Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
Zavesca 100 mg capsules.
| Pharmaceutical Form |
|---|
|
Capsule, hard. White capsules with “OGT 918” printed in black on the cap and “100” printed in black on the body. |
Each capsule contains 100 mg miglustat.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Miglustat |
Miglustat is an inhibitor of glucosylceramide synthase, the enzyme responsible for the first step in the synthesis of most glycolipids, and a pharmacokinetic enzyme stabiliser of cipaglucosidase alfa. Miglustat is indicated for the treatment of adult patients with mild to moderate type 1 Gaucher disease and for the treatment of progressive neurological manifestations in patients with Niemann-Pick type C disease. Also, miglustat must be used in combination with cipaglucosidase alfa for long-term enzyme replacement therapy in adults with late-onset Pompe disease (acid α-glucosidase [GAA] deficiency). |
| List of Excipients |
|---|
|
Capsule contents: Sodium starch glycollate Capsule shell: Gelatin Printing ink: Black iron oxide (E172) |
ACLAR/ALU blister strips supplied as a box of 4 blister strips, each blister strip containing 21 capsules providing a total of 84 capsules.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
EU/1/02/238/001
Date of first authorisation: 20 November 2002
Date of latest renewal: 08 December 2012
| Drug | Countries | |
|---|---|---|
| ZAVESCA | Austria, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Turkey, United Kingdom, United States |
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