Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| 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 155 Fanshawe Street Auckland Central, 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 |
| 16/10/2023 | Self-Assessable Change Notification | Data sheet - G1 (Self assessable) | Notified | 30/10/2023 | |
| 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 |
