Product Registration 2015/161

Therapy area Product Country/region

Immunoglobulins

Focus on improved patient convenience, yield improvements, expanded labels, new formulation science and specialty immunoglobulins

TETAGAM®, human tetanus immunoglobulin.

Armenia, Azerbaijan

HIZENTRA, 20% subcutaneous immunoglobulin, for treatment of primary immunodeficiencies, myeloma and chronic lymphocytic leukaemia.

Brazil

PRIVIGEN®, 10% intravenous immunoglobulin, for treatment of patients with chronic inflammatory demyelinating polyneuropathy.

Kazakhstan

RHOPHYLAC®, for prevention of Rh(D) immunisation in Rh(D)-negative women, prevention of Rh(D) immunisation in Rh(D)-negative persons given incompatible transfusions of Rh(D)-positive blood or other products containing Rh(D)-positive red blood cells.

Kazakhstan

Haemophilia and coagulation products

Support and enhance plasma products and develop a novel recombinant portfolio with a focus on scientific and product innovation and patient benefit

AFSTYLA, antihaemophilic factor (recombinant), single chain, indicated in adults and children with haemophilia A.

US

BERIATE®, coagulation factor VIII, for treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

This product may be used in the management of acquired factor VIII deficiency.

Hong Kong,

Portugal (BERIATE 2000 IU)

HAEMATE® P, coagulation factor VIII/von Willebrand factor (human), for the treatment of von Willebrand disease (VWD), and for prophylaxis and treatment of haemorrhage or surgical bleeding, when desmopressin (DDAVP) treatment alone is ineffective or contraindicated. Also for the treatment of haemophilia A (congenital factor VIII deficiency) and prophylaxis and treatment of bleeding in patients with haemophilia A.

Armenia, Hong Kong, Uruguay

IDELVION, coagulation factor IX (recombinant), albumin fusion protein (rIX-FP), a recombinant human blood coagulation factor, indicated in children and adults with haemophilia B (congenital Factor IX deficiency).

Canada, European Union, US

CLUVOT®, coagulation factor XIII (human), for treatment of adult and paediatric patients.

Luxembourg, Mexico

VONCENTO®, coagulation factor VIII/von Willebrand factor (human), for prevention and treatment of bleeding in haemophilia A and von Willebrand disease.

Australia, European Union, Switzerland

MONONINE®, coagulation factor IX (human), for treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).

Armenia, Iran, Kazakhstan

Specialty products

Leverage our high quality, broad specialty plasma products portfolio through new markets, novel indications and new modes of administration

ALBUMEON®, albumin (human), for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate.

Austria, Finland, Greece, Slovenia, Spain

BERINERT 1500®, C1-esterase inhibitor (human), for treatment and pre-procedure prevention of acute attacks of HAE type I and type II.

Luxembourg, Romania, Spain, Sweden

BERINERT 500 and 1500®, C1-esterase inhibitor (human), for treatment and pre-procedure prevention of acute attacks of HAE type I and type II.

Macedonia

ALBUNATE® 5, 20 & 25, albumin (human), for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate.

Australia

Albumin (human) 5/20/25% solution, for restoration and maintenance of circulating blood volume.

Australia, Hong Kong, Myanmar, Trinidad and Tobago, US (ALBURX 20%)

RESPREEZA®, alpha-1-proteinase inhibitor (human), indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha-1-proteinase inhibitor deficiency.

European Union, Switzerland

ZEMAIRA®, alpha-1-proteinase inhibitor (human), for chronic augmentation and maintenance therapy in subjects with alpha-1- proteinase inhibitor deficiency and clinical evidence of emphysema.

Mexico

BERIPLEX P/N 250, 500 and 1000 IU, prothrombin complex (human), for treatment and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors. Also for treatment and perioperative prophylaxis of bleeding in congenital deficiency of any of the vitamin K dependent coagulation factors when purified specific coagulation factor products are not available.

Brazil (1000 IU), Bulgaria, Croatia, Czech Republic, Denmark, El Salvador, Iran, Ireland, Malta, Romania, Russia, Slovakia, Slovenia

Vaccines and licensing

Supporting products for the prevention of infectious diseases and partnering our intellectual property

FLUAD paediatric, MF59-adjuvanted egg-based subunit trivalent seasonal influenza vaccine for children aged 6–24 months.

Canada

FLUAD elderly, MF59-adjuvanted egg-based subunit trivalent seasonal influenza vaccine for adults aged ≥65 years.

US

FLUCELVAX, seasonal cell culture-based subunit trivalent influenza vaccine for ages 4+ years.

US

FLUCELVAX QUAD, seasonal cell culture-based subunit quadrivalent influenza vaccine for ages 4+ years.

US

AFLURIA QUAD, seasonal egg-based split quadrivalent influenza vaccine for adults aged 18+ years.

Australia, US

1 First-time registrations or indications for CSL products in the listed countries/regions over the reporting period.