Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-10604
Trade NameDose FormStrengthIdentifier
RydaptSoft gelatin capsule25 mg
SponsorApplication dateRegistration situationClassification
Novartis New Zealand Ltd
P O Box 99102
Newmarket
Auckland 1149
6/3/2019Not available
Approval date: 24/10/2019
Notification date: 25/10/2019
Prescription
 

Composition

ComponentIngredientManufacturer
soft gelatin capsuleActive 
 Midostaurin 25 mgNovartis Pharma Schweizerhalle AG
Rothausstrasse
Pratteln 4133
Switzerland
 Excipient 
 Corn oil, ethoxylated
 dl-Alpha tocopherol
 Ethanol
 Gelatin
 Glycerol
 Iron oxide red
 Iron oxide yellow
 Macrogol 400
 PEG-40 castor oil
 Purified water
 Red printing ink (catalent)
 Titanium dioxide

Production

Manufacturing stepManufacturer
Finished Product TestingCatalent Germany Eberbach GmbH
Gammelsbacherstrasse 2
Eberbach
Baden D-69412
Germany
Finished Product Testing - MicrobiologicalLabor LS SE & Co.KG
Mangelsfeld 4, 5 & 6
Bad Bocklet
Grossenbrach 97708
Germany
Manufacture of Final Dose FormCatalent Germany Eberbach GmbH
Gammelsbacherstrasse 2
Eberbach
Baden D-69412
Germany
PackingCatalent Germany Eberbach GmbH
Gammelsbacherstrasse 2
Eberbach
Baden D-69412
Germany
 Catalent Germany Schorndorf GmbH
Steinbeisstrasse 1 and 2
Schorndorf D-73614
Germany
 DHL Supply Chain (New Zealand) Ltd
6 Manu Tapu Drive
Mangere
Auckland 2022
NZ Site of Product ReleaseNovartis New Zealand Ltd
109 Carlton Gore Road
Newmarket
Auckland 1023

Packaging

PackageContentsShelf Life
Blister pack, PA/Alu/PVC foil on Alu/HSL backing56 capsules36 months from date of manufacture stored at or below 30°C protect from moisture
Blister pack, PA/Alu/PVC foil on Alu/HSL backing112 capsules36 months from date of manufacture stored at or below 30°C protect from moisture

Indications

Rydapt® is indicated:
· In combination with standard anthracycline and cytarabine induction and cytarabine consolidation chemotherapy, followed in patients in complete response by single agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive
· For the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasms (SM-AHN), or mast cell leukaemia (MCL).

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
28/4/2020Self-Assessable Change NotificationLabelling - Grade 1 (Self assessable); Data sheet - miscellaneous changes (Self assessable)Notified4/5/2020 
6/3/2019New Higher-risk Medicine ApplicationAbridged new higher-risk medicine containing one or more new active substanceGranted 24/10/201912/4/2019 
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