MYCORIL Vaginal tablet Ref.[28282] Active ingredients: Clotrimazole

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Product name and form

Mycoril 100 mg vaginal tablets.

Mycoril 200 mg vaginal tablets.

Mycoril 500 mg vaginal tablets.

Pharmaceutical Form

Vaginal tablet.

Mycoril 100 mg vaginal tablets: White, bullet shaped tablets, embossed with Remedica’s logo on one side.

Mycoril 200 mg vaginal tablets: White, bullet shaped tablets, embossed with Remedica’s logo on one side and 200 on the other side.

Mycoril 500 mg vaginal tablets: White, bullet shaped tablets, embossed with Remedica’s logo on one side and 500 on the other side.

Qualitative and quantitative composition

Mycoril 100 mg vaginal tablets: Each vaginal tablet contains 100 mg clotrimazole.

Mycoril 200 mg vaginal tablets: Each vaginal tablet contains 200 mg clotrimazole.

Mycoril 500 mg vaginal tablets: Each vaginal tablet contains 500 mg clotrimazole.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Clotrimazole

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane. Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.

List of Excipients

Calcium lactate pentahydrate
Lactose monohydrate
Maize starch
Lactic acid
Hypromellose
Cellulose, microcrystalline
Crospovidone
Silica, colloidal anhydrous
Magnesium stearate

Pack sizes and marketing

Mycoril 100 mg vaginal tablets: Aluminium strips. The pack also contains an applicator. Pack-size of 6 vaginal tablets.

Mycoril 200 mg vaginal tablets: Aluminium strips. The pack also contains an applicator. Pack-size of 3 vaginal tablets.

Mycoril 500 mg vaginal tablets: Aluminium strips. The pack also contains an applicator. Pack-size of 1 vaginal tablet.

Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

Marketing authorization dates and numbers

Mycoril 100 mg vaginal tablets: 14906
Mycoril 200 mg vaginal tablets: 19874
Mycoril 500 mg vaginal tablets: 17952

Mycoril 100 mg vaginal tablets:

Date of first authorisation: 09 September 1994
Date of latest renewal: 01 September 2010

Mycoril 200 mg vaginal tablets:

Date of first authorisation: 13 December 2005
Date of latest renewal: 12 September 2011

Mycoril 500 mg vaginal tablets:

Date of first authorisation: 23 September 1998
Date of latest renewal: 21 July 2010

Drugs

Drug Countries
MYCORIL Cyprus, Hong Kong, Malta, Singapore

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