European Union - English - EMA (European Medicines Agency)

ascendis pharma endocrinology division a/s - lonapegsomatropin - growth and development - pituitary and hypothalamic hormones and analogues - growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [ghd]),

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

link medical products pty ltd t/a link pharmaceuticals - dapsone -

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

link medical products pty ltd t/a link pharmaceuticals - phenelzine sulfate -

New Zealand - English - Medsafe (Medicines Safety Authority)

link pharmaceuticals ltd - hydroxycarbamide 500mg;   - capsule - 500 mg - active: hydroxycarbamide 500mg   excipient: citric acid dibasic sodium phosphate dodecahydrate erythrosine gelatin   indigo carmine iron oxide yellow lactose monohydrate magnesium stearate opacode black s-1-277002 titanium dioxide   - significant tumour response to hydrea (hydroxyurea) has been demonstrated in chronic myelocytic leukaemia (pretreatment phase and palliative care) and recurrent metastatic or inoperable carcinoma of the ovary. hydrea used concomitantly with irradiation therapy is intended for use in the local control of primary squamous cell (epidermoid) carcinomas of the head and neck, excluding the lip, and carcinoma of the cervix.

Malta - English - Medicines Authority

aristo pharma gmbh wallenroder straße 8–10, 13435, berlin, germany - tadalafil - film-coated tablet - tadalafil 5 mg - urologicals

Malta - English - Medicines Authority

aristo pharma gmbh wallenroder straße 8–10, 13435, berlin, germany - tadalafil - film-coated tablet - tadalafil 10 mg - urologicals

Malta - English - Medicines Authority

aristo pharma gmbh wallenroder straße 8–10, 13435, berlin, germany - tadalafil - film-coated tablet - tadalafil 20 mg - urologicals

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

idaman pharma manufacturing sdn bhd - prednisolone -

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

idaman pharma manufacturing sdn bhd - gliclazide -

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.