Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-10968
Trade NameDose FormStrengthIdentifier
VekluryPowder for injection100 mg
SponsorApplication dateRegistration situationClassification
Gilead Sciences (NZ)
c/- Grant Thornton New Zealand Limited
L4, 152 Fanshawe Street
PO Box 1961
Auckland 1140
14/10/2021Pending

Prescription
 

Composition

ComponentIngredientManufacturer
powder for injectionActive 
 Remdesivir 0.105 g (about 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 stepManufacturer
Finished Product TestingCharles 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 SpA
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 FormHikma 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 SpA
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
PackingHikma Farmaceutica (Portugal) Lda
Estrada do Rio da Mo no. 8, 8A & 8B
Fervenca
Terrugem - Sintra 2705-906
Portugal
 Patheon Italia SpA
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 PackagingAndersonBrecon 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 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 ReleaseGilead Sciences (NZ)
c/- Grant Thornton New Zealand Limited
L4, 152 Fanshawe Street
Auckland 1010

Packaging

PackageContentsShelf Life
Vial, glass, Type I clear, an elastomeric closure, and an aluminium overseal with a flip-off cap1 dose units36 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

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
14/10/2021New Higher-risk Medicine ApplicationAbridged new higher-risk medicine containing one or more new active substanceInformation requested 19/1/20223/12/2021 
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