Európska únia - angličtina - EMA (European Medicines Agency)

csl behring gmbh - human normal immunoglobulin (scig) - immunologic deficiency syndromes - immune sera and immunoglobulins, - replacement therapy in adults, children and adolescents (0-18 years) in:- primary immunodeficiency syndromes with impaired antibody production (see section 4.4).- secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of

Európska únia - angličtina - EMA (European Medicines Agency)

csl behring gmbh - albutrepenonacog alfa - hemophilia b - antihemorrhagics - treatment and prophylaxis of bleeding in patients with haemophilia b (congenital factor ix deficiency).

Európska únia - angličtina - EMA (European Medicines Agency)

csl behring gmbh - alpha1-proteinase inhibitor (human) - genetic diseases, inborn, lung diseases - antihemorrhagics, - respreeza is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes pizz, piz(null), pi(null,null), pisz). patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (fev1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.,

Európska únia - angličtina - EMA (European Medicines Agency)

csl behring gmbh - lonoctocog alfa - hemophilia a - antihemorrhagics - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency).afstyla can be used for all age groups.

Európska únia - angličtina - EMA (European Medicines Agency)

csl behring gmbh - human normal immunoglobulin (ivig) - purpura, thrombocytopenic, idiopathic; bone marrow transplantation; immunologic deficiency syndromes; guillain-barre syndrome; mucocutaneous lymph node syndrome - immune sera and immunoglobulins, - replacement therapy in adults, and children and adolescents (0-18 years) in:primary immunodeficiency (pid) syndromes with impaired antibody production;hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed;hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who have failed to respond to pneumococcal immunisation;hypogammaglobulinaemia in patients after allogeneic haematopoietic-stem-cell transplantation (hsct);congenital aids with recurrent bacterial infections.immunomodulation in adults, and children and adolescents (0-18 years) in:primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;guillain-barré syndrome;kawasaki disease;chronic inflammatory demyelinating polyneuropathy (cidp). only limited experience is available of use of intravenous immunoglobulins in children with cidp.

Európska únia - angličtina - EMA (European Medicines Agency)

csl behring gmbh - human coagulation factor viii, human von willebrand factor - hemophilia a; von willebrand diseases - blood coagulation factors, von willebrand factor and coagulation factor viii in combination, antihemorrhagics - von willebrand disease (vwd)prophylaxis and treatment of haemorrhage or surgical bleeding in patients with vwd, when desmopressin (ddavp) treatment alone is ineffective or contraindicated.haemophilia a (congenital factor-viii deficiency)prophylaxis and treatment of bleeding in patients with haemophilia a.

Európska únia - angličtina - EMA (European Medicines Agency)

csl behring gmbh - etranacogene dezaparvovec - hemophilia b - other hematological agents - treatment of severe and moderately severe haemophilia b (congenital factor ix deficiency) in adult patients without a history of factor ix inhibitors.

Malta - angličtina - Medicines Authority

apta medica internacional d.o.o likozarjeva ulica 6, 1000 ljubljana, , slovenia - amoxicillin, clavulanic acid - powder for solution for infusion or injection - amoxicillin 1000 mg clavulanic acid 200 mg - antibacterials for systemic use

Malta - angličtina - Medicines Authority

apta medica internacional d.o.o likozarjeva ulica 6, 1000 ljubljana, , slovenia - imipenem, cilastatin - powder for solution for infusion - imipenem 500 mg cilastatin 500 mg - antibacterials for systemic use

Malta - angličtina - Medicines Authority

apta medica internacional d.o.o likozarjeva ulica 6, 1000 ljubljana, , slovenia - ertapenem sodium - concentrate for solution for infusion - ertapenem sodium 1 g - antibacterials for systemic use