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

teriflunomide 14 mg/stuk - filmomhulde tablet - allurarood ac aluminium lak (e 129) ; briljantblauw fcf aluminiumlak (e133) ; cellulose, microkristallijn (e 460(i)) ; glycerol (e 422) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; natriumzetmeelglycolaat ; siliciumdioxide (e 551) ; talk (e 553 b) ; titaandioxide (e 171), allurarood ac aluminium lak (e 129) ; briljantblauw fcf aluminiumlak (e133) ; cellulose, microkristallijn (e 460) ; glycerol (e 422) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; natriumzetmeelglycolaat ; siliciumdioxide (e 551) ; talk (e 553 b) ; titaandioxide (e 171)

Europese Unie - Nederlands - EMA (European Medicines Agency)

akebia europe limited - vadadustat - renal insufficiency, chronic; anemia - antianemische preparaten - vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adults on chronic maintenance dialysis.

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

krka d.d. novo mesto d.d. - teriflunomide 14 mg - filmomhulde tablet - teriflunomide

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - teriflunomide 14 mg - filmomhulde tablet - teriflunomide

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

teriflunomide 14 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; glyceroltriacetaat (e 1518) ; hyprolose (e 463) ; hypromellose (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; natriumzetmeelglycolaat ; siliciumdioxide (e 551) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; glyceroltriacetaat (e 1518) ; hyprolose (e 463) ; hypromellose (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; natriumzetmeelglycolaat ; siliciumdioxide (e 551) ; titaandioxide (e 171)

Europese Unie - Nederlands - EMA (European Medicines Agency)

accord healthcare s.l.u. - doxorubicin hydrochloride, liposomal - ovarian neoplasms; sarcoma, kaposi; multiple myeloma - doxorubicin - zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:• breast cancer that has spread to other parts of the body in patients at risk of heart problems. zolsketil pegylated liposomal is used on its own for this disease;• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);• kaposi’s sarcoma in patients with aids who have a very damaged immune system. kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. this means that it is similar to a ‘reference medicine’ containing the same active substance called adriamycin. however, in zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for adriamycin.

Europese Unie - Nederlands - EMA (European Medicines Agency)

yes pharmaceutical development services gmbh - doxorubicine hydrochloride - breast neoplasms; ovarian neoplasms; multiple myeloma; sarcoma, kaposi - antineoplastische middelen - celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of aids-related kaposi’s sarcoma (ks) in patients with low cd4 counts (< 200 cd4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).

Europese Unie - Nederlands - EMA (European Medicines Agency)

amryt pharmaceuticals dac - lomitapide - hypercholesterolemie - lipidemodificerende middelen - lojuxta wordt aangegeven als een aanvulling op een dieet van low‑fat en andere lipid‑lowering geneesmiddelen met of zonder low-density-lipoproteïne (ldl) aferese bij volwassen patiënten met homozygoot familiale hypercholesterolemie (hofh). genetische bevestiging van hofh moet worden verkregen indien mogelijk. andere vormen van primaire hyperlipoproteinaemia en secundaire oorzaken van hypercholesterolemie (e. nefrotisch syndroom, hypothyreoïdie) dient te worden uitgesloten.

Europese Unie - Nederlands - EMA (European Medicines Agency)

novartis europharm limited - eltrombopag - purpura, thrombocytopenic, idiopathic - other systemic hemostatics, antihemorrhagics - revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (itp) who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 en 5. revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (itp) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 en 5. revolade is indicated in adult patients with chronic hepatitis c virus (hcv) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. revolade is indicated in adult patients with acquired severe aplastic anaemia (saa) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.

Europese Unie - Nederlands - EMA (European Medicines Agency)

roche registration gmbh - vemurafenib - melanoma - antineoplastische middelen - vemurafenib is geïndiceerd in monotherapie voor de behandeling van volwassen patiënten met braf-v600-mutatie-positief niet-reseceerbaar of gemetastaseerd melanoom.