PERIZAM Oral suspension Ref.[7160] Active ingredients: Clobazam

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK

Product name and form

Perizam 2mg/ml Oral Suspension.

Pharmaceutical Form

Oral Suspension.

An off-white suspension.

Qualitative and quantitative composition

Each ml of oral solution contains 2mg Clobazam.

Excipient(s) with known effect:

Sodium Methyl parahydroxybenzoate (E219) (1.32mg)
Sodium Propyl parahydroxybenzoate (E217) (0.33mg)
Liquid Maltitol (E965) (0.3g)
Propylene Glycol (E1520) (6.21mg)

For the full list of excipients, see section 6.1.

Active Ingredient Description
Clobazam

Clobazam is a 1,5-benzodiazepine and the pharmacodynamic activity is qualitatively similar to that of other compounds of the class of Muscle relaxant, Anxiolytic, Sedative, Hypnotic, Anticonvulsant, Amnesic.

List of Excipients

Aluminium magnesium silicate
Citric acid monohydrate (E330)
Disodium hydrogen phosphate dihydrate
Simethicone emulsion
Sucralose (E955)
Polysorbate 80 (E433)
Masking flavour (contains propylene glycol (E1520))
Raspberry flavour 545724E (contains propylene glycol (E1520))
Xanthan gum (E415)
Sodium methyl parahydroxybenzoate (E219) (Preservative)
Sodium propyl parahydroxybenzoate (E217) (Preservative)
Liquid maltitol (E965)
Purified water

Pack sizes and marketing

Bottle: Amber (Type III glass)

Closure: HDPE, EPE wadded, child resistant closure.

Pack size: 150ml

Syringe: Polypropylene body and HDPE plunger with a capacity of 5ml.

Bottle adaptor: Low Density Polyethylene. The bottle adaptor is not pre-fitted.

Marketing authorization holder

Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK

Marketing authorization dates and numbers

PL00427/0228

Date of last renewal: 26th of January 2020

Drugs

Drug Countries
PERIZAM United Kingdom

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