Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands
Vumerity 231 mg gastro-resistant hard capsules.
| Pharmaceutical Form |
|---|
|
Gastro-resistant hard capsule. White capsule, size 0 (approximately 18 mm in length), printed with ‘DRF 231 mg’ in black ink. |
Each gastro-resistant hard capsule contains 231 mg diroximel fumarate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Diroximel fumarate |
Diroximel fumarate is indicated for the treatment of relapsing forms of multiple sclerosis (MS). The mechanism by which diroximel fumarate exerts therapeutic effects in MS is not fully understood. Diroximel fumarate acts via the major active metabolite, monomethyl fumarate. Preclinical studies indicate that the pharmacodynamic responses of monomethyl fumarate appears to be mediated, at least in part, through activation of the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcriptional pathway. |
| List of Excipients |
|---|
|
Capsule contents: Methacrylic acid-ethyl acrylate copolymer (1: 1) type A Capsule shell: Hypromellose Capsule print (black ink): Shellac |
HDPE bottle with a polypropylene child-resistant closure and a silica gel desiccant.
Pack size:
Packs of 120 (1 bottle) or 360 (3 bottles) gastro-resistant hard capsules.
Not all pack sizes may be marketed.
Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands
EU/1/21/1585/001
EU/1/21/1585/002
| Drug | Countries | |
|---|---|---|
| VUMERITY | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Poland, Romania, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
