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

bausch + lomb ireland - travoprost 0,04 mg/ml - eye drops, solution - 40 µg/ml - travoprost 40 µg/ml - travoprost

Canada - English - Health Canada

apotex inc - timolol (timolol maleate); travoprost - solution - 0.5%; 0.004% - timolol (timolol maleate) 0.5%; travoprost 0.004% - beta-adrenergic agents

Canada - English - Health Canada

novartis pharmaceuticals canada inc - travoprost - solution - 0.003% - travoprost 0.003% - prostaglandin analogs

Canada - English - Health Canada

alcon canada inc - travoprost - solution - 0.004% - travoprost 0.004% - prostaglandin analogs

Canada - English - Health Canada

novartis pharmaceuticals canada inc - travoprost - solution - 0.004% - travoprost 0.004% - prostaglandin analogs

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

glaukos corporation - travoprost (unii: wj68r08kx9) (travoprost - unii:wj68r08kx9) - idose® tr (travoprost intracameral implant) is indicated for the reduction of intraocular pressure (iop) in patients with open-angle glaucoma (oag) or ocular hypertension (oht). idose tr (travoprost intracameral implant) is contraindicated in patients with active or suspected ocular or periocular infections. idose tr is contraindicated in patients with corneal endothelial cell dystrophy (e.g., fuch’s dystrophy, corneal guttatae). idose tr is contraindicated in patients with prior corneal transplantation, or endothelial cell transplants (e.g., descemet’s stripping automated endothelial keratoplasty [dsaek]). idose tr is contraindicated in patients with hypersensitivity to travoprost or to any other components of the product. risk summary there are no adequate and well-controlled studies of idose tr (travoprost intracameral implant) administration in pregnant women to inform a drug-associated risk. subcutaneous administration of travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses. advise pregnant women of a potential risk to a fetus. idose tr should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. data animal data an embryo-fetal development study was conducted in pregnant rats administered travoprost once daily at doses up to 10 mcg/kg by subcutaneous injection from gestation day (gd) 6 to 17, to target the period of organogenesis. at 10 mcg/kg, 116 times the maximum human ocular dose (mhod) of 1 implant per eye, based on body surface area (bsa), assuming sustained travoprost release from the implant for 6 months or 0.0139 mcg/kg/day, travoprost was teratogenic in rats, evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, including fused sternebrae, domed head and hydrocephaly. travoprost caused post-implantation loss at 10 mcg/kg. the fetal no observed adverse effect level (noael) was 3 mcg/kg (34.5 times the maximum human ocular dose (mhod) of 1 implant per eye, based on bsa). an embryo-fetal development study was conducted in pregnant mice administered travoprost once daily by subcutaneous injection at doses up to 1 mcg/kg from gd 6 to 16, to target the period of organogenesis. travoprost induced an increase in post-implantation losses and a decrease in fetal viability in mice at subcutaneous doses > 0.3 mcg/kg. the fetal noael was 0.3 mcg/kg (1.7 times the mhod based on bsa). the maternal noael was 1 mcg/kg (5.8 times the mhod based on bsa). pre/postnatal development studies were conducted in rats administered travoprost once daily by subcutaneous injection from gd 7 (early embryonic period) to postnatal day 21 (end of lactation period). at doses of greater than or equal to 0.12 mcg/kg/day (1.4 times the mhod based on bsa), the incidence of post-natal mortality was increased, and neonatal body weight was decreased. neonatal development was also affected, evidenced by delayed eye opening, pinna detachment and preputial separation, and by decreased motor activity. risk summary there are no data on the effects of travoprost on the breastfed child or milk production. it is not known if travoprost is present in human milk following ophthalmic administration. the developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for idose tr and any potential adverse effects on the breast-fed child from idose tr. the safety and effectiveness of idose tr have not been established in pediatric patients. no overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novartis corporation (malaysia) sdn. bhd. - travoprost -

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

eg sa-nv - timolol maleate 6,83 mg/ml - eq. timolol 5 mg/ml; travoprost 0,04 mg/ml - eye drops, solution - timolol, combinations

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

novartis pharmaceuticals uk ltd - travoprost; timolol maleate - eye drops - 40microgram/1ml ; 5mg/1ml

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

accord-uk ltd - travoprost - eye drops - 40microgram/1ml