Unione Europea - olandese - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride hydrate - multiple myeloma; lymphoma, follicular; myelodysplastic syndromes - immunosuppressiva - multiple myelomalenalidomide krka d. as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) is geïndiceerd voor de behandeling van volwassen patiënten met eerder behandelde multipel myeloom die niet in aanmerking komen voor transplantatie. lenalidomide krka d. in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. follicular lymphomalenalidomide krka d. in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Unione Europea - olandese - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastische middelen - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patiënten met een laag of zeer laag risico op herhaling, moet niet ontvangen adjuvante behandeling. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. behalve in nieuw gediagnosticeerde cml in de chronische fase, er zijn geen gecontroleerde studies tonen een klinisch voordeel of een toegenomen overleving voor deze ziekten.

Unione Europea - olandese - EMA (European Medicines Agency)

nova laboratories ireland limited - spironolacton - edema; heart failure; liver cirrhosis; ascites; nephrotic syndrome; hyperaldosteronism; essential hypertension - antihypertensives and diuretics in combination - in the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5. 1 en 5.

Unione Europea - olandese - EMA (European Medicines Agency)

plusultra pharma gmbh - sirolimus - angiofibroma; tuberous sclerosis - hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.

Paesi Bassi - olandese - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

sandoz b.v. veluwezoom 22 1327 ah almere - omeprazol natrium, 1-water samenstelling overeenkomend met ; omeprazol - poeder voor oplossing voor injectie - dinatriumedetaat 2-water ; natriumhydroxide (e 524), - omeprazole

Paesi Bassi - olandese - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

sandoz b.v. veluwezoom 22 1327 ah almere - ceftriaxon dinatrium 3,5-water samenstelling overeenkomend met ; ; ceftriaxon 0-water 500 mg/flacon - poeder voor oplossing voor injectie - geen hulpstoffen, - ceftriaxone

Paesi Bassi - olandese - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

sandoz b.v. veluwezoom 22 1327 ah almere - ceftriaxon dinatrium 3,5-water samenstelling overeenkomend met ; ; ceftriaxon 0-water 1 g/flacon - poeder voor oplossing voor injectie of infusie - geen hulpstoffen, - ceftriaxone

Paesi Bassi - olandese - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

sandoz b.v. veluwezoom 22 1327 ah almere - ceftriaxon dinatrium 3,5-water samenstelling overeenkomend met ; ; ceftriaxon 0-water 2 g/flacon - poeder voor oplossing voor injectie of infusie - geen hulpstoffen, - ceftriaxone

Paesi Bassi - olandese - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

sandoz b.v. veluwezoom 22 1327 ah almere - omeprazol natrium, 1-water 42,56 mg/flacon samenstelling overeenkomend met ; omeprazol 40 mg/flacon - poeder en oplosmiddel voor oplossing voor injectie - dinatriumedetaat 2-water ; natriumhydroxide (e 524), - omeprazole

Paesi Bassi - olandese - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

rubimed b.v. avenue ceramique 223 6221 kx maastricht - cerebrum suis d21 ; plumbum metallicum d21 ; staphisagria c50 ; viscum album d21 - druppels voor oraal gebruik, oplossing - ethanol 96 % ; water, purified, , , , , , , , , , , , , , , , , , , , , , , , , , , , - datum verstrekking handelsvergunning:30 juni 2011