Europese Unie - Nederlands - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belantamab mafodotin - multiple myeloma - antineoplastische middelen - blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Europese Unie - Nederlands - EMA (European Medicines Agency)

mylan ire healthcare limited - pretomanid - tuberculose, multiresistente - antimycobacteriële - dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (xdr), or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). aandacht moet worden gegeven aan de officiële richtlijnen betreffende het juiste gebruik van antibacteriële agentia.

Europese Unie - Nederlands - EMA (European Medicines Agency)

seagen b.v. - tucatinib - breast neoplasms; neoplasm metastasis - antineoplastische middelen - tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with her2‑positive locally advanced or metastatic breast cancer who have received at least 2 prior anti‑her2 treatment regimens.

Europese Unie - Nederlands - EMA (European Medicines Agency)

viiv healthcare b.v. - fostemsavir trometamol - hiv-infecties - antivirale middelen voor systemisch gebruik - rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant hiv-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

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

amlodipinebesilaat 13,87 mg/stuk samenstelling overeenkomend met ; amlodipine 10 mg/stuk ; indapamide 0-water 2,5 mg/stuk ; perindopril arginine 10 mg/stuk samenstelling overeenkomend met ; perindopril 6,79 mg/stuk - filmomhulde tablet - calciumcarbonaat (e 170) ; cellulose, microkristallijn (e 460) ; croscarmellose natrium (e 468) ; glycerol (e 422) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; macrogol 6000 ; magnesiumstearaat (e 470b) ; maÏszetmeel, gepregelatineerd ; siliciumdioxide (e 551) ; titaandioxide (e 171) ; zetmeel, gepregelatineerd

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

amlodipinebesilaat 6,935 mg/stuk samenstelling overeenkomend met ; amlodipine 5 mg/stuk ; indapamide 0-water 2,5 mg/stuk ; perindopril arginine 10 mg/stuk samenstelling overeenkomend met ; perindopril 6,79 mg/stuk - filmomhulde tablet - calciumcarbonaat (e 170) ; cellulose, microkristallijn (e 460) ; croscarmellose natrium (e 468) ; glycerol (e 422) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; macrogol 6000 ; magnesiumstearaat (e 470b) ; maÏszetmeel, gepregelatineerd ; siliciumdioxide (e 551) ; titaandioxide (e 171) ; zetmeel, gepregelatineerd

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

amlodipinebesilaat 13,9 mg/stuk samenstelling overeenkomend met ; amlodipine 10 mg/stuk ; indapamide 0-water 1,25 mg/stuk ; perindopril arginine 5 mg/stuk samenstelling overeenkomend met ; perindopril 3,395 mg/stuk - filmomhulde tablet - calciumcarbonaat (e 170) ; cellulose, microkristallijn (e 460) ; croscarmellose natrium (e 468) ; glycerol (e 422) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; macrogol 6000 ; magnesiumstearaat (e 470b) ; maÏszetmeel, gepregelatineerd ; siliciumdioxide (e 551) ; titaandioxide (e 171) ; zetmeel, gepregelatineerd

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

amlodipinebesilaat 6,935 mg/stuk samenstelling overeenkomend met ; amlodipine 5 mg/stuk ; indapamide 0-water 1,25 mg/stuk ; perindopril arginine 5 mg/stuk samenstelling overeenkomend met ; perindopril 3,395 mg/stuk - filmomhulde tablet - calciumcarbonaat (e 170) ; cellulose, microkristallijn (e 460) ; croscarmellose natrium (e 468) ; glycerol (e 422) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; macrogol 6000 ; magnesiumstearaat (e 470b) ; maÏszetmeel, gepregelatineerd ; siliciumdioxide (e 551) ; titaandioxide (e 171) ; zetmeel, gepregelatineerd

Europese Unie - Nederlands - EMA (European Medicines Agency)

janssen-cilag international n.v. - teclistamab - multiple myeloma - antineoplastische middelen - tecvayli is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Europese Unie - Nederlands - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - carcinoma, hepatocellular - antineoplastische middelen - imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc). imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.