Filsuvez Unjoni Ewropea - Malti - EMA (European Medicines Agency)

filsuvez

amryt pharmaceuticals dac - dry extract from birch bark (der 5-10 : 1), extraction solvent n-heptane 95% (w/w) - epidermolysis bullosa dystrophica; epidermolysis bullosa, junctional - preparazzjonijiet għat-trattament ta 'feriti u ulċeri - treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (eb) in patients 6 months and older.

Episalvan Unjoni Ewropea - Malti - EMA (European Medicines Agency)

episalvan

amryt ag - betulae cortex - wounds and injuries; wound healing - preparazzjonijiet għat-trattament ta 'feriti u ulċeri - trattament ta 'feriti ta' ħxuna parzjali fl-adulti. ara t-taqsimiet 4. 4 u 5. 1 fl-informazzjoni dwar il-prodott fir-rigward tat-tip ta 'feriti studjati.

CaniLeish Unjoni Ewropea - Malti - EMA (European Medicines Agency)

canileish

virbac s.a. - leishmania infantum tneħħiet il-proteini mneħħija - immunoloġiċi - klieb - għall-immunizzazzjoni attiva ta 'klieb negattivi leishmania minn sitt xhur ta' età biex tnaqqas ir-riskju li tiżviluppa infezzjoni attiva u mard kliniku wara kuntatt ma 'leishmania infantum. l-effikaċja tal-vaċċin intweriet fi klieb sottomessi għal espożizzjoni multipla ta 'parassiti naturali f'żoni b'piżjoni għolja ta' infezzjoni. il-bidu tal-immunità: 4 ġimgħat wara l-kors primarju ta 'tilqim. tul ta 'żmien tal-immunità: sena wara l-aħħar tilqima mill-ġdid.

Plerixafor Accord Unjoni Ewropea - Malti - EMA (European Medicines Agency)

plerixafor accord

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - immunostimulanti, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4. paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.

Flebogamma DIF (previously Flebogammadif) Unjoni Ewropea - Malti - EMA (European Medicines Agency)

flebogamma dif (previously flebogammadif)

instituto grifols s.a. - l-immunoglobulina normali umana - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - sera immuni u immunoglobulini, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, 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.

Carmustine medac (previously Carmustine Obvius) Unjoni Ewropea - Malti - EMA (European Medicines Agency)

carmustine medac (previously carmustine obvius)

medac gesellschaft für klinische spezialpräparate mbh - carmustine - hodgkin disease; lymphoma, non-hodgkin - aġenti antineoplastiċi - carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): , brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases, secondary therapy in non-hodgkin’s lymphoma and hodgkin’s disease, as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (hpct) in malignant haematological diseases (hodgkin’s disease / non-hodgkin’s lymphoma).

Upstaza Unjoni Ewropea - Malti - EMA (European Medicines Agency)

upstaza

ptc therapeutics international limited - eladocagene exuparvovec - amino acid metaboliżmu, Żbalji inborn - enzymes, other alimentary tract and metabolism products - upstaza is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic l amino acid decarboxylase (aadc) deficiency with a severe phenotype (see section 5.

Rasilez Unjoni Ewropea - Malti - EMA (European Medicines Agency)

rasilez

noden pharma dac - aliskiren - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta 'ipertensjoni essenzjali.

Rasilamlo Unjoni Ewropea - Malti - EMA (European Medicines Agency)

rasilamlo

novartis europharm ltd - aliskiren, amlodipine - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - rasilamlo huwa indikat għat-trattament ta 'pressjoni għolja essenzjali f'pazjenti adulti li l-pressjoni tad-demm tagħhom mhix ikkontrollata b'mod adegwat b'aliskiren jew amlodipine użat waħdu.

Rasilez HCT Unjoni Ewropea - Malti - EMA (European Medicines Agency)

rasilez hct

noden pharma dac - aliskiren, għall-idroklorotijażide - pressjoni għolja - aġenti li jaġixxu fuq is-sistema renin-angiotensin - trattament ta 'pressjoni għolja essenzjali fl-adulti. rasilez hct huwa indikat f'pazjenti li l-pressjoni tad-demm ma tkunx ikkontrollata sew b'aliskiren jew hydrochlorothiazide użati waħidhom. rasilez hct huwa indikat bħala terapija ta 'sostituzzjoni f'pazjenti li jkunu kontrollati sew b'aliskiren u hydrochlorothiazide, mogħtija flimkien, bl-istess livell ta' doża tat - taħlita.