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

viatris uk healthcare ltd - valganciclovir hydrochloride - oral tablet - 450mg

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

zentiva pharma uk ltd - valganciclovir hydrochloride - oral tablet - 450mg

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

accord-uk ltd - valganciclovir hydrochloride - oral tablet - 450mg

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

milpharm ltd - valganciclovir hydrochloride - oral tablet - 450mg

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - valganciclovir - film-coated tablet - 450 milligram(s) - nucleosides and nucleotides excl. reverse transcriptase inhibitors; valganciclovir

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - valganciclovir - film-coated tablet - 450 milligram(s) - nucleosides and nucleotides excl. reverse transcriptase inhibitors; valganciclovir

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - valganciclovir hydrochloride 496.3mg equivalent to valganciclovir 450 mg - film coated tablet - 450 mg - active: valganciclovir hydrochloride 496.3mg equivalent to valganciclovir 450 mg excipient: crospovidone microcrystalline cellulose opadry brown 15b565009 purified water stearic acid - for the treatment of cytomegalovirus (cmv) retinitis in acquired immunodeficiency syndrome (aids) patients. for the prevention of cmv disease in solid organ transplant patients at risk.

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

golden state medical supply inc. - valganciclovir hydrochloride (unii: 4p3t9qf9nz) (ganciclovir - unii:p9g3ckz4p5) - valganciclovir 450 mg

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

bausch & lomb incorporated - ganciclovir (unii: p9g3ckz4p5) (ganciclovir - unii:p9g3ckz4p5) - ganciclovir 1.5 mg in 1 g - zirgan ® (ganciclovir ophthalmic gel) 0.15% is indicated for the treatment of acute herpetic keratitis (dendritic ulcers). none. teratogenic effects ganciclovir has been shown to be embryotoxic in rabbits and mice following intravenous administration and teratogenic in rabbits. fetal resorptions were present in at least 85% of rabbits and mice administered 60 mg/kg/day and 108 mg/kg/day (approximately 10,000x and 17,000x the human ocular dose of 6.25 mcg/kg/day), respectively, assuming complete absorption. effects observed in rabbits included: fetal growth retardation, embryolethality, teratogenicity, and/or maternal toxicity. teratogenic changes included cleft palate, anophthalmia/microphthalmia, aplastic organs (kidney and pancreas), hydrocephaly, and brachygnathia. in mice, effects observed were maternal/fetal toxicity and embryolethality. daily intravenous doses of 90 mg/kg/day (14,000x the human ocular dose) administered to female mice prior to mating, during gestation, and during lactation caused hypoplasia of the testes and seminal vesicles in the month-old male offspring, as well as pathologic changes in the nonglandular region of the stomach [see carcinogenesis, mutagenesis, impairment of fertility (13.1)]. there are no adequate and well-controlled studies in pregnant women. zirgan should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. it is not known whether topical ophthalmic ganciclovir administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. caution should be exercised when zirgan is administered to nursing mothers. safety and efficacy in pediatric patients below the age of 2 years have not been established. no overall differences in safety or effectiveness have been observed between elderly and younger patients.

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

sandoz sa-nv - valganciclovir hydrochloride 496,3 mg - eq. valganciclovir 450 mg - film-coated tablet - 450 mg - valganciclovir hydrochloride 496.3 mg - valganciclovir