European Union - English - EMA (European Medicines Agency)

n.v. organon - follitropin beta - infertility; hypogonadism - sex hormones and modulators of the genital system, - in the female:puregon is indicated for the treatment of female infertility in the following clinical situations:anovulation (including polycystic ovarian syndrome, pcos) in women who have been unresponsive to treatment with clomifene citrate;controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs (e.g. in-vitro fertilisation / embryo transfer (ivf/et), gamete intrafallopian transfer (gift) and intracytoplasmic sperm injection (icsi)).in the male:deficient spermatogenesis due to hypogonadotrophic hypogonadism.

European Union - English - EMA (European Medicines Agency)

hospira uk limited - docetaxel trihydrate - stomach neoplasms; prostatic neoplasms; breast neoplasms; head and neck neoplasms; carcinoma, non-small-cell lung - antineoplastic agents - breast cancertaxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.for patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.taxespira in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.taxespira monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. previous chemotherapy should have included an anthracycline or an alkylating agent.taxespira combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express her2 and who previously have not received chemotherapy for metastatic disease.taxespira in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. previous therapy should have included an anthracycline.non-small cell lung cancer taxespira indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.taxespira in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.prostate cancer taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.gastric adenocarcinoma taxespira in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.head and neck cancer taxespira in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

European Union - English - EMA (European Medicines Agency)

theravance biopharma ireland umited - telavancin - pneumonia, bacterial; cross infection - antibacterials for systemic use, - vibativ is indicated for the treatment of adults with nosocomial pneumonia including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant staphylococcus aureus (mrsa).vibativ should be used only in situations where it is known or suspected that other alternatives are not suitable.consideration should be given to official guidance on the appropriate use of antibacterial agents.

European Union - English - EMA (European Medicines Agency)

merck sharp and dohme b.v - ribavirin - hepatitis c, chronic - antivirals for systemic use, antivirals for treatment of hcv infections - rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adults.rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation.

European Union - English - EMA (European Medicines Agency)

cis bio international  - besilesomab - osteomyelitis; radionuclide imaging - diagnostic radiopharmaceuticals - this medicinal product is for diagnostic use only and the approved indication is scintigraphic imaging, in conjunction with other appropriate imaging modalities, for determining the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis. scintimun should not be used for the diagnosis of diabetic foot infection.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

axichem pty ltd - triadimenol; n-methyl-2-pyrrolidone - emulsifiable concentrate - triadimenol triazole active 250.0 g/l; n-methyl-2-pyrrolidone solvent other 600.0 g/l - fungicide

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

axichem pty ltd - quizalofop-p-ethyl; n-methylpyrrolidone; liquid hydrocarbon - emulsifiable concentrate - quizalofop-p-ethyl phenoxy acids-propionics active 200.0 g/l; n-methylpyrrolidone solvent other 150.0 g/l; liquid hydrocarbon solvent other 592.0 g/l - herbicide

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

axichem pty ltd - diflufenican; bromoxynil present as the octanoate; n-methyl-2-pyrrolidone; liquid hydrocarbon - emulsifiable concentrate - diflufenican anilide/aniline-nicotinanilide active 25.0 g/l; bromoxynil present as the octanoate nitrile active 250.0 g/l; n-methyl-2-pyrrolidone solvent other 150.0 g/l; liquid hydrocarbon solvent other 416.0 g/l - herbicide

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - dutasteride 0.5mg - soft gelatin capsule - 500 mcg - active: dutasteride 0.5mg excipient: butylated hydroxytoluene gelatin glycerol iron oxide red iron oxide yellow octanoic/decanoic acid glycerides titanium dioxide - terod is indicated for the treatment of, and to prevent progression of benign prostatic hyperplasia (bph) by reducing prostate size, alleviating symptoms, improving urinary flow and reducing the risk of acute urinary retention (aur) and the need for bph related surgery. terod is indicated for use as combination therapy in the management of symptomatic bph with an alpha blocker which is approved for use in bph and which has been dose titrated in accordance with the relevant recommendation in the product information for that alpha blocker.

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

chiesi australia pty ltd - deferiprone, quantity: 1000 mg - tablet, film coated - excipient ingredients: crospovidone; magnesium stearate; hypromellose; hyprolose; macrogol 8000; titanium dioxide; methylcellulose - ferriprox is indicated for the treatment of iron overload in patients with thalassaemia major who are unable to take desferrioxamine or in whom desferrioxamine therapy has proven ineffective.