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

kck pharmaceutical industries sdn. bhd. - prednisolone -

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: seeb pharma and medical supplies trading; distributor: seeb pharma and medical supplies trading - prednisolone - syrup - 3mg/5ml

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - clorexolone 10mg (and 25mg) - tablet - 10mg, 25mg - active: clorexolone 10mg (and 25mg)

Canada - English - Health Canada

novartis pharmaceuticals canada inc - potassium chloride - tablet (extended-release) - 600mg - potassium chloride 600mg - replacement preparations

Canada - English - Health Canada

biomed pharma - potassium chloride - tablet (extended-release) - 600mg - potassium chloride 600mg - replacement preparations

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

alcon laboratories, inc - rimexolone (unii: o7m2e4264d) (rimexolone - unii:o7m2e4264d) - rimexolone 10 mg in 1 ml - vexol® 1% (rimexolone ophthalmic suspension) is indicated for the treatment of postoperative inflammation following ocular surgery and in the treatment of anterior uveitis. vexol® 1% (rimexolone ophthalmic suspension) is contraindicated in epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and most other viral diseases of the cornea and conjunctiva; mycobacterial infection of the eye; fungal diseases of the eye; acute purulent untreated infections which, like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid; and in those persons with hypersensitivity to any component of the formulation.

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

marinus pharmaceuticals, inc. - ganaxolone (unii: 98wi44ohiq) (ganaxolone - unii:98wi44ohiq) - ztalmy is indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (cdkl5) deficiency disorder (cdd) in patients 2 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as ztalmy, during pregnancy. encourage women who are taking ztalmy during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no available data on ztalmy use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. in animal studies, adverse effects on development were observed in mice (fetal malformations) and rats (neurobehavioral and growth impairment) following exposure during organogenesis (mouse) or throughout gestation and lactation (rat) at maternal exposures lower than that in human adults at the

European Union - English - EMA (European Medicines Agency)

marinus pharmaceuticals emerald limited - ganaxolone - epileptic syndromes; spasms, infantile - other antiepileptics - ztalmy is indicated for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (cdkl5) deficiency disorder (cdd) in patients 2 to 17 years of age. ztalmy may be continued in patients 18 years of age and older.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmaco (nz) ltd - rimexolone 10 mg/ml - eye drops, suspension - 1 % - active: rimexolone 10 mg/ml excipient: benzalkonium chloride carbomer disodium edetate hydrochloric acid mannitol polysorbate 80 purified water sodium chloride sodium hydroxide

Ireland - English - HPRA (Health Products Regulatory Authority)

alcon laboratories (uk) ltd - rimexolone - eye drops suspension - 10 mg/ml - corticosteroids, plain