Europese Unie - Nederlands - EMA (European Medicines Agency)

novartis europharm limited - trametinib - melanoma - antineoplastische middelen - melanomatrametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 en 5. trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior braf inhibitor therapy (see section 5. adjuvant treatment of melanomatrametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a braf v600 mutation, following complete resection. niet-kleincellige longkanker (niet-kleincellig longcarcinoom)trametinib in combinatie met dabrafenib is geïndiceerd voor de behandeling van volwassen patiënten met gevorderd niet-kleincellig longkanker met een braf v600-mutatie.

Europese Unie - Nederlands - EMA (European Medicines Agency)

novartis europharm limited - dabrafenib mesilate - melanoma - antineoplastische middelen - melanomadabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 en 5. adjuvante behandeling van melanomadabrafenib in combinatie met trametinib is geïndiceerd voor de adjuvante behandeling van volwassen patiënten met een stadium iii melanoom met een braf v600-mutatie, na een complete resectie. non-small cell lung cancer (nsclc)dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a braf v600 mutation.

Europese Unie - Nederlands - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult 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. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the 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. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. 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 dfsp. 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. .

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

apotex europe bv archimedesweg 2 2333 cn leiden - erlotinibhydrochloride samenstelling overeenkomend met ; erlotinib - filmomhulde tablet - cellulose, microkristallijn (e 460) ; croscarmellose natrium (e 468) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; lactose 0-water ; magnesiumstearaat (e 470b) ; siliciumdioxide (e 551) ; titaandioxide (e 171) ; triethylcitraat (e 1505), - erlotinib

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

apotex europe bv archimedesweg 2 2333 cn leiden - erlotinibhydrochloride samenstelling overeenkomend met ; erlotinib - filmomhulde tablet - cellulose, microkristallijn (e 460) ; croscarmellose natrium (e 468) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; lactose 0-water ; magnesiumstearaat (e 470b) ; siliciumdioxide (e 551) ; titaandioxide (e 171) ; triethylcitraat (e 1505), - erlotinib

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

apotex europe bv archimedesweg 2 2333 cn leiden - erlotinibhydrochloride samenstelling overeenkomend met ; erlotinib - filmomhulde tablet - cellulose, microkristallijn (e 460) ; croscarmellose natrium (e 468) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; lactose 0-water ; magnesiumstearaat (e 470b) ; siliciumdioxide (e 551) ; titaandioxide (e 171) ; triethylcitraat (e 1505), - erlotinib

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

eg sa-nv - erlotinibhydrochloride 27,32 mg - eq. erlotinib 25 mg - filmomhulde tablet - 25 mg - erlotinibhydrochloride 27.32 mg - erlotinib

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

eg sa-nv - erlotinibhydrochloride 54,63 mg - eq. erlotinib 50 mg - filmomhulde tablet - 50 mg - erlotinibhydrochloride 54.63 mg - erlotinib

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

eg sa-nv - erlotinibhydrochloride 109,27 mg - eq. erlotinib 100 mg - filmomhulde tablet - 100 mg - erlotinibhydrochloride 109.27 mg - erlotinib

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

eg sa-nv - erlotinibhydrochloride 163,9 mg - eq. erlotinib 150 mg - filmomhulde tablet - 150 mg - erlotinibhydrochloride 163.9 mg - erlotinib