KETOCONAZOLE HRA Tablet Ref.[8866] Active ingredients: Ketoconazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Laboratoire HRA Pharma, 15 rue Béranger, 75003 Paris, France

Product name and form

Ketoconazole HRA 200 mg tablets.

Pharmaceutical Form

Tablet.

Off-white to light cream, round, 10 mm diameter, biconvex.

Qualitative and quantitative composition

Each tablet contains 200 mg ketoconazole.

Excipient with known effect: each tablet contains 19 mg of lactose (as lactose monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ketoconazole

Ketoconazole is an imidazole-dioxolane antimycotic, active against yeasts, including Malassezia and dermatophytes.
List of Excipients

Maize starch
Lactose monohydrate
Povidone
Microcrystalline cellulose
Silica colloidal
Magnesium stearate

Pack sizes and marketing

PVC/Alu blister of 10 tablets.

Pack sizes containing 6 blisters of 10 tablets.

Marketing authorization holder

Laboratoire HRA Pharma, 15 rue Béranger, 75003 Paris, France

Marketing authorization dates and numbers

EU/1/14/965/001

Date of first authorisation: 19 November 2014

 
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