Medicine guide

Opfolda

·

  • Prescription status not stated
  • Digestion, stomach, diabetes and nutrition
Active substance
Miglustat
Made by
Amicus Therapeutics Europe Limited

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

What it is for

  • Opfolda (miglustat) is an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in adults with late-onset Pompe disease (acid ?- glucosidase [GAA] deficiency).

From the official label · 2026-09-30 · European Medicines Agency

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

FranceNo 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 byAmicus Therapeutics Europe Limited
Active substanceMiglustat
Used inDigestion, stomach, diabetes and nutrition
ClassificationA16AX06 · Digestion, stomach, diabetes and nutrition
Authorised on2023-06-26
Last updated by the regulator2025-02-14
EMA product numberEMEA/H/C/005695

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.