Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-9608
Trade NameDose FormStrengthIdentifier
SylvantPowder for infusion concentrate100 mg
SponsorApplication dateRegistration situationClassification
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
P O Box 62027
Sylvia Park
AUCKLAND 1644
8/8/2014Consent given
Approval date: 2/7/2015
Notification date: 30/5/2016
Prescription
 

Composition

ComponentIngredientManufacturer
powder for infusion concentrateActive 
 Siltuximab 100mgJanssen Sciences Ireland UC
Barnahely
Ringaskiddy
County Cork
IRELAND
  Janssen Biologics BV
Einsteinweg 101
Leiden 2333 CB
NETHERLANDS
  Janssen Biotech Inc
200 Great Valley Parkway
Malvern
Pennsylvania 19355
UNITED STATES OF AMERICA
 Excipient 
 Histidine
 Polysorbate 80
 Sucrose

Production

Manufacturing stepManufacturer
Finished Product TestingCilag AG
Hochstrasse 201
Schaffhausen CH-8200
SWITZERLAND
 Janssen Biologics BV
Einsteinweg 101
Leiden 2333 CB
NETHERLANDS
 Janssen Sciences Ireland UC
Barnahely
Ringaskiddy
County Cork
IRELAND
Manufacture of Final Dose FormCilag AG
Hochstrasse 201
Schaffhausen CH-8200
SWITZERLAND
Secondary PackagingCilag AG
Hochstrasse 201
Schaffhausen CH-8200
SWITZERLAND
 DHL Supply Chain (Australia) Pty Limited
52 Huntingwood Drive
Huntingwood
NSW 2148
AUSTRALIA
NZ Site of Product ReleasePharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022

Packaging

PackageContentsShelf Life
Vial, glass, Type 11 dose units36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
2 hours reconstituted stored at or below 25°C. prior to dilution
6 hours diluted stored at or below 25°C

Indications

SYLVANT is indicated for the treatment of adult patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
24/11/2023Changed Medicine NotificationData sheet - G2; Administrative fee (CMN)Granted 18/12/202330/11/2023 
8/8/2014New Higher-risk Medicine ApplicationNew higher-risk medicine containing one or more new active substancesGranted 2/7/201521/8/2014Y
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