Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-10968 |
| Trade Name | Dose Form | Strength | Identifier |
| Veklury | Powder for injection | 100 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Gilead Sciences (NZ) c/- Grant Thornton New Zealand Limited L4, 152 Fanshawe Street PO Box 1961 Auckland 1140 | 14/10/2021 | Consent given Approval date: 14/9/2023 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| powder for injection | Active | |
| Remdesivir 100mg (approx 5% overfill) | Cambrex Charles City Inc 1205 11th Street Charles City Iowa 50616 UNITED STATES OF AMERICA | |
| Gilead Alberta ULC 1021 Hayter Road Edmonton Alberta TS6 1A1 CANADA | ||
| Excipient | ||
| Betadex | ||
| Hydrochloric acid | ||
| Sodium hydroxide |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Charles River Laboratories Ireland Limited Carrentrila Ballina County Mayo IRELAND |
| Eurofins Biopharma Product Testing Ireland Limited Clogherane Dungarvan County Waterford X35 T628 IRELAND | |
| Eurofins Lancaster Laboratories Inc 2425 New Holland Pike Lancaster Pennsylvania 17601 UNITED STATES OF AMERICA | |
| Gilead Sciences Inc 333 Lakeside Drive Foster City California 94404 UNITED STATES OF AMERICA | |
| Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill Co. Cork IRELAND | |
| Hikma Farmaceutica (Portugal) Lda Estrada do Rio da Mo no. 8, 8A & 8B Fervenca Terrugem - Sintra 2705-906 PORTUGAL | |
| Jubilant HollisterStier LLC 3523 North Regal Street Spokane Washington 99207-5788 UNITED STATES OF AMERICA | |
| Patheon Italia S.p.A Viale G.B. Stucchi, 110 Monza Milan 20900 ITALY | |
| Patheon Manufacturing Services LLC 5900 Martin Luther King Jr Highway Greenville North Carolina 27834 UNITED STATES OF AMERICA | |
| PPD Development 8551 Research Way, Suite 90 Middleton Wisconsin 53562 UNITED STATES OF AMERICA | |
| Manufacture of Final Dose Form | Hikma Farmaceutica (Portugal) Lda Estrada do Rio da Mo no. 8, 8A & 8B Fervenca Terrugem - Sintra 2705-906 PORTUGAL |
| Jubilant HollisterStier LLC 3525 N Regal Street Spokane Washington 99207 UNITED STATES OF AMERICA | |
| Patheon Italia S.p.A Viale G.B. Stucchi, 110 Monza Milan 20900 ITALY | |
| Patheon Manufacturing Services LLC 5900 Martin Luther King Jr Highway Greenville North Carolina 27834 UNITED STATES OF AMERICA | |
| Packing | Hikma Farmaceutica (Portugal) Lda Estrada do Rio da Mo no. 8, 8A & 8B Fervenca Terrugem - Sintra 2705-906 PORTUGAL |
| Patheon Italia S.p.A Viale G.B. Stucchi, 110 Monza Milan 20900 ITALY | |
| Patheon Manufacturing Services LLC 5900 Martin Luther King Jr Highway Greenville North Carolina 27834 UNITED STATES OF AMERICA | |
| Secondary Packaging | AndersonBrecon Inc dba PCI of Illinois 4545 Assembly Drive Rockford Illinois 61109 UNITED STATES OF AMERICA |
| Gilead Sciences Inc 1800 Wheeler Avenue La Verne California 91750 UNITED STATES OF AMERICA | |
| Gilead Sciences Inc 542 Covina Boulevard San Dimas California 91773 UNITED STATES OF AMERICA | |
| Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill Co. Cork IRELAND | |
| Millmount Healthcare Limited Block-7 City North Business Campus Stamullen County Meath K32 YD60 IRELAND | |
| NZ Site of Product Release | Gilead Sciences (NZ) c/- Grant Thornton New Zealand Limited L4, 152 Fanshawe Street Auckland 1010 |
Packaging
| Package | Contents | Shelf Life |
| Vial, glass, Type I clear, an elastomeric closure, and an aluminium overseal with a flip-off cap | 1 dose units | 36 months from date of manufacture stored at or below 30°C 4 hours reconstituted stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) |
Indications
Veklury is indicated for the treatment of coronavirus disease 2019 (COVID-19) in:
- adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) who have pneumonia due to SARS-CoV-2, and who require supplemental oxygen.
- adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 14/10/2021 | New Higher-risk Medicine Application | Abridged new higher-risk medicine containing one or more new active substance | Granted 14/9/2023 | 3/12/2021 |
