Leaflet MIGLUSTAT ACCORD 100mg capsules

Product code:
W65802002
Quantity:
84
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 | 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 latest medicines list:
01-06-2026
Product code:
W65802002
Concentration:
100mg
Pharmaceutical form:
capsules
Quantity:
84
Product type:
Generic medicine
Price:
11810.89 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

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
11810.89 RON
Copayment
11810.89 RON
Patient
0.00 RON

G29 (C1) - Gaucher's disease

Price
11810.89 RON
Copayment
11810.89 RON
Patient
0.00 RON

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

Price
11810.89 RON
Copayment
11810.89 RON
Patient
0.00 RON