Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-9940
Trade NameDose FormStrengthIdentifier
4% Articadent DENTAL with Adrenaline (Epinephrine) 1:100,000Solution for injectionDentsply
SponsorApplication dateRegistration situationClassification
Dentsply Sirona (NZ) Limited
c/o Lowndes Jordan
Level 15, PWC Tower
188 Quay Street
Auckland 1010
16/2/2016Consent given
Approval date: 27/10/2016
Prescription
Reference product: Septanest Solution for injection 40mg/10µg per mL

Composition

ComponentIngredientManufacturer
solution for injectionActive 
 Adrenaline acid tartrate 18.2 µg/mL (equivalent to adrenaline 10 micrograms/ml)Cambrex Profarmaco Milano Srl
Via Curiel 34
Paullo
Milano 20067
Italy
  Boehringer Ingelheim Pharma GmbH & Co KG
Binger Strasse 173
Ingelheim am Rhein 55216
Germany
 Articaine hydrochloride 40 mg/mLSanofi India Limited
3501, 3503-15, 6310 B014 GIDC Estate
District Bharuch
Ankleshwar
Gujarat 393 002
India
 Excipient 
 Hydrochloric acid
 Sodium chloride
 Sodium hydroxide
 Sodium metabisulfite
 Water for injection

Production

Manufacturing stepManufacturer
Finished Product TestingLaboratorios INIBSA, S.A.
Ctra. Sabadell a Granollers, km 14,5
Llica de Vall 08185
Barcelona
Spain
Manufacture of Final Dose FormLaboratorios INIBSA, S.A.
Ctra. Sabadell a Granollers, km 14,5
Llica de Vall 08185
Barcelona
Spain
PackingLaboratorios INIBSA, S.A.
Ctra. Sabadell a Granollers, km 14,5
Llica de Vall 08185
Barcelona
Spain
NZ Site of Product ReleaseAgility Logistics Ltd
9 Richard Pearse Drive
Mangere
Auckland

Packaging

PackageContentsShelf Life
Cartridge, glass, Type 1, clear, with self-aspirating bromobutyl plunger and aluminium cap, 2.2 mL50 dose units2 years from date of manufacture stored at or below 25°C protect from light. Do not freeze

Indications

Indicated for local or regional anaesthesia for both simple and complex dental procedures in adults, adolescents and children 4 years of age and older.

Indicated only for dental procedures.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
19/11/2018Changed Medicine NotificationActive ingredient manufacturing process - Grade 1; Data sheet - reformatting only; Labelling - Grade 1; Sponsor; Product nameGranted 7/2/20195/2/2019 
16/2/2016New Intermediate-risk Medicine ApplicationAbridged new intermediate-risk prescription medicineGranted 27/10/201624/2/2016 
0 1 2 4 5 6 7 9 [ /