Malta - English - Medicines Authority

hetero europe s.l. viladecans business park - edificio brasil catalunya 83-85 08840 viladecans, spain - temozolomide - hard capsule - temozolomide 20 mg - antineoplastic agents

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

hetero australia pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg - tablet - excipient ingredients: microcrystalline cellulose; pregelatinised maize starch; croscarmellose sodium; lactose monohydrate; magnesium stearate; titanium dioxide; hypromellose; triacetin - tenofovir hetero in combination with other antiretroviral agents is indicated for the treatment of hiv-infected adults and paediatric patients 12 years of age and older.,tenofovir hetero is indicated for the treatment of chronic hepatitis b in adults (see clinical trials)..,tenofovir hetero is indicated for the treatment of chronic hepatitis b in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e, active viral replication, persistently elevated serum alt levels or evidence of active inflammation.

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

hetero australia pty ltd - tenofovir disoproxil fumarate, quantity: 300 mg - tablet - excipient ingredients: microcrystalline cellulose; magnesium stearate; croscarmellose sodium; lactose monohydrate; pregelatinised maize starch; titanium dioxide; hypromellose; triacetin - tenofovir hetero in combination with other antiretroviral agents is indicated for the treatment of hiv-infected adults and paediatric patients 12 years of age and older.,tenofovir hetero is indicated for the treatment of chronic hepatitis b in adults (see clinical trials).,tenofovir hetero is indicated for the treatment of chronic hepatitis b in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e, active viral replication, persistently elevated serum alt levels or evidence of active inflammation.

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

hetero australia pty ltd - valganciclovir, quantity: 450 mg - tablet, film coated - excipient ingredients: povidone; stearic acid; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; polysorbate 80; iron oxide red; macrogol 400 - valganciclovir is indicated for the treatment of cytomegalovirus (cmv) retinitis in patients with acquired immunodeficiency syndrome (aids). valganciclovir is indicated for the prophylaxis of cmv infection and disease following solid organ transplantation in patients at risk of cmv disease.

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

hetero australia pty ltd - bortezomib, quantity: 3.5 mg - injection, powder for - excipient ingredients: mannitol - bortezomib hetero in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. bortezomib hetero as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. bortezomib hetero is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. bortezomib hetero in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

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

tern yun holdings sdn bhd - epimedium sagittatum; poria cocos wolf; fructus schisandrae chinense; eucommia ulmoides stem; herba leonurus heterophyclus -

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

hetero drugs south africa (pty) ltd - tablet - see ingredients - each tablet contains tenofovir disoproxil fumarate 300,0 mg

Namibia - English - Namibia Medicines Regulatory Council

hetero labs limited - emtricitabine; tenofovir df - tablets - each tablet contains; emtricitabine 200,0 mg, tenofovir disproxil fumarate 300,0 mg

Namibia - English - Namibia Medicines Regulatory Council

hetero labs limites - abacavir - tablets - each tablet contains; abacavir sulfate equivalent to abacavir 300,0 mg

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

hetero australia pty ltd - gemcitabine hydrochloride, quantity: 1138 mg - injection, powder for - excipient ingredients: mannitol; sodium acetate trihydrate; sodium hydroxide - gemcitabine is indicated for treatment of patients with locally advanced or metastatic non- small cell lung cancer.,gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. gemcitabine is also indicated for patients with 5-fu refractory pancreatic cancer.,gemcitabine, alone or in combination with cisplatin, is indicated for treatment of patients with bladder cancer.,gemcitabine, in combination with paclitaxel, is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated.,gemcitabine, in combination with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma, who have relapsed > 6 months following platinum? based therapy