Europese Unie - Nederlands - 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.

Europese Unie - Nederlands - 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.

Europese Unie - Nederlands - 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.

Europese Unie - Nederlands - 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.

Europese Unie - Nederlands - 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.

Europese Unie - Nederlands - 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.

Europese Unie - Nederlands - 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.

Europese Unie - Nederlands - 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).

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

vetoquinol s.a. - carbetocine - oplossing voor injectie - carbetocine 0,07 mg/ml, - carbetocin - koeien; varkens

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

medcor pharmaceuticals b.v. - apraclonidinehydrochloride samenstelling overeenkomend met ; apraclonidine - oogdruppels, oplossing - natriumacetaat 3-water (e 262) ; natriumchloride ; natriumhydroxide (e 524) ; water, gezuiverd ; zoutzuur (e 507) - apraclonidine