Canada - English - Health Canada

taro pharmaceuticals inc - bortezomib (bortezomib mannitol boronic ester) - powder for solution - 3.5mg - bortezomib (bortezomib mannitol boronic ester) 3.5mg - antineoplastic agents

Canada - English - Health Canada

taro pharmaceuticals inc - bortezomib (bortezomib mannitol boronic ester) - powder for solution - 2.5mg - bortezomib (bortezomib mannitol boronic ester) 2.5mg - antineoplastic agents

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

sandoz pty ltd - bortezomib, quantity: 3.5 mg - injection, powder for - excipient ingredients: mannitol - bortezomib sandoz, 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 sandoz, 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 sandoz is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib sandoz in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - bortezomib 3.5mg (as a bortezomib mannitol boronic ester) - powder for injection - 3.5 mg - active: bortezomib 3.5mg (as a bortezomib mannitol boronic ester) excipient: mannitol nitrogen - bortezomib mylan in combination with melphalan and prednisone, is indicated for the treatment of patients with previously untreated multiple myeloma, who are not suitable for high dose chemotherapy. bortezomib mylan 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 mylan is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.

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

fresenius kabi usa, llc - bortezomib (unii: 69g8bd63pp) (bortezomib - unii:69g8bd63pp) - bortezomib 1 mg in 1 ml - bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma. bortezomib for injection is indicated for the treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy. bortezomib for injection is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, boric acid or glycine. reactions have included anaphylactic reactions [see adverse reactions (6.1)] . bortezomib for injection is contraindicated for intrathecal administration. fatal events have occurred with intrathecal administration of bortezomib. risk summary based on its mechanism of action [see clinical pharmacology (12.1)] and findings in animals, bortezomib for injection can cause fetal harm when administered to a pregnant woman. there are no studies with the use of bortezomib in pregnant women to inform drug-associated risks. bortezomib caused embryo-fetal lethality in rabbits at doses lower than the clinical dose [see data] . advis

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - bortezomib 3.5mg (as a bortezomib mannitol ester that is formed during fp manufacture.) - powder for injection - 3.5 mg - active: bortezomib 3.5mg (as a bortezomib mannitol ester that is formed during fp manufacture.) excipient: mannitol - velcade in combination with melphalan and prednisone, is indicated for the treatment of patients with previously untreated multiple myeloma, who are not suitable for high dose chemotherapy. velcade 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. velcade is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.

Canada - English - Health Canada

taro pharmaceuticals inc - bortezomib (bortezomib mannitol boronic ester) - powder for solution - 1mg - bortezomib (bortezomib mannitol boronic ester) 1mg - antineoplastic agents

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - bortezomib - powder for solution for injection - bortezomib 3.5 mg - antineoplastic agents

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

juno pharmaceuticals pty ltd - bortezomib, quantity: 3.5 mg - injection, powder for - excipient ingredients: nitrogen; mannitol - bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection), 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 juno (bortezomib 1 mg and 3.5 mg powder for injection), 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 juno (bortezomib 1 mg and 3.5 mg powder for injection) is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection) in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

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

juno pharmaceuticals pty ltd - bortezomib, quantity: 1 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection), 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 juno (bortezomib 1 mg and 3.5 mg powder for injection), 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 juno (bortezomib 1 mg and 3.5 mg powder for injection) is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,bortezomib juno (bortezomib 1 mg and 3.5 mg powder for injection) in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.