Ιρλανδία - Αγγλικά - HPRA (Health Products Regulatory Authority)

almirall, s.a. - ebastine - oral lyophilisate - 10 milligram

Ιρλανδία - Αγγλικά - HPRA (Health Products Regulatory Authority)

almirall, s.a. - ebastine - oral lyophilisate - 20 milligram

Ιρλανδία - Αγγλικά - HPRA (Health Products Regulatory Authority)

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

Ιρλανδία - Αγγλικά - HPRA (Health Products Regulatory Authority)

almirall, s.a. - ebastine - oral lyophilisate - 20 milligram

Ιρλανδία - Αγγλικά - HPRA (Health Products Regulatory Authority)

almirall, s.a. - ebastine - oral lyophilisate - 10 milligram

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

almirall, llc - retapamulin (unii: 4mg6o8991r) (retapamulin - unii:4mg6o8991r) - retapamulin 10 mg - altabax® is indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) due to staphylococcus aureus (methicillin-susceptible isolates only) or streptococcus pyogenes [see clinical studies (14)] . safety in patients younger than 9 months has not been established. to reduce the development of drug-resistant bacteria and maintain the effectiveness of altabax and other antibacterial drugs, altabax should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. none. risk summary there are no available data on altabax use in pregnant women to inform any drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. retapamulin is negligibly absorbed systemically following topical administration and maternal use is not expected to result in fetal exp

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

almirall, llc - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 75 mg - acticlate® and acticlate® cap are indicated for treatment of rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsial pox, and tick fevers caused by rickettsiae . acticlate and acticlate cap are indicated for treatment of the following sexually transmitted infections: - uncomplicated urethral, endocervical or rectal infections caused by chlamydia trachomatis . - nongonococcal urethritis caused by ureaplasma urealyticum . - lymphogranuloma venereum caused by chlamydia trachomatis . - granuloma inguinale caused by klebsiella granulomatis . - uncomplicated gonorrhea caused by neisseria gonorrhoeae . - chancroid caused by haemophilus ducreyi . acticlate and acticlate cap are indicated for treatment of the following respiratory tract infections: - respiratory tract infections caused by mycoplasma pneumoniae . - psittacosis (ornithosis) caused by chlamydophila psittaci . - because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, c

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

almirall, llc - desonide (unii: j280872d1o) (desonide - unii:j280872d1o) - desonide 0.5 mg in 1 g - verdeso® (desonide) foam, 0.05% is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. patients should be instructed to use verdeso foam for the minimum amount of time necessary to achieve the desired results because of the potential for verdeso foam to suppress the hypothalamic-pituitary-adrenal (hpa) axis. treatment should not exceed 4 consecutive weeks. none. risk summary there are no available data on verdeso foam 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, topical administration of a desonide cream, 0.05% formulation during organogenesis caused malformations characteristic of corticosteroids in rats and in rabbits (see data) . the available data do not allow the calculation of relevant comparisons between the systemic exposure of desonide observed in animal studies to the systemic exposure that would be expected in humans aft

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

almirall, llc - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - clindamycin 10 mg in 1 g - veltin™ (clindamycin phosphate and tretinoin) gel, 1.2%/0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years and older. veltin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. pregnancy category c. there are no well-controlled studies in pregnant women treated with veltin gel. veltin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. a limit teratology study performed in sprague dawley rats treated topically with veltin gel or 0.025% tretinoin gel at a dose of 2 ml/kg during gestation days 6 to 15 did not result in teratogenic effects. although no systemic levels of tretinoin were detected, craniofacial and heart abnormalities were described in drug-treated groups. these abnormalities are consistent with retinoid effects and occurred at 16 times the recommended clinical dose assuming 100% absorption and based on body surface area comparison. for p

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

almirall ltd - aceclofenac - oral tablet - 100mg