Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Opella Healthcare UK Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Mizollen 10 mg modified-release tablets.
| Pharmaceutical Form |
|---|
|
Modified-release tablet. Oblong, white tablets with a scored line on one side and a mark “MZI 10” on the reverse side. |
Mizolastine 10mg per tablet.
Excipients with known effect:
Lactose monohydrate (125mg/tablet).
Hydrogenated castor oil (25mg/tablet).
Propylene glycol (0.45mg/tablet).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Mizolastine |
Mizolastine possesses antihistamine and antiallergic properties due to a specific and selective antagonism of peripheral histamine H1 receptors. |
| List of Excipients |
|---|
|
Core: Hydrogenated castor oil Film-coating: Hypromellose |
Aluminium/(oPA/Aluminium/PVC) blisters: Packs of 4, 7, 10, 15, 20, 30, 50 or 100 tablets.
Aluminium/PVC blisters: Packs of 4, 7, 10, 15, 20, 30, 50 or 100 tablets.
Polypropylene tablet container with polyethylene caps: Packs of 4, 7, 10, 15, 20, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.
Opella Healthcare UK Limited, trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
PL 53886/0046
Date of first authorisation: 7 March 2003
Date of latest renewal: 21 November 2005
| Drug | Countries | |
|---|---|---|
| MIZOLLEN | Germany, France, Israel, Netherlands, Tunisia, United Kingdom |
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