Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
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File ref: TT50-9608 |
Trade Name | Dose Form | Strength | Identifier |
Sylvant | Powder for infusion concentrate | 100 mg | |
Sponsor | Application date | Registration situation | Classification |
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics P O Box 62027 Sylvia Park AUCKLAND 1644 | 8/8/2014 | Consent given Approval date: 2/7/2015 Notification date: 30/5/2016 | Prescription |
Composition
Component | Ingredient | Manufacturer |
powder for infusion concentrate | Active | |
Siltuximab 100mg | Janssen 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 step | Manufacturer |
Finished Product Testing | Cilag 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 Form | Cilag AG Hochstrasse 201 Schaffhausen CH-8200 SWITZERLAND |
Secondary Packaging | Cilag AG Hochstrasse 201 Schaffhausen CH-8200 SWITZERLAND |
DHL Supply Chain (Australia) Pty Limited 52 Huntingwood Drive Huntingwood NSW 2148 AUSTRALIA | |
NZ Site of Product Release | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 |
Packaging
Package | Contents | Shelf Life |
Vial, glass, Type 1 | 1 dose units | 36 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 Date | Application Type | Change(s) | Status | Payment Date | Priority |
24/11/2023 | Changed Medicine Notification | Data sheet - G2; Administrative fee (CMN) | Granted 18/12/2023 | 30/11/2023 | |
8/8/2014 | New Higher-risk Medicine Application | New higher-risk medicine containing one or more new active substances | Granted 2/7/2015 | 21/8/2014 | Y |