Medicines

 

Medsafe Product Detail

File ref: TT50-8843
Trade NameDose FormStrengthIdentifier
ProchymalSolution for infusion100 million cells in 15mL
SponsorApplication dateRegistration situationClassification
CARSL Consulting
P O Box 766
Hastings 4156
7/6/2011Approval lapsed
Approval date: 14/6/2012
Notification date: 14/6/2016
Prescription
 

Composition

ComponentIngredientManufacturer
solution for infusionActive 
 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 stepManufacturer
Finished Product TestingLonza 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 FormLonza Walkersville Inc
8830 Biggs Ford Road
Walkersville
Maryland 21793-0127
United States of America
PackingLonza Walkersville Inc
8830 Biggs Ford Road
Walkersville
Maryland 21793-0127
United States of America
NZ Site of Product ReleaseCARSL Consulting
50B Puketapu Road
Taradale
Napier 4112

Packaging

PackageContentsShelf Life
Bag, plastic, EVA cell storage bag15 mL36 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 DateApplication TypeChange(s)StatusPayment DatePriority
14/4/2014Provisional RenewalRenewal of provisional consentGranted 5/6/201415/4/2014 
7/6/2011Provisional Consent (Section 23)New higher-risk medicine containing one or more new active substancesGranted 14/6/20128/6/2011Y