Revised: 31 May 2019
Medicines
Medsafe Product Detail |  | |
|---|---|---|
| File ref: TT50-9953 |
| Trade Name | Dose Form | Strength | Identifier |
| Azacitidine Dr Reddy's | Powder for injection | 100 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Dr Reddy's New Zealand Limited 82 Totara Cresent Lower Hutt 5011 | 24/3/2016 | Consent given Approval date: 15/2/2018 Notification date: 28/9/2018 | Prescription |
| Reference product: Vidaza Powder for injection 100 mg | |||
Composition
| Component | Ingredient | Manufacturer |
| powder for injection | Active | |
| Azacitidine 100mg | Dr Reddy's Laboratories Limited CTO Unit-I, Plot Nos. 137, 138, 145 & 146 Sri Venkateswara Co-Operative Industrial Estate Bollaram Village, Jinnaram Mandal Sangareddy District, Telangana 502 325 INDIA | |
| Excipient | ||
| Mannitol |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Dr Reddy's Laboratories Limited Formulations Unit VII, Plot No. P1 to P9, Phase - III, Duvvada, VSEZ Visakhapatnam Andhra Pradesh 530046 INDIA |
| Manufacture of Final Dose Form | Dr Reddy's Laboratories Limited Formulations Unit VII, Plot No. P1 to P9, Phase - III, Duvvada, VSEZ Visakhapatnam Andhra Pradesh 530046 INDIA |
| Packing | Dr Reddy's Laboratories Limited Formulations Unit VII, Plot No. P1 to P9, Phase - III, Duvvada, VSEZ Visakhapatnam Andhra Pradesh 530046 INDIA |
| NZ Site of Product Release | DHL Supply Chain (New Zealand) Ltd 22 Airpark Drive Mangere Auckland 2140 |
Packaging
| Package | Contents | Shelf Life |
| Vial, glass, Type 1 (USP) clear (30 mL capacity), with a grey bromobutyl rubber stopper & aluminium flip-off seal | 1 dose units | 36 months from date of manufacture stored at or below 25°C 1 hours reconstituted stored at or below 25°C 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze). When reconstituted with refrigerated WFI. 22 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze). When reconstituted with refrigerated WFI. |
Indications
Azacitidine is indicated for the treatment of patients with intermediate-2 and high-risk Myelodysplastic Syndromes (MDS) according to the International Prognostic Scoring System (IPSS), Chronic Myelomonocytic Leukaemia (CMMoL [10-29 percent marrow blasts without Myeloproliferative Disorder]), and Acute Myeloid Leukaemia (AML) with 20-30 percent blasts and multi-lineage dysplasia, according to World Health Organisation Classification (WHO), in whom allogenic stem cell transplantation is not indicated.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 26/10/2022 | CMN 24(5) | Active ingredient manufacturing process - Grade 3 | Granted 23/3/2023 | 3/11/2022 | |
| 24/3/2016 | New Intermediate-risk Medicine Application | Abridged new intermediate-risk prescription medicine | Granted 15/2/2018 | 28/4/2016 |
