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PRILOTEKAL prilocaine hydrochloride 100 mg/5 mL solution for injection ampoule, B Braun Australia Pty Ltd , CON-1083
Product name
PRILOTEKAL prilocaine hydrochloride 100 mg/5 mL solution for injection ampoule
Sponsor name
B Braun Australia Pty Ltd
Consent start
Consent no.
CON-1083
Duration
The consent is effective from 16 March 2023 until 16 March 2028.
Standard
pH requirements of Prilocaine Injection (British Pharmacopoeia 2023) or Prilocaine Hydrochloride Injection (United States Pharmacopeia 2023). of British Pharmacopoeia
Non-compliance with standard
The product does not necessarily conform because: • It has a pH in the range 4.0
– 6.0. • The Prilocaine Injection (British Pharmacopoeia 2023) monograph
requires Acidity: pH 5.0 to 7.0; • The Prilocaine Hydrochloride Injection
(United States Pharmacopeia 2023) monograph requires pH ?791?: 6.0–7.0.
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Prescription medicines