<p>There are no adequate and well-controlled studies in pregnant or lactating women. To date, no other relevant epidemiological data are available. Data on a limited number of exposed pregnancies indicate no adverse effects of topical Ketoconazole on pregnancy or on the health of the foetus/newborn child. Animal studies have shown reproductive toxicity following oral administration of Ketoconazole. No effects on the breastfed newborn/infant are anticipated.</p>