Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-8843 |
| Trade Name | Dose Form | Strength | Identifier |
| Prochymal | Solution for infusion | 100 million cells in 15mL | |
| Sponsor | Application date | Registration situation | Classification |
| CARSL Consulting P O Box 766 Hastings 4156 | 7/6/2011 | Approval lapsed Approval date: 14/6/2012 Notification date: 14/6/2016 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| solution for infusion | Active | |
| Remestemcel-L (100 million human mesenchymal stem cells in 15mL) | Lonza Walkersville Inc 8830 Biggs Ford Road Walkersville Maryland 21793-0127 United States of America | |
| Excipient | ||
| Albumin | ||
| Dimethyl sulfoxide | ||
| Plasma-Lyte A |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Lonza Walkersville Inc 8830 Biggs Ford Road Walkersville Maryland 21793-0127 United States of America |
| Osiris Therapeutics, Inc 7015 Albert Einstein Drive Columbia MD 21046 United States of America | |
| Manufacture of Final Dose Form | Lonza Walkersville Inc 8830 Biggs Ford Road Walkersville Maryland 21793-0127 United States of America |
| Packing | Lonza Walkersville Inc 8830 Biggs Ford Road Walkersville Maryland 21793-0127 United States of America |
| NZ Site of Product Release | CARSL Consulting 50B Puketapu Road Taradale Napier 4112 |
Packaging
| Package | Contents | Shelf Life |
| Bag, plastic, EVA cell storage bag | 15 mL | 36 months from date of manufacture stored below -135°C 5 hours reconstituted stored at or below 25°C |
Indications
Prochymal is indicated for the rescue of patients NLT 6 months to 17 years of age with acute graft versus host disease (aGvHD), refractory to treatment with systemic corticosteroid therapy or other immunosuppressive agents. Prochymal use under these conditions is limited to Grades B to D of the disease.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 14/4/2014 | Provisional Renewal | Renewal of provisional consent | Granted 5/6/2014 | 15/4/2014 | |
| 7/6/2011 | Provisional Consent (Section 23) | New higher-risk medicine containing one or more new active substances | Granted 14/6/2012 | 8/6/2011 | Y |
