Dimethyl fumarate Polpharma
·
- Prescription status not stated
- Cancer treatments and immune-system medicines
- Active substance
- Dimethyl fumarate
- Made by
- Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Dimethyl fumarate Polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.
From the official label · 2026-09-30 · European Medicines Agency
How it works
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (dimethyl fumarate). It describes the substance, not this Bulgarian product — its uses and doses can differ.
The mechanism by which dimethyl fumarate (DMF) exerts its therapeutic effect in multiple sclerosis is unknown.
DMF and the metabolite, monomethyl fumarate (MMF), have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans.
In humans, dimethyl fumarate is extensively metabolized by esterases, which are ubiquitous in the gastrointestinal tract, blood, and tissues, before it reaches the systemic circulation.
Following administration of dimethyl fumarate delayed-release capsules 240 mg twice a day with food, the mean C max of MMF was 1.87 mg/L and AUC was 8.21 mg.hr/L in MS patients.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-10-30
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
BulgariaNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A. |
|---|---|
| Active substance | Dimethyl fumarate |
| Used in | Cancer treatments and immune-system medicines |
| Classification | L04AX07 · Cancer treatments and immune-system medicines |
| Generic | Yes — a generic medicine, according to the register |
| Authorised on | 2022-05-13 |
| Last updated by the regulator | 2023-12-22 |
| EMA product number | EMEA/H/C/005955 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.