Revised: 31 May 2019
Medicines
Medsafe Product Detail | ![]() ![]() | |
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File ref: TT50-9422a |
Trade Name | Dose Form | Strength | Identifier |
Tecfidera | Modified release capsule | 240 mg | |
Sponsor | Application date | Registration situation | Classification |
Biogen NZ Biopharma Ltd P O Box 62-027 Mt Wellington Auckland 1641 | 1/11/2013 | Consent given Approval date: 24/7/2014 | Prescription |
Composition
Component | Ingredient | Manufacturer |
modified release capsule | Active | |
Dimethyl fumarate 240mg | Sigma-Aldrich Production GmbH Industriestrasse 25 Buchs CH-9470 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 step | Manufacturer |
Finished Product Testing | Corden Pharma Fribourg SA Route de Moncor 10 Villars-sur-Glane CH-1752 Switzerland |
FUJIFILM Diosynth Biotechnologies Denmark ApS Biotek 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 | |
Manufacture of Final Dose Form | Corden Pharma Fribourg SA Route de Moncor 10 Villars-sur-Glane CH-1752 Switzerland |
Janssen-Cilag SpA Via C. Janssen Borgo San Michele Latina 04100 Italy | |
Micronisation | Jetpharma SA via Sottobisio 42a Balerna CH-6828 Switzerland |
Packing | Enestia Belgium NV Klocknerstraat 1 Hamont-Achel 3930 Belgium |
Janssen-Cilag SpA Via C. Janssen Borgo San Michele Latina 04100 Italy | |
Secondary Packaging | FUJIFILM Diosynth Biotechnologies Denmark ApS Biotek Alle 1 Hillerod DK-3400 Denmark |
NZ Site of Product Release | Biogen NZ Biopharma Ltd 188 Quay Street Auckland 1010 |
Packaging
Package | Contents | Shelf Life |
Blister pack, PVC/PE/PVDC/Al, in a cardboard carton | 14 capsules | 48 months from date of manufacture stored at or below 30°C protect from light |
Blister pack, PVC/PE/PVDC/Al, in a cardboard carton | 56 capsules | 48 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 Date | Application Type | Change(s) | Status | Payment Date | Priority |
15/12/2022 | Changed Medicine Notification | Change in ownership | Granted 20/1/2023 | 20/12/2022 | |
1/11/2013 | New Higher-risk Medicine Application | Abridged new higher-risk medicine not containing a new active substance | Granted 24/7/2014 | 20/11/2013 |