Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-10422
Trade NameDose FormStrengthIdentifier
MavencladTablet10 mg
SponsorApplication dateRegistration situationClassification
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
P O Box 62027
Sylvia Park
AUCKLAND 1644
17/5/2018Consent given
Approval date: 1/8/2019
Notification date: 19/5/2020
Prescription
 

Composition

ComponentIngredientManufacturer
tabletActive 
 Cladribine 10 mgCilag AG
Hochstrasse 201
Schaffhausen CH-8200
Switzerland
 Excipient 
 Hydroxypropyl-beta-cyclodextrin
 Magnesium stearate
 Sorbitol
 Water for injection

Production

Manufacturing stepManufacturer
Finished Product TestingBSP 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 FormBSP Pharmaceuticals SpA
Via Appia Km 65 651
(Loc Latina Scalo)
Latina 04013
Italy
 NerPharMa SRL
Viale Pasteur, 10
Nerviano (MI) 20014
Italy
PackingNerPharMa SRL
Viale Pasteur, 10
Nerviano (MI) 20014
Italy
 R-Pharm Germany GmbH
Heinrich -Mack-Str. 35
Illertissen 89257
Germany
Secondary PackagingPharmacy 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 ReleasePharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022

Packaging

PackageContentsShelf Life
Blister pack, Bottom foil PVC/Al/oPA, lidding foil BMM/Al/print primer, in child proof Al /carboard wallet1 tablets48 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 wallet4 tablets48 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 wallet5 tablets48 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 wallet6 tablets48 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 wallet7 tablets48 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 wallet8 tablets48 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 DateApplication TypeChange(s)StatusPayment DatePriority
13/4/2021Changed Medicine NotificationActive ingredient specifications/test methods - Grade 3; Shelf life/storage conditions - Grade 2Granted 8/6/202128/4/2021 
17/5/2018New Higher-risk Medicine ApplicationNew higher-risk medicine that does not contain a new active substanceGranted 1/8/20196/7/2018 
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