Philippines - English - FDA (Food And Drug Administration)

schering-plough labo., n.v. - belgium; importer: merck sharp & dohme (i.a.) corp.; distributor: merck sharp & dohme (i.a.) corp. - boceprevir - capsule - 200mg

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - asenapine as maleate - tablets sublingual - asenapine as maleate 5 mg - asenapine - asenapine - schizophrenia saphris is indicated for the treatment of schizophrenia in adults. the efficacy of saphris was established in two 6-week trials and one maintenance trial in adults bipolar disorder monotherapy: saphris is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder. efficacy was established in two 3-week monotherapy trials in adults adjunctive therapy: saphris is indicated as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar i disorder. efficacy was established in one 3-week adjunctive trial in adults.

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - asenapine as maleate - tablets sublingual - asenapine as maleate 10 mg - asenapine - asenapine - schizophrenia saphris is indicated for the treatment of schizophrenia in adults. the efficacy of saphris was established in two 6-week trials and one maintenance trial in adults bipolar disorder monotherapy: saphris is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder. efficacy was established in two 3-week monotherapy trials in adults adjunctive therapy: saphris is indicated as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar i disorder. efficacy was established in one 3-week adjunctive trial in adults.

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

merck sharp & dohme (australia) pty ltd - temozolomide, quantity: 250 mg - capsule, hard - excipient ingredients: sodium lauryl sulfate; lactose; stearic acid; gelatin; titanium dioxide; sodium starch glycollate; tartaric acid; colloidal anhydrous silica; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; ethanol; shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide - temodal capsules are indicated for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment; recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy. temodal capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma.

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

merck sharp & dohme (australia) pty ltd - temozolomide, quantity: 100 mg - capsule, hard - excipient ingredients: tartaric acid; sodium lauryl sulfate; iron oxide red; lactose; colloidal anhydrous silica; stearic acid; gelatin; sodium starch glycollate; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; ethanol; shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide - temodal capsules are indicated for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment; recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy. temodal capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma.

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

merck sharp & dohme (australia) pty ltd - temozolomide, quantity: 20 mg - capsule, hard - excipient ingredients: tartaric acid; colloidal anhydrous silica; iron oxide yellow; gelatin; lactose; sodium lauryl sulfate; stearic acid; titanium dioxide; sodium starch glycollate; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; ethanol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; simethicone - temodal capsules are indicated for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment; recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy. temodal capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma.

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

merck sharp & dohme (australia) pty ltd - temozolomide, quantity: 5 mg - capsule, hard - excipient ingredients: indigo carmine; sodium lauryl sulfate; tartaric acid; iron oxide yellow; lactose; colloidal anhydrous silica; sodium starch glycollate; gelatin; stearic acid; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; ethanol; shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide - temodal capsules are indicated for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment; recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy. temodal capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma.

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - eptifibatide - solution for infusion - eptifibatide 0.75 mg/ml - eptifibatide - eptifibatide - integrilin is indicated for the prevention of death and myocardial infarction in patients presenting with high risk unstable angina or non-q-wave myocardial infarction. integrilin is indicated in patients who are managed with standard medical therapies and/or with percutaneous coronary intervention. integrilin is also indicated as an adjunct to percutaneous transluminal coronary angioplasty (ptca) balloon angioplasty, directional atheretomy, transluminal extraction catheter atherectomy, rotational ablation angioplasty, or excimer laser angioplasty for the prevention of abrupt closure of the treated coronary vessel and related acute ischemic cardiac complications (death, myorardial infarction, need for urgent intervention). integrilin is intended for use with aspirin and heparin.

Israel - English - Ministry of Health

merck sharp & dohme (israel - 1996) company ltd, israel - eptifibatide - solution for injection - eptifibatide 2 mg/ml - eptifibatide - eptifibatide - integrilin is indicated for the prevention of death and myocardial infarction in patients presenting with high risk unstable angina or non-q-wave myocardial infarction. integrilin is indicated in patients who are managed with standard medical therapies and/or with percutaneous coronary intervention. integrilin is also indicated as an adjunct to percutaneous transluminal coronary angioplasty (ptca) balloon angioplasty, directional atheretomy, transluminal extraction catheter atherectomy, rotational ablation angioplasty, or excimer laser angioplasty for the prevention of abrupt closure of the treated coronary vessel and related acute ischemic cardiac complications (death, myorardial infarction, need for urgent intervention). integrilin is intended for use with aspirin and heparin.

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - posaconazole 18 mg/ml;   - concentrate for injection - 300mg/16.7ml - active: posaconazole 18 mg/ml   excipient: disodium edetate hydrochloric acid sodium hydroxide sulfobutyl betadex sodium water for injection - noxafil (posaconazole) concentrated injection is indicated for use in the treatment of the following invasive fungal infections in adults: - invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy. - fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy. noxafil is also indicated for the: - prophylaxis of invasive fungal infections among adults, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (hsct) recipients.