OPFOLDA
As listed in the register: OPFOLDA
65 mg · capsule
- Prescription only
- Digestion, stomach, diabetes and nutrition
- Active substance
- Miglustat
- Made by
- Amicus Therapeutics Canada Inc.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (Miglustat). It describes the substance, not this exact product.
Type 1 Gaucher disease is caused by a functional deficiency of glucocerebrosidase, the enzyme that mediates the degradation of the glycosphingolipid glucosylceramide.
Miglustat functions as a competitive and reversible inhibitor of the enzyme glucosylceramide synthase, the initial enzyme in a series of reactions which results in the synthesis of most glycosphingolipids.
In healthy subjects, 67% of the administered dose was excreted unchanged in urine over 72 hours.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-12-31
Safety of the active substance
From the US prescribing label for the same active substance (Miglustat). It describes the substance, not this exact product.
The most common serious adverse reaction reported with miglustat capsule treatment in clinical trials was peripheral neuropathy [see Warnings and Precautions ( 5.1 )].
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
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
European UnionNo exact match for this strength and form
Netherlands1 matching products
SwitzerlandNo exact match for this strength and form
Details
| Made by | Amicus Therapeutics Canada Inc. |
|---|---|
| Active substance | Miglustat |
| Used in | Digestion, stomach, diabetes and nutrition |
| Strength | 65 mg |
| Form | capsule |
| Classification | A16AX06 · Digestion, stomach, diabetes and nutrition |
| Route | oral |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Marketed |
| Marketed | Yes, according to the register |
| DIN | 02556812 |
| DPD drug code | 106020 |
Source: Drug Product Database · 2026-09-30 · not reviewed by a clinician
Contains information licensed under the Open Government Licence – Canada. Reuse terms: Open Government Licence – Canada.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.