LIDOCAINE AGUETTANT 10 and 20 mg/mL solution for injection in pre-filled syringe provides no clinical added value (CAV V) compared with LIDOCAINE AGUETTANT 10 mg/mL PRESERVATIVE-FREE solution for injection.