Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-10422 |
| Trade Name | Dose Form | Strength | Identifier |
| Mavenclad | Tablet | 10 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics P O Box 62027 Sylvia Park AUCKLAND 1644 | 17/5/2018 | Consent given Approval date: 1/8/2019 Notification date: 19/5/2020 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| tablet | Active | |
| Cladribine 10 mg | Cilag AG Hochstrasse 201 Schaffhausen CH-8200 Switzerland | |
| Excipient | ||
| Hydroxypropyl-beta-cyclodextrin | ||
| Magnesium stearate | ||
| Sorbitol | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | BSP Pharmaceuticals SpA Via Appia Km 65 651 (Loc Latina Scalo) Latina 04013 Italy |
| Eurofins Biolab Srl Via Bruno Buozzi, 2 Vimodrone Milan 20090 Italy | |
| NerPharMa SRL Viale Pasteur, 10 Nerviano (MI) 20014 Italy | |
| Manufacture of Final Dose Form | BSP Pharmaceuticals SpA Via Appia Km 65 651 (Loc Latina Scalo) Latina 04013 Italy |
| NerPharMa SRL Viale Pasteur, 10 Nerviano (MI) 20014 Italy | |
| Packing | NerPharMa SRL Viale Pasteur, 10 Nerviano (MI) 20014 Italy |
| R-Pharm Germany GmbH Heinrich -Mack-Str. 35 Illertissen 89257 Germany | |
| Secondary Packaging | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 |
| R-Pharm Germany GmbH Heinrich -Mack-Str. 35 Illertissen 89257 Germany | |
| 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 |
| Blister pack, Bottom foil PVC/Al/oPA, lidding foil BMM/Al/print primer, in child proof Al /carboard wallet | 1 tablets | 48 months from date of manufacture stored at or below 30°C protect from moisture |
| Blister pack, Bottom foil PVC/Al/oPA, lidding foil BMM/Al/print primer, in child proof Al /carboard wallet | 4 tablets | 48 months from date of manufacture stored at or below 30°C protect from moisture |
| Blister pack, Bottom foil PVC/Al/oPA, lidding foil BMM/Al/print primer, in child proof Al /carboard wallet | 5 tablets | 48 months from date of manufacture stored at or below 30°C protect from moisture |
| Blister pack, Bottom foil PVC/Al/oPA, lidding foil BMM/Al/print primer, in child proof Al /carboard wallet | 6 tablets | 48 months from date of manufacture stored at or below 30°C protect from moisture |
| Blister pack, Bottom foil PVC/Al/oPA, lidding foil BMM/Al/print primer, in child proof Al /carboard wallet | 7 tablets | 48 months from date of manufacture stored at or below 30°C protect from moisture |
| Blister pack, Bottom foil PVC/Al/oPA, lidding foil BMM/Al/print primer, in child proof Al /carboard wallet | 8 tablets | 48 months from date of manufacture stored at or below 30°C protect from moisture |
Indications
MAVENCLAD is indicated for the treatment of relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical relapses and to delay the progression of physical disability.
Following completion of the two treatment courses, no further cladribine treatment is required in years three and four. Re-initiation of therapy after year four has not been studied.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 13/4/2021 | Changed Medicine Notification | Active ingredient specifications/test methods - Grade 3; Shelf life/storage conditions - Grade 2 | Granted 8/6/2021 | 28/4/2021 | |
| 17/5/2018 | New Higher-risk Medicine Application | New higher-risk medicine that does not contain a new active substance | Granted 1/8/2019 | 6/7/2018 |
