Tecovirimat SIGA Unjoni Ewropea - Malti - EMA (European Medicines Agency)

tecovirimat siga

siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - antivirali għal użu sistemiku - tecovirimat siga is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:- smallpox- monkeypox- cowpoxtecovirimat siga is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4. 4 u 5. tecovirimat siga should be used in accordance with official recommendations.

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

cibinqo

pfizer europe ma eeig  - abrocitinib - dermatite, atopika - preparazzjonijiet oħra dermatoloġiċi - cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.

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

dasatinib accord

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - aġenti antineoplastiċi - dasatinib accord is indicated for the treatment of adult patients with:• ph+ acute lymphoblastic leukaemia (all) with resistance or intolerance to prior therapy. dasatinib accord is indicated for the treatment of paediatric patients with:• newly diagnosed ph+ all in combination with chemotherapy.

Dasatinib Accordpharma Unjoni Ewropea - Malti - EMA (European Medicines Agency)

dasatinib accordpharma

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - aġenti antineoplastiċi - dasatinib accordpharma is indicated for the treatment of adult patients with: newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase.  chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib.  ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy. dasatinib accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.  newly diagnosed ph+ all in combination with chemotherapy.

Pirfenidone axunio (previously Pirfenidone AET) Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pirfenidone axunio (previously pirfenidone aet)

axunio pharma gmbh - pirfenidone - fibrożi pulmonari idjopatika - immunosoppressanti - pirfenidone aet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

Pirfenidone Viatris Unjoni Ewropea - Malti - EMA (European Medicines Agency)

pirfenidone viatris

viatris limited - pirfenidone - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - immunosoppressanti - pirfenidone viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

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

pyrukynd

agios netherlands b.v. - mitapivat sulfate - genetic diseases, inborn; anemia, hemolytic - other hematological agents - pyrukynd is indicated for the treatment of pyruvate kinase deficiency (pk deficiency) in adult patients (see section 4.

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

tibsovo

les laboratoires servier - ivosidenib - leukemia, myeloid, acute; cholangiocarcinoma - aġenti antineoplastiċi - tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) with an isocitrate dehydrogenase-1 (idh1) r132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an idh1 r132 mutation who were previously treated by at least one prior line of systemic therapy.

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

livtencity

takeda pharmaceuticals international ag ireland branch - maribavir - infezzjonijiet taċ-ċitomegalovirus - antivirali għal użu sistemiku - livtencity is indicated for the treatment of cytomegalovirus (cmv) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (hsct) or solid organ transplant (sot). għandha tingħata kunsiderazzjoni għall-gwida uffiċjali dwar l-użu adattat ta ' aġenti antivirali.

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

pemazyre

incyte biosciences distribution b.v. - pemigatinib - cholangiocarcinoma - aġenti antineoplastiċi - pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed  after at least one prior line of systemic therapy.