European Union - English - EMA (European Medicines Agency)

virbac s.a. - leishmania infantum excreted secreted proteins - immunologicals - dogs - for the active immunisation of leishmania-negative dogs from six months of age to reduce the risk to develop an active infection and clinical disease after contact with leishmania infantum.the efficacy of the vaccine has been demonstrated in dogs submitted to multiple natural parasite exposure in zones with high infection pressure.onset of immunity: 4 weeks after the primary vaccination course.duration of immunity: 1 year after the last re-vaccination.

United Kingdom - English - VMD (Veterinary Medicines Directorate)

virbac - leishmania infantum excreted secreted proteins - lyophilisate for suspension for injection - inactivated parasitic vaccine - dogs

European Union - English - EMA (European Medicines Agency)

leti pharma, s.l.u. - recombinant protein q from leishmania infantum mon-1 - inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) - dogs - for active immunisation of dogs from 6 months of age to reduce the risk of developing a clinical case of leishmaniasis.

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

gilead sciences pty ltd - amphotericin b, quantity: 50 mg - injection, powder for - excipient ingredients: hydrogenated soy phosphatidylcholine; sucrose; dl-alpha-tocopherol; distearoylphosphatidylglycerol; sodium succinate; cholesterol - indications: ambisome is indicated for: prophylaxis in liver transplant patients at risk of systemic candida, aspergillus and cryptococcus infections, and for the treatment of systemic fungal infections caused by organisms susceptible to amphotericin b (see clinical trials). ambisome is indicated for the treatment of visceral leishmaniasis. clinical studies of efficacy in visceral leishmaniasis are limited to leishmania infantum. indicated as at 8 september 2003 :ambisome is indicated for: prophylaxis in liver transplant patients at risk of systemic candida, aspergillus and cryptococcus infections, and for the treatment of systemic fungal infections caused by organisms susceptible to amphotericin b (see clinical trials). ambisome is indicated for empirical treatment of presumed fungal infections in febrile neutropaenic patients whose fever has failed to respond to broad spectrum antibiotic treatment. ambisome is indicated for the treatment of visceral leishmaniasis. clinical studies of efficacy in visceral leishmaniasis are limited to leishmania infantum.

New Zealand - English - Medsafe (Medicines Safety Authority)

gilead sciences (nz) - amphotericin b 50mg - powder for injection - 50 mg - active: amphotericin b 50mg excipient: cholesterol hydrochloric acid alpha-tocopherol distearoylphosphatidylglycerol phosphatidylcholines, soya, hydrogenated phosphatidylglycerols as sodium salt sodium hydroxide sodium succinate sucrose - ambisome is indicated for: · prophylaxis in liver transplant patients at risk of systemic candida, aspergillus and cryptococcus infections, and for · the treatment of systemic fungal infections caused by organisms susceptible to amphotericin b. ambisome is indicated for empirical treatment of presumed fungal infections in febrile neutropaenic patients whose fever has failed to respond to broad spectrum antibiotic treatment. ambisome is indicated for the treatment of visceral leishmaniasis. clinical studies of efficacy in visceral leishmaniasis are limited to leishmania infantum.

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

sun pharmaceutical industries, inc. - amphotericin b (unii: 7xu7a7droe) (amphotericin b - unii:7xu7a7droe) - amphotericin b liposome for injection is indicated for the following: - empirical therapy for presumed fungal infection in febrile, neutropenic patients. - treatment of cryptococcal meningitis in hiv infected patients (see description of clinical studies) . - treatment of patients with aspergillus species, candida species and/or cryptococcus species infections (see above for the treatment of cryptococcal meningitis) refractory to amphotericin b deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin b deoxycholate. - treatment of visceral leishmaniasis. in immunocompromised patients with visceral leishmaniasis treated with amphotericin b liposome for injection, relapse rates were high following initial clearance of parasites (see description of clinical studies) . see dosage and administration for recommended doses by indication. amphotericin b liposome for injection is contraindicated in those patients who have demonstrated or have known hypersensiti

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

eugia us llc - amphotericin b (unii: 7xu7a7droe) (amphotericin b - unii:7xu7a7droe) - amphotericin b liposome for injection is indicated for the following: - empirical therapy for presumed fungal infection in febrile, neutropenic patients. - treatment of cryptococcal meningitis in hiv-infected patients (see description of clinical studies ). - treatment of patients with aspergillus species, candida species and/or cryptococcus species infections (see above for the treatment of cryptococcal meningitis) refractory to amphotericin b deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin b deoxycholate. - treatment of visceral leishmaniasis. in immunocompromised patients with visceral leishmaniasis treated with amphotericin b liposome for injection, relapse rates were high following initial clearance of parasites (see description of clinical studies ). see dosage and administration   for recommended doses by indication. eleven clinical studies supporting the efficacy and safety of amphotericin b were conducted. this clinical program include

Greece - English - HMA (Heads of Medicines Agencies)

laboratorios dr. esteve s.a. - domperidone 5 mg/ml - oral suspension - dogs - domperidone

Spain - English - HMA (Heads of Medicines Agencies)

laboratorios dr. esteve s.a. - domperidone 5 mg/ml - oral suspension - dogs - domperidone

Italy - English - HMA (Heads of Medicines Agencies)

laboratorios dr. esteve s.a. - domperidone 5 mg/ml - oral suspension - dogs - domperidone