Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-9940 |
| Trade Name | Dose Form | Strength | Identifier |
| 4% Articadent DENTAL with Adrenaline (Epinephrine) 1:100,000 | Solution for injection | Dentsply | |
| Sponsor | Application date | Registration situation | Classification |
| Dentsply Sirona (NZ) Limited P O Box 5966 Auckland 1141 | 16/2/2016 | Consent given Approval date: 27/10/2016 | Prescription |
| Reference product: Septanest Solution for injection 40mg/10µg per mL | |||
Composition
| Component | Ingredient | Manufacturer |
| solution for injection | Active | |
| Adrenaline acid tartrate 18.2 µg/mL equivalent to adrenaline 10 micrograms/ml | Cambrex Profarmaco Milano Srl Via Curiel 34 Paullo Milano 20067 ITALY | |
| Articaine hydrochloride 40 mg/mL | Zentiva Private Limited Plot No 3501 to 3515 6301 to 6313 & 16.00 meter, road/c, GIDC Estate District Bharuch, Ankleshwar Gujarat 393 002 INDIA | |
| Excipient | ||
| Hydrochloric acid | ||
| Sodium chloride | ||
| Sodium hydroxide | ||
| Sodium metabisulfite | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Laboratorios INIBSA, S.A. Ctra. Sabadell a Granollers, km 14,5 Llica de Vall 08185 Barcelona SPAIN |
| Manufacture of Final Dose Form | Laboratorios INIBSA, S.A. Ctra. Sabadell a Granollers, km 14,5 Llica de Vall 08185 Barcelona SPAIN |
| Packing | Laboratorios INIBSA, S.A. Ctra. Sabadell a Granollers, km 14,5 Llica de Vall 08185 Barcelona SPAIN |
| NZ Site of Product Release | Agility Logistics Ltd 9 Richard Pearse Drive Mangere Auckland |
Packaging
| Package | Contents | Shelf Life |
| Cartridge, glass, Type 1, clear, with self-aspirating bromobutyl plunger and aluminium cap, 2.2 mL | 50 dose units | 2 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 Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 5/10/2021 | Self-Assessable Change Notification | Labelling - Grade 1 (Self assessable) | Notified | 2/11/2021 | |
| 16/2/2016 | New Intermediate-risk Medicine Application | Abridged new intermediate-risk prescription medicine | Granted 27/10/2016 | 24/2/2016 |
