Ηνωμένο Βασίλειο - Αγγλικά - MHRA (Medicines & Healthcare Products Regulatory Agency)

almirall ltd - cream

Ιρλανδία - Αγγλικά - HPRA (Health Products Regulatory Authority)

almirall, s.a. - calcipotriol; betamethasone - cream - 50 micrograms/g + 0.5 milligram(s)/gram - calcipotriol, combinations

Κένυα - Αγγλικά - Pharmacy and Poisons Board

almirall s.a. ronda general mitre 151 08022 barcelona(spain) - ebastine - oral solution - 1 mg of ebastine 1 ml - other antihistamines for systemic use

Ηνωμένο Βασίλειο - Αγγλικά - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - eflornithine monohydrate chloride - cream - 115mg/1gram

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

almirall, llc - flurandrenolide (unii: 8eul29xuqt) (flurandrenolide - unii:8eul29xuqt) - for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, particularly dry, scaling localized lesions. topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations. use of cordran tape is not recommended for lesions exuding serum or in intertriginous areas.

Ηνωμένο Βασίλειο - Αγγλικά - MHRA (Medicines & Healthcare Products Regulatory Agency)

waymade healthcare plc - diclofenac sodium - cutaneous gel - 30mg/1gram

Ηνωμένο Βασίλειο - Αγγλικά - MHRA (Medicines & Healthcare Products Regulatory Agency)

dowelhurst ltd - diclofenac sodium - cutaneous gel - 30mg/1gram

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

almirall, llc - flurandrenolide (unii: 8eul29xuqt) (flurandrenolide - unii:8eul29xuqt) - flurandrenolide 0.5 mg in 1 g - cordran® (flurandrenolide, usp) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

almirall, llc - tirbanibulin (unii: 4v9848rs5g) (tirbanibulin - unii:4v9848rs5g) - klisyri is indicated for the topical treatment of actinic keratosis on the face or scalp. none. risk summary there are no available data with klisyri use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of tirbanibulin to pregnant rats during the period of organogenesis resulted in an increased incidence of fetal deaths and malformations at a systemic exposure that was at least 74 times the exposure associated with the maximum recommended human dose (mrhd). oral administration of tirbanibulin to pregnant rabbits during the period of organogenesis resulted in reduced mean fetal weight and size at a systemic exposure that was 159 times the exposure associated with the mrhd (see data ). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data tirbanibulin induced fetal deaths and external, visceral, and skeletal malformations when administered orally to pregnant rats during the period of organogenesis at doses greater than or equal to 1.25 mg/kg/day, which resulted in systemic exposures at least 74 times the exposure associated with the mrhd on an area under the curve (auc) comparison basis. tirbanibulin had no apparent effects on fetal development in rats at a dose of 0.5 mg/kg/day, which resulted in systemic exposures 18 times the exposure associated with the mrhd. tirbanibulin reduced mean fetal weight and size (crown-rump length) when administered orally to pregnant rabbits during the period of organogenesis at a dose of 3 mg/kg/day, which resulted in a systemic exposure 159 times the exposure associated with the mrhd on an auc comparison basis. tirbanibulin had no apparent effects on fetal development in rabbits at a dose of 1 mg/kg/day, which resulted in systemic exposures 53 times the exposure associated with the mrhd. tirbanibulin was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation at dosages up to 1.25 mg/kg/day. these dosages resulted in systemic exposures up to 74 times the exposure associated with the mrhd on an auc comparison basis. no adverse effects on maternal function or developmental, neurobehavioral, or reproductive performance of offspring were observed. risk summary there are no data on lactational transfer of klisyri to human or animal milk. the effects of klisyri on the breastfed infant, or its effects on milk production, are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for klisyri and any potential adverse effects on the breastfed child from tirbanibulin or from the underlying maternal condition. the safety and effectiveness of klisyri for actinic keratosis in subjects less than 18 years of age have not been established. actinic keratosis is not a condition generally seen within the pediatric population. of the 353 subjects with ak treated with klisyri in the 2 controlled phase 3 trials, 246 (70%) were 65 years of age or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Ιρλανδία - Αγγλικά - HPRA (Health Products Regulatory Authority)

almirall, s.a. - aceclofenac - tablets - 100 milligram