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

accord healthcare pty ltd - irinotecan hydrochloride trihydrate, quantity: 300 mg - injection, concentrated - excipient ingredients: sodium hydroxide; lactic acid; hydrochloric acid; sorbitol; water for injections - irinotecan hydrochloride is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. irinotecan hydrochloride is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

accord healthcare pty ltd - irinotecan hydrochloride trihydrate, quantity: 500 mg - injection, concentrated - excipient ingredients: hydrochloric acid; water for injections; lactic acid; sodium hydroxide; sorbitol - irinotecan hydrochloride is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. irinotecan hydrochloride is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

accord healthcare pty ltd - aciclovir, quantity: 25 mg/ml - injection, solution - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid - aciclovir intravenous infusion is indicated for the purpose of:,1. promoting resolution of acute clinical manifestations of mucocutaneous herpes simplex virus infections in immunocompromised patients.,2. treatment of severe first episode primary or non-primary genital herpes in immune competent patients.,3. treatment of acute manifestations of varicella zoster virus infection in immunocompromised patients.,4. treatment of shingles (varicella zoster virus infection) in immune competent patients who show very severe acute local or systemic manifestations of the disease. benefits can be expected in patients with rash duration shorter than 72 hours. the use of the intravenous infusion may be warranted in only a small subgroup of immune competent patients with shingles.,5. treatment of herpes simplex encephalitis.

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

accord healthcare pty ltd - aciclovir, quantity: 25 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; water for injections; sodium hydroxide - aciclovir intravenous infusion is indicated for the purpose of:,1. promoting resolution of acute clinical manifestations of mucocutaneous herpes simplex virus infections in immunocompromised patients.,2. treatment of severe first episode primary or non-primary genital herpes in immune competent patients.,3. treatment of acute manifestations of varicella zoster virus infection in immunocompromised patients.,4. treatment of shingles (varicella zoster virus infection) in immune competent patients who show very severe acute local or systemic manifestations of the disease. benefits can be expected in patients with rash duration shorter than 72 hours. the use of the intravenous infusion may be warranted in only a small subgroup of immune competent patients with shingles.,5. treatment of herpes simplex encephalitis.

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

accord healthcare pty ltd - aciclovir, quantity: 25 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; hydrochloric acid; water for injections - aciclovir intravenous infusion is indicated for the purpose of:,1. promoting resolution of acute clinical manifestations of mucocutaneous herpes simplex virus infections in immunocompromised patients.,2. treatment of severe first episode primary or non-primary genital herpes in immune competent patients.,3. treatment of acute manifestations of varicella zoster virus infection in immunocompromised patients.,4. treatment of shingles (varicella zoster virus infection) in immune competent patients who show very severe acute local or systemic manifestations of the disease. benefits can be expected in patients with rash duration shorter than 72 hours. the use of the intravenous infusion may be warranted in only a small subgroup of immune competent patients with shingles.,5. treatment of herpes simplex encephalitis.

Israel - English - Ministry of Health

j-c health care ltd - haloperidol - solution for injection - haloperidol 5 mg/ml - haloperidol - haldol solution for injection is indicated in adult patients for:* rapid control of severe acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar i disorder when oral therapy is not appropriate.* acute treatment of delirium in patient suffering from severe agitation that may harm the patient, when non-pharmacological treatments have failed.* treatment of mild to moderate chorea in huntington’s disease, when other medicinal products are ineffective or not tolerated, and oral therapy is not appropriate.* single or combination prophylaxis in patients at moderate to high risk of postoperative nausea and vomiting, when other medicinal products are ineffective or not tolerated.* combination treatment of postoperative nausea and vomiting when other medicinal products are ineffective or not nausea and vomiting when other medicinal products are ineffective or not tolerated.

Israel - English - Ministry of Health

j-c health care ltd - ibrutinib - film coated tablets - ibrutinib 140 mg - ibrutinib - • mantle cell lymphoma:imbruvica is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy.• chronic lymphocytic leukemia/small lymphocytic lymphoma :imbruvica is indicated for the treatment of adult patients, with chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll)• chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion:imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion.• waldenström’s macroglobulinemiaimbruvica is indicated for the treatment of adult patients with waldenström’s macroglobulinemia (wm).• marginal zone lymphomaimbruvica is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who require systemic therapy and have received at least one prior anti-cd20-based therapy.• chronic graft versus host diseaseimbruvica is indicated for the treatment of adult patients with chronic graft-versus-host disease (cgvhd) after failure of one or more lines of systemic therapy.

Israel - English - Ministry of Health

j-c health care ltd - ibrutinib - film coated tablets - ibrutinib 280 mg - ibrutinib - • mantle cell lymphoma:imbruvica is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy.• chronic lymphocytic leukemia/small lymphocytic lymphoma :imbruvica is indicated for the treatment of adult patients, with chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll)• chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion:imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion.• waldenström’s macroglobulinemiaimbruvica is indicated for the treatment of adult patients with waldenström’s macroglobulinemia (wm).• marginal zone lymphomaimbruvica is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who require systemic therapy and have received at least one prior anti-cd20-based therapy.• chronic graft versus host diseaseimbruvica is indicated for the treatment of adult patients with chronic graft-versus-host disease (cgvhd) after failure of one or more lines of systemic therapy.

Israel - English - Ministry of Health

j-c health care ltd - ibrutinib - film coated tablets - ibrutinib 420 mg - ibrutinib - • mantle cell lymphoma:imbruvica is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy.• chronic lymphocytic leukemia/small lymphocytic lymphoma :imbruvica is indicated for the treatment of adult patients, with chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll)• chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion:imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion.• waldenström’s macroglobulinemiaimbruvica is indicated for the treatment of adult patients with waldenström’s macroglobulinemia (wm).• marginal zone lymphomaimbruvica is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who require systemic therapy and have received at least one prior anti-cd20-based therapy.• chronic graft versus host diseaseimbruvica is indicated for the treatment of adult patients with chronic graft-versus-host disease (cgvhd) after failure of one or more lines of systemic therapy.

Israel - English - Ministry of Health

j-c health care ltd - ibrutinib - film coated tablets - ibrutinib 560 mg - ibrutinib - • mantle cell lymphoma:imbruvica is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy.• chronic lymphocytic leukemia/small lymphocytic lymphoma :imbruvica is indicated for the treatment of adult patients, with chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll)• chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion:imbruvica is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) /small lymphocytic lymphoma (sll) with 17p deletion.• waldenström’s macroglobulinemiaimbruvica is indicated for the treatment of adult patients with waldenström’s macroglobulinemia (wm).• marginal zone lymphomaimbruvica is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who require systemic therapy and have received at least one prior anti-cd20-based therapy.• chronic graft versus host diseaseimbruvica is indicated for the treatment of adult patients with chronic graft-versus-host disease (cgvhd) after failure of one or more lines of systemic therapy.