Leaflet MIGLUSTAT ACCORD 100mg capsules


Indicated for: Gaucher disease; Niemann-Pick type C disease

Route of administration: oral

Substance: miglustat (enzyme inhibitor)

ATC: A16AX06 (Alimentary tract and metabolism | Other alimentary tract and metabolism products | Various alimentary tract and metabolism products)

Miglustat is a glucosylceramide synthase inhibitor used for the treatment of type 1 Gaucher disease and Niemann-Pick type C disease. It works by reducing the production of glycosphingolipids, which accumulate in cells due to these conditions.

The medication is taken orally, usually three times daily, with the dose adjusted based on the patient's weight and response to treatment. Common side effects include diarrhea, flatulence, abdominal pain, and weight loss.

Miglustat is contraindicated in patients with severe renal impairment or hypersensitivity to the active substance. Its use also requires careful monitoring of gastrointestinal function and body weight.

This medication is an important option for managing lysosomal storage disorders, helping to alleviate symptoms and slow disease progression.

General data about MIGLUSTAT ACCORD 100mg

  • Substance: miglustat
  • Date of last drug list: 01-05-2026
  • Commercial code: W65802002
  • Concentration: 100mg
  • Pharmaceutical form: capsules
  • Quantity: 84
  • Product type: generic
  • Price: 11810.89 RON
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: G.L. PHARMA GMBH - AUSTRIA
  • Holder: ACCORD HEALTHCARE POLSKA SP. Z O.O. - POLONIA
  • Number: 10678/2018/02
  • Shelf life: 4 years

Compensation lists for MIGLUSTAT ACCORD 100mg Accord

G12 (C1) - Parkinson's disease

Price

Copayment

Patient

11810.89 RON

11810.89 RON

0.00 RON

G29 (C1) - Gaucher's disease

Price

Copayment

Patient

11810.89 RON

11810.89 RON

0.00 RON

GX (C1) - GENERIC (used in compensation list, C1, for another diagnosis)

Price

Copayment

Patient

11810.89 RON

11810.89 RON

0.00 RON