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

interpharma pty ltd - dexmedetomidine hydrochloride, quantity: 472.8 microgram (equivalent: dexmedetomidine, qty 400 microgram) - injection, concentrated - excipient ingredients: sodium chloride; water for injections - icu sedation.,for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine ever pharma by continuous infusion in these patients should not exceed 24 hours.,procedural sedation,for sedation of non-intubated patients prior to and/or during surgical and other procedures.

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

interpharma pty ltd - bortezomib, quantity: 3.5 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections; mannitol - bortezomib ever pharma, 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 ever pharma, 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 ever pharma is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. bortezomib ever pharma 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)

interpharma pty ltd - bortezomib, quantity: 2.5 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; sodium hydroxide; water for injections; mannitol - bortezomib ever pharma, 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 ever pharma, 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 ever pharma is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. bortezomib ever pharma in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Ireland - English - HPRA (Health Products Regulatory Authority)

advanz pharma limited - eribulin mesylate - solution for injection - eribulin

European Union - English - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - umeclidinium bromide - pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (copd).,

Canada - English - Health Canada

merz pharmaceuticals gmbh - incobotulinumtoxina - powder for solution - 100unit - incobotulinumtoxina 100unit - other miscellaneous therapeutic agents

Canada - English - Health Canada

merz pharmaceuticals gmbh - incobotulinumtoxina - powder for solution - 50unit - incobotulinumtoxina 50unit - other miscellaneous therapeutic agents

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - umeclidinium bromide - inhalation powder - 65microgram/1dose

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - fexofenadine hydrochloride 120mg;  ;   - film coated tablet - 120 mg - active: fexofenadine hydrochloride 120mg     excipient: colloidal silicon dioxide croscarmellose sodium ferric oxide, pink hypromellose e-15 hypromellose e-5 iron oxide yellow macrogol 400 magnesium stearate microcrystalline cellulose povidone pregelatinised maize starch titanium dioxide - relief of symptoms associated with seasonal allergic rhinitis and allergic rhinitis in adults and children from 2 years of age.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - fexofenadine hydrochloride 180mg;  ;   - film coated tablet - 180 mg - active: fexofenadine hydrochloride 180mg     excipient: colloidal silicon dioxide croscarmellose sodium ferric oxide, pink hypromellose e-15 hypromellose e-5 iron oxide yellow macrogol 400 magnesium stearate microcrystalline cellulose povidone pregelatinised maize starch titanium dioxide - relief of symptoms associated with seasonal allergic rhinitis and allergic rhinitis in adults and children from 2 years of age.