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

csl behring australia pty ltd - human immunoglobulin g, quantity: 200 g/l - injection - excipient ingredients: polysorbate 80; proline; hydrochloric acid; sodium hydroxide; water for injections - 1 indications and usage hizentra is an immune globulin subcutaneous (human) (igsc), 20% liquid indicated for the treatment of the following conditions: 1.1 primary immunodeficiency (pi) hizentra is indicated as replacement therapy for primary humoral immunodeficiency (pi) in adults and pediatric patients 2 years of age and older. this includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, x-linked agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. 1.2 chronic inflammatory demyelinating polyneuropathy (cidp) hizentra is indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. limitations of use: hizentra maintenance therapy in cidp has been systematically studied for 6 months and for a further 12 months in a follow-up study. maintenance therapy beyond these periods should be individualized based upon the patient?s response and need for continued therapy [see dosage and administration (2)].

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

intervet international b.v. - cefquinome sulfate - suspension for injection - 7,5 % - cefquinome sulfate - cefquinome - cattle

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

intervet international b.v, netherlands - cefquinome sulphate - suspension for injection - 25 mg/ml

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

kyowa kirin malaysia sdn. bhd. - brodalumab -

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

smiths medical australasia pty ltd - 17180 - needle, subcutaneous injection/infusion port - the huber needle infusion set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port.

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

becton dickinson pty ltd - 61650 - peripheral vascular/subcutaneous catheter - intended to be inserted into a patient's peripheral vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids; or for subcutaneous administration of fluids and medications. these devices may be used for any patient population with consideration given to adequacy of vascular anatomy or subcutaneous tissue, appropriateness for solutions being infused and duration of therapy.

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

epic medical pty ltd - 17180 - needle, subcutaneous injection/infusion port - the safety subcutaneous infusion set consists of a needle, tubing and syringe port, connected as a system to enable subcutaneous infusion of medication administered by an external infusion device.

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

clinect pty ltd - 17180 - needle, subcutaneous injection/infusion port - manufacturer's intended purpose: infusion port for subcutaneous administration of a medicine

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

medtronic australasia pty ltd - 17180 - needle, subcutaneous injection/infusion port - the i-port advance? injection port is indicated for patients who administer, or to whom is administered, multiple daily subcutaneous injections of physician prescribed medications, including insulin.

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

convatec australia pty ltd - 17180 - needle, subcutaneous injection/infusion port - infusion port for subcutaneous administration of a medicine.