Device Dossier
Cartridge-accepting autoinjector, mechanical
Device Dossier for Cartridge-accepting autoinjector, mechanical (Cartridge-accepting autoinjector, mechanical, Class IIa, sponsor Sandoz). ARTG record,…
- GMDN category: Cartridge-accepting autoinjector, mechanical
- Sponsor: Sandoz
Intended purpose
The device is intended for subcutaneous (under the skin) injection of a daily dose of Omnitrope® (rhGH drug). It is intended for patients (paediatric patients and adults) treated for growth disturbances and growth hormone deficiencies. The injection can be performed by the patient him/herself or also by a lay caregiver in case of small children or patients unable to perform the injection themselves or by healthcare professionals (HCPs). The device is a multi-dose, reusable needle- based injection system with automated functions to be used with the liquid formulation Omnitrope® in a standard 1.5 mL disposable pre-assembled cartridge.