Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-9422a
Trade NameDose FormStrengthIdentifier
TecfideraModified release capsule240 mg
SponsorApplication dateRegistration situationClassification
Biogen NZ Biopharma Ltd
P O Box 62-027
Mt Wellington
Auckland 1641
1/11/2013Consent given
Approval date: 24/7/2014
Prescription
 

Composition

ComponentIngredientManufacturer
modified release capsuleActive 
 Dimethyl fumarate 240 mgSigma-Aldrich Chemie GmbH
Industriestrasse 25
Buchs CH-9471
Switzerland
  Cilag AG
Hochstrasse 201
Schaffhausen CH-8200
Switzerland
 Excipient 
 Brilliant blue FCF
  
 Colloidal silicon dioxide
 Croscarmellose sodium
 Gelatin
  
 Iron oxide yellow
  
 Magnesium stearate
 Methacrylic acid copolymer
  
 Microcrystalline cellulose
 Polysorbate 80
 Purified talc
 Simeticone
 Sodium laurilsulfate
  
 TekPrint black SW-9008
 Titanium dioxide
  
 Triethyl citrate
  

Production

Manufacturing stepManufacturer
Finished Product TestingBiogen Idec Denmark Manufacturing ApS
Biogen Idec Alle 1
Hillerod DK-3400
Denmark
 Janssen-Cilag SpA
Via C. Janssen
Borgo San Michele
Latina 04100
Italy
 PPD Development Ireland Ltd
Building C, Garrycastle Business & Technology Park
Athlone
Co. Westmeath
Ireland
 Vifor Pharma
Route de Moncor 10
Villars-sur-Glane CH-1752
Switzerland
Manufacture of Final Dose FormJanssen-Cilag SpA
Via C. Janssen
Borgo San Michele
Latina 04100
Italy
 Vifor Pharma
Route de Moncor 10
Villars-sur-Glane CH-1752
Switzerland
MicronisationJetpharma SA
via Sottobisio 42a
Balerna CH-6828
Switzerland
PackingEnestia Belgium NV
Klocknerstraat 1
Hamont-Achel 3930
Belgium
 Janssen-Cilag SpA
Via C. Janssen
Borgo San Michele
Latina 04100
Italy
Secondary PackagingBiogen Idec Denmark Manufacturing ApS
Biogen Idec Alle 1
Hillerod DK-3400
Denmark
NZ Site of Product ReleaseBiogen NZ Biopharma Ltd
188 Quay Street
Auckland 1010

Packaging

PackageContentsShelf Life
Blister pack, PVC/PE/PVDC/Al, in a cardboard carton14 capsules48 months from date of manufacture stored at or below 30°C protect from light
Blister pack, PVC/PE/PVDC/Al, in a cardboard carton56 capsules48 months from date of manufacture stored at or below 30°C protect from light

Indications

Tecfidera is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
17/3/2020Self-Assessable Change NotificationData sheet - miscellaneous changes (Self assessable)Notified20/3/2020 
1/11/2013New Higher-risk Medicine ApplicationAbridged new higher-risk medicine not containing a new active substanceGranted 24/7/201420/11/2013 
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