Regulatory PathRegulatory requirements compared

Active substances

Articaine + Epinephrine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Orabloc40,18.2 mg/ml,mg/mlSolution for injection in cartridge · Dental use50 CartridgeSAR 99.40Generic · PrescriptionPIERREL PHARMA S.R.L.Valid
Orabloc40,9.1 mg/ml,mg/mlSolution for injection in cartridge · Dental use50 CartridgeSAR 99.40Generic · PrescriptionPIERREL PHARMA S.R.L.Valid
SEPTANEST N 1-200000 DENTAL CARTRIDGE0.005,40 mg,mgSolution for injection · Dental use50 CartridgeSAR 104.35NCE · PrescriptionSEPTODENTValid
SEPTANEST SP 1-100000 DENTAL CARTRIDGE0.01,40 mg,mgSolution for injection · Dental use50 CartridgeSAR 104.35NCE · PrescriptionSEPTODENTValid
Indications — CHI Daman Drug Formulary

ANESTHESIA

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

ProductStrengthForm · routeApplicantStatusFirst approved
SEPTOCAINE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML); 4%; EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)injectable · injectionDEPROCOPrescription3 Apr 2000
SEPTOCAINE4%;EQ 0.0085MG BASE/1.7ML (4%;EQ 0.005MG BASE/ML)injectable · injectionDEPROCOPrescription30 Mar 2006
ORABLOC4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML); 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML)injectable · injectionPIERRELPrescription26 Feb 2010
ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)injectable · injectionHOSPIRADiscontinued18 Jun 2010
ULTACAN FORTE4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML)injectable · injectionHANSAMED INCDiscontinued11 Jul 2017
ULTACAN4%;EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)injectable · injectionHANSAMED INCDiscontinued11 Jul 2017

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
4% ASTRACAINE DENTAL WITH EPINEPHRINE 1:200,000 (0.005MG/ML)022484890.005 MG / ML; 40 MG / MLSOLUTION · BLOCK/INFILTRATIONDENTSPLY CANADA LIMITED
4% ASTRACAINE DENTAL WITH EPINEPHRINE FORTE 1:100,000 (0.01MG/ML)0224848840 MG / ML; 0.01 MG / MLSOLUTION · BLOCK/INFILTRATIONDENTSPLY CANADA LIMITED
ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION0233953640 MG / ML; 0.009 MG / MLSOLUTION · BLOCK/INFILTRATIONPIERREL S.P.A.
ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION023395440.018 MG / ML; 40 MG / MLSOLUTION · BLOCK/INFILTRATIONPIERREL S.P.A.
ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION - N0256198040 MG / ML; 0.005 MG / MLSOLUTION · BLOCK/INFILTRATIONSEPTODONT
ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION - SP0256199940 MG / ML; 0.01 MG / MLSOLUTION · BLOCK/INFILTRATIONSEPTODONT
ORABLOC 1:100,0000236191440 MG / ML; 0.018 MG / MLSOLUTION · BLOCK/INFILTRATIONPIERREL S.P.A.
ORABLOC 1:200,000023619060.009 MG / ML; 40 MG / MLSOLUTION · BLOCK/INFILTRATIONPIERREL S.P.A.
POSICAINE N0238131140 MG / ML; 0.005 MG / MLSOLUTION · BLOCK/INFILTRATIONNOVOCOL PHARMACEUTICAL OF CANADA INC
POSICAINE SP023813380.01 MG / ML; 40 MG / MLSOLUTION · BLOCK/INFILTRATIONNOVOCOL PHARMACEUTICAL OF CANADA INC
SEPTANEST N021233710.005 MG / ML; 40 MG / MLSOLUTION · BLOCK/INFILTRATIONSEPTODONT
SEPTANEST SP021233980.01 MG / ML; 40 MG / MLSOLUTION · BLOCK/INFILTRATIONSEPTODONT
ULTRACAINE D-S FORTE INJECTION019885570.01 MG / ML; 40 MG / MLSOLUTION · BLOCK/INFILTRATIONHANSAMED LIMITED
ULTRACAINE D-S INJECTION019885305 MCG / ML; 40 MG / MLSOLUTION · BLOCK/INFILTRATIONHANSAMED LIMITED

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.