OVA-MIT Tablet Ref.[28218] Active ingredients: Clomifene

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

Product name and form

Ova-mit 50 mg tablets.

Pharmaceutical Form

Tablet.

Light orange, round, flat scored tablets with Remedica’s logo on one side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains clomifene citrate 50 mg.

Excipient(s) with known effect:

This product contains 143.7 mg lactose and ponceau 4R, cochineal Red A aluminium lake E124.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Clomifene

Clomifene is a non-steroidal agent which stimulates ovulation in a high percentage of appropriately selected anovulatory women. The ovulatory response to clomifene therapy is mediated through increased output of pituitary gonadotrophins, which in turn stimulates the maturation and endocrine activity of the ovarian follicle.

List of Excipients

Povidone
Cellulose, microcrystalline
Lactose monohydrate
Maize starch
Starch, pregelatinised
Silica, colloidal anhydrous
Magnesium stearate
Talc
Quinoline yellow aluminium lake E104
Ponceau 4R, cochineal red A aluminium lake E124

Pack sizes and marketing

PVC/Aluminium blisters. Pack-size of 10 tablets.

PP containers with PE closure. Pack-sizes of 100 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

7874

Date of first authorization: 02 April 1981
Date of latest renewal: 05 June 2013

Drugs

Drug Countries
OVA-MIT Cyprus, Ecuador, Hong Kong, Singapore

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