Marekani - Kiingereza - NLM (National Library of Medicine)

a-s medication solutions - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - finacea® (azelaic acid) gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. none. there are no adequate and well-controlled studies in pregnant women. therefore, finacea gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% gel. oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. azelaic acid was administered during the period of organogenesis in all three animal species. embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. e

Marekani - Kiingereza - NLM (National Library of Medicine)

a-s medication solutions - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - finacea gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. limitations of use although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. none. risk summary azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology (12.3)]. in animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during the period of organogenesis at doses 162, 19, and 65 times the maximum recommended human dose (mrhd) in rats, rabbits, and monkeys, respectively. maternal toxicity was noted at these doses but no malformations were observed in these embryofetal developmental studies (see data). the background risk of major b

Australia - Kiingereza - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ceva animal health pty ltd - azelaic acid - unknown - azelaic acid acid active 0.0 - active constituent

Malta - Kiingereza - Medicines Authority

leo pharma a/s industriparken 55, 2750-dk ballerup, denmark - azelaic acid - cream - azelaic acid 20 % (w/w) - anti-acne preparations

Malta - Kiingereza - Medicines Authority

jenapharm gmbh & co. kg - azelaic acid - cream - azelaic acid 20 percent weight/weight - anti-acne preparations

Marekani - Kiingereza - NLM (National Library of Medicine)

psodex usa inc - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1), azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - condition worsens or does not improve after regular use of this product as directed. treats and controls symptoms of rosacea reduces redness and inflammation associated with rosacea promotes even skin tone minimizes the appearance of blood vessels

Ayalandi - Kiingereza - HPRA (Health Products Regulatory Authority)

bayer limited - azelaic acid - gel - 15 percent - other anti-acne preparations for topical use; azelaic acid

Ayalandi - Kiingereza - HPRA (Health Products Regulatory Authority)

leo pharma a/s - azelaic acid - gel - 15 percent - other anti-acne preparations for topical use; azelaic acid

Nyuzilandi - Kiingereza - Medsafe (Medicines Safety Authority)

leo pharma limited - azelaic acid 20% - topical cream - 20 % - active: azelaic acid 20% excipient: benzoic acid cetearyl octanoate glycerol cutina cbs polyethylene glycol 200 monostearate propylene glycol purified water - topical treatment of acne vulgaris.

Marekani - Kiingereza - NLM (National Library of Medicine)

almirall, llc - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelex ® cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris. azelex ® cream is contraindicated in individuals who have shown hypersensitivity to any of its components.