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

medimetriks pharmaceuticals, inc. - ozenoxacin (unii: v0lh498rfo) (ozenoxacin - unii:v0lh498rfo) - ozenoxacin 10 mg in 1 g

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

biofrontera inc. - ozenoxacin (unii: v0lh498rfo) (ozenoxacin - unii:v0lh498rfo) - xepi™ is indicated for the topical treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes in adult and pediatric patients 2 months of age and older [see clinical studies (14)] . none. risk summary there are no available data on the use of xepi in pregnant women to inform a drug associated risk. systemic absorption of xepi in humans is negligible following topical administration of xepi (up to twice the concentration of the marketed formulation) [see clinical pharmacology (12.3)] . due to the negligible systemic exposure, it is not expected that maternal use of xepi will result in fetal exposure to the drug. animal reproduction studies were not conducted with xepi. however, toxicity studies conducted in pregnant rats and rabbits administered the oral form of ozenoxacin showed no significant adverse developmental effects (at >10,000 times the maximum human plasma concentration seen with dermal application of ozenoxacin). the estimated background risk of major birth defects and miscarriag

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

cutanea life sciences, inc. - ozenoxacin (unii: v0lh498rfo) (ozenoxacin - unii:v0lh498rfo) - xepi™ is indicated for the topical treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes in adult and pediatric patients 2 months of age and older [see clinical studies (14)] . none. risk summary there are no available data on the use of xepi in pregnant women to inform a drug associated risk. systemic absorption of xepi in humans is negligible following topical administration of xepi (up to twice the concentration of the marketed formulation) [see clinical pharmacology (12.3)] . due to the negligible systemic exposure, it is not expected that maternal use of xepi will result in fetal exposure to the drug. animal reproduction studies were not conducted with xepi. however, toxicity studies conducted in pregnant rats and rabbits administered the oral form of ozenoxacin showed no significant adverse developmental effects (at >10,000 times the maximum human plasma concentration seen with dermal application of ozenoxacin). the estimated background risk of major birth defects and miscarriag

Canada - English - Health Canada

ferrer internacional, s.a. - ozenoxacin - cream - 1% - ozenoxacin 1% - antibiotics

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ferrer internacional s.a. - ozenoxacin 10 mg/g - cream - 10 mg/g - ozenoxacin 10 mg/g - ozenoxacin

Ireland - English - HPRA (Health Products Regulatory Authority)

ferrer internacional, s.a - ozenoxacin - cream - 10 milligram(s)/gram - other antibiotics for topical use

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - enoxacin 200mg (and 400mg) - tablet - 200 mg - active: enoxacin 200mg (and 400mg)

Bangladesh - English - DGDA (Directorate General of Drug Administration)

navana pharmaceuticals ltd. - ozenoxacin - cream - 10 mg/gm

Bangladesh - English - DGDA (Directorate General of Drug Administration)

incepta pharmaceuticals ltd. (dhamrai unit) - ozenoxacin - cream - 10 mg/gm

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

taisho pharmaceutical co., ltd. - garenoxacin mesilate hydrate - pale orange tablet (diameter: approx. 8.6 mm, thickness: approx. 4.7 mm)