Kanada - angielski - Health Canada

janssen inc - itraconazole - capsule - 100mg - itraconazole 100mg - azoles

Kanada - angielski - Health Canada

janssen inc - itraconazole - solution - 10mg - itraconazole 10mg - azoles

Wielka Brytania - angielski - MHRA (Medicines & Healthcare Products Regulatory Agency)

serb - primidone - oral tablet - 250mg

Kanada - angielski - Health Canada

jamp pharma corporation - itraconazole - solution - 10mg - itraconazole 10mg - azoles

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - asciminib hydrochloride (unii: c5u34s9xfv) (asciminib - unii:l1f3r18w77) - scemblix is indicated for the treatment of adult patients with: - philadelphia chromosome-positive chronic myeloid leukemia (ph+ cml) in chronic phase (cp), previously treated with two or more tyrosine kinase inhibitors (tkis). - ph+ cml in cp with the t315i mutation. none. risk summary based on findings from animal studies and the mechanism of action, scemblix can cause embryo-fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on scemblix use in pregnant women to evaluate a drug-associated risk. animal reproduction studies in pregnant rats and rabbits demonstrated that oral administration of asciminib during organogenesis induced structural abnormalities, embryo-fetal mortality, and alterations to growth (see data ). advise pregnant women and females of reproductive potential of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies i

Unia Europejska - angielski - EMA (European Medicines Agency)

novartis europharm limited - asciminib hydrochloride - leukemia, myelogenous, chronic, bcr-abl positive - antineoplastic agents - scemblix is indicated for the treatment of adult patients with philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (ph+ cml cp) previously treated with two or more tyrosine kinase inhibitors (see section 5.1).

Australia - angielski - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - itraconazole, quantity: 100 mg - capsule - excipient ingredients: hypromellose; macrogol 20000; sucrose; hydrolysed maize starch; titanium dioxide; purified water; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - itracap is indicated for use in adults for the treatment of: ? superficial dermatomycoses not responding to topical treatment. ? fungal keratitis which has failed to respond to topical treatment or where the disease is either progressing rapidly or is immediately sight threatening. ? pityriasis versicolor not responding to any other treatment. ? vulvovaginal candidiasis not responding to topical treatment. ? oral candidiasis in immunocompromised patients. ? onychomycosis caused by dermatophytes. ? systemic mycoses: - systemic aspergillosis, histoplasmosis, sporotrichosis. - treatment and maintenance therapy in aids patients with disseminated or chronic pulmonary histoplasmosis infection. - treatment of oropharyngeal and/or oesophageal candidiasis when first line systemic antifungal therapy is inappropriate or has proven ineffective. - treatment of non-invasive candidiasis in non-neutropenic patients when first-line systemic antifungal therapy is inappropriate or has proven ineffective. this may be due to underlying pathology, insensitivity of the pathogen or drug toxicity.

Kanada - angielski - Health Canada

pfizer canada ulc - voriconazole - tablet - 50mg - voriconazole 50mg - azoles

Kanada - angielski - Health Canada

pfizer canada ulc - voriconazole - tablet - 200mg - voriconazole 200mg - azoles

Kanada - angielski - Health Canada

pfizer canada ulc - voriconazole - powder for solution - 200mg - voriconazole 200mg - azoles