Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-10604 |
| Trade Name | Dose Form | Strength | Identifier |
| Rydapt | Soft gelatin capsule | 25 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Novartis New Zealand Ltd P O Box 99102 Newmarket Auckland 1149 | 6/3/2019 | Consent given Approval date: 24/10/2019 Notification date: 25/2/2021 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| soft gelatin capsule | Active | |
| Midostaurin 25mg | Novartis 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 step | Manufacturer |
| Finished Product Testing | Catalent Germany Eberbach GmbH Gammelsbacherstrasse 2 Eberbach Baden D-69412 GERMANY |
| Finished Product Testing - Microbiological | Labor LS SE & Co.KG Mangelsfeld 4, 5, 6 Bad Bocklet Grossenbrach 97708 GERMANY |
| Manufacture of Final Dose Form | Catalent Germany Eberbach GmbH Gammelsbacherstrasse 2 Eberbach Baden D-69412 GERMANY |
| Packing | Catalent 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 Release | Novartis New Zealand Ltd Private Office 3.15 12 Madden Street Wynyard Quarter Auckland 1010 |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, PA/Alu/PVC foil on Alu/HSL backing | 56 capsules | 36 months from date of manufacture stored at or below 30°C protect from moisture |
| Blister pack, PA/Alu/PVC foil on Alu/HSL backing | 112 capsules | 36 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 Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 2/4/2024 | Changed Medicine Notification | Active ingredient manufacture - G4; Finished product testing and/or primary packing site; Editorial updates to Module 3 documents | Awaiting payment | ||
| 6/3/2019 | New Higher-risk Medicine Application | Abridged new higher-risk medicine containing one or more new active substance | Granted 24/10/2019 | 12/4/2019 |
