United States - English - NLM (National Library of Medicine)

physicians total care, inc. - pimecrolimus (unii: 7kyv510875) (pimecrolimus - unii:7kyv510875) - pimecrolimus 10 mg in 1 g - elidel ® (pimecrolimus) cream 1% is indicated as second-line  therapy  for the short-term and non-continuous chronic treatment of  mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. elidel cream is not indicated for use in children less than 2 years of age (see warnings, boxed warning, and precautions, pediatric use).  elidel ® (pimecrolimus) cream 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream.

United States - English - NLM (National Library of Medicine)

bausch health us, llc - pimecrolimus (unii: 7kyv510875) (pimecrolimus - unii:7kyv510875) - pimecrolimus 10 mg in 1 g - elidel cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. there are no adequate and well-controlled studies with elidel cream, 1% in pregnant women. therefore, elidel cream, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in dermal embryofetal developmental studies, no maternal or fetal toxicity was observed up to the highest practicable doses tested, 10 mg/kg/day (1% pimecrolimus cream) in rats (0.14x mrhd based on body surface area) and 10 mg/kg/day (1% pimecrolimus cream) in rabbits (0.65x mrhd based on auc comparisons). the 1% pimecrolimus cream was administered topically for 6 hours/day during the period of organogenesis in rats and rabbits (gestational days 6-21 in rats and gestational days 6-20 in rabbits). a second dermal embryofetal development study was conducted in rats using pimecrolimus cream applied dermally to pregnant rats (1 g cream/kg body weight of 0

Australia - English - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - pimecrolimus, quantity: 10 mg/g - cream - excipient ingredients: sodium hydroxide; citric acid; benzyl alcohol; sodium cetostearyl sulfate; mono- and di- glycerides; cetyl alcohol; stearyl alcohol; propylene glycol; oleyl alcohol; medium chain triglycerides; purified water - elidel 1% cream is indicated for patients 3 months of age and older with atopic dermatitis (eczema) for: short term treatment of signs and symptoms; intermittent long-term treatment of emerging and resolving lesions in atopic dermatitis where the use of a topical corticosteroid is not yet warranted, no longer needed, or is inadvisable (according to the usage restrictions in the respective topical corticosteroid product information).

Australia - English - Department of Health (Therapeutic Goods Administration)

meda pharmaceuticals pty ltd - pimecrolimus -

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - pimecrolimus 10 mg/g;   - topical cream - 1 % - active: pimecrolimus 10 mg/g   excipient: benzyl alcohol cetyl alcohol citric acid glyceryl monostearate medium-chain triglycerides oleyl alcohol propylene glycol purified water sodium cetostearyl sulfate sodium hydroxide stearyl alcohol - patients 3 months of age and older with atopic dermatitis (eczema) for the: · short-term treatment of signs and symptoms; and · intermittent long-term treatment of emerging and resolving lesions in atopic dermatitis where topical corticosteroids are ineffective, intolerable or inappropriate.

Malta - English - Medicines Authority

meda pharmaceuticals limited - pimecrolimus - cream - pimecrolimus 10 mg/g - other dermatological preparations

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

viatris uk healthcare ltd - pimecrolimus - cutaneous cream - 10mg/1gram

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

mawdsley-brooks & company ltd - pimecrolimus - cutaneous cream - 10mg/1gram

Malta - English - Medicines Authority

mylan ire healthcare limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - pimecrolimus - cream - pimecrolimus 10 mg/g - other dermatological preparations

Malta - English - Medicines Authority

viatris healthcare limited damastown industrial park, mulhuddart, dublin 15, dublin , ireland - cream - pimecrolimus 10 mg/g - other dermatological preparations