Medicine passport

Opfolda 65 mg harde capsules 65 mg

The same active substance, strength and form as listed by each country’s medicines regulator. For showing a pharmacist abroad.

Active substance
Miglustat
Strength
65 mg
Form
capsule, hard
ATC code
A16AX06
Registered in
Netherlands · Amicus Therapeutics Europe Limited
Prescription
Prescription only
RVG
EU/1/23/1737

Source: Geneesmiddeleninformatiebank · 2026-09-30

Not a prescription. Not a statement that these products are interchangeable. Products are matched on active substance, strength and kind of form only. Other ingredients, release, approved uses and the dose on the box can differ. A pharmacist or doctor decides whether one can replace another.

Listed in other countries

United States 1 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
Opfolda65 mg · CapsulePrescription onlyAMICUS THERAPEUTICS US, LLC71904-300

Source: NDC Directory (US Food and Drug Administration) · 2026-09-13 · Source: US Food and Drug Administration, NDC Directory.

Spain 1 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
OPFOLDA65 MG · cápsula duraPrescription onlyAmicus Therapeutics Europe Limited1231737001

Source: CIMA — Centro de Información online de Medicamentos (Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)) · 2026-09-30 · Fuente: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), CIMA.

France 1 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
OPFOLDA65 mg · gélulePrescription onlyAMICUS THERAPEUTICS EUROPE (IRLANDE)61479921

Source: Base de données publique des médicaments (ANSM / Ministère de la Santé) · 2026-09-30 · Source : Base de données publique des médicaments (ANSM / Ministère de la Santé), sous Licence Ouverte.

Canada 1 matching products

Name on the boxStrength and formPrescriptionHolderOfficial record
OPFOLDA65 mg · capsulePrescription onlyAmicus Therapeutics Canada Inc.02556812

Source: Drug Product Database (Health Canada) · 2026-09-30 · Contains information licensed under the Open Government Licence – Canada.

Same active substance, but no match for this strength and form

Countries covered: United States, Bulgaria, European Union, Spain, France, Netherlands, Canada, Switzerland. A country missing from the list may still sell this medicine: Mediclarum reads only these registers.

Register data as of 2026-09-30. Mediclarum stores nothing about you for this page. https://www.mediclarum.com/nl/en/medicines/opfolda-65-mg-harde-capsules-65-mg-capsule-hard