Eiropas Savienība - holandiešu - EMA (European Medicines Agency)

biocryst ireland limited - berotralstat dihydrochloride - angioedemas, erfelijk - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

Eiropas Savienība - holandiešu - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastische middelen - 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.

Eiropas Savienība - holandiešu - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastische middelen - 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.

Eiropas Savienība - holandiešu - EMA (European Medicines Agency)

accord healthcare s.l.u. - leuprorelin mesilate - prostaatnoplasma - endocriene therapie - camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.

Eiropas Savienība - holandiešu - EMA (European Medicines Agency)

ptc therapeutics international limited - eladocagene exuparvovec - aminozuur metabolisme, aangeboren fouten - 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.

Eiropas Savienība - holandiešu - EMA (European Medicines Agency)

argenx - efgartigimod alfa - myasthenia gravis - immunosuppressiva - vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti acetylcholine receptor (achr) antibody positive.

Beļģija - holandiešu - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - rivaroxaban 15 mg (rode tablet (15 mg)); rivaroxaban 20 mg (bruinrode tablet (20 mg)) - filmomhulde tablet - rivaroxaban

Beļģija - holandiešu - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - rivaroxaban 2,5 mg - filmomhulde tablet - rivaroxaban

Eiropas Savienība - holandiešu - EMA (European Medicines Agency)

lipomed gmbh - thalidomide - multiple myeloma - immunosuppressiva - thalidomide lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy. thalidomide lipomed is prescribed and dispensed in accordance with the thalidomide lipomed pregnancy prevention programme (see section 4.

Eiropas Savienība - holandiešu - EMA (European Medicines Agency)

accord healthcare s.l.u. - tolvaptan - onjuist adh-syndroom - diuretica, - tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (siadh).