Uniunea Europeană - olandeză - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - neoplasmata van de borst - antineoplastische middelen - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Uniunea Europeană - olandeză - EMA (European Medicines Agency)

actavis group ptc ehf - topotecan - uterine cervical neoplasms; small cell lung carcinoma - antineoplastische middelen - topotecan monotherapy is indicated for the treatment of:- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy- patients with relapsed small cell lung cancer (sclc) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5. topotecan in combinatie met cisplatine is geïndiceerd voor patiënten met een carcinoom van de cervix recidief na radiotherapie voor patiënten met een stadium iv-ziekte. patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.

Țările de Jos - olandeză - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

lupin europe gmbh hanauer landstrasse 139-143 60314 frankfurt am main (duitsland) - emtricitabine ; tenofovirdisoproxilfumaraat samenstelling overeenkomend met ; tenofovirdisoproxil ; samenstelling overeenkomend met tenofovir - filmomhulde tablet - cellulose, microkristallijn (e 460) ; croscarmellose natrium (e 468) ; glyceroltriacetaat (e 1518) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; mannitol (d-) (e 421) ; siliciumdioxide (e 551) ; titaandioxide (e 171), - tenofovir disoproxil and emtricitabine

Țările de Jos - olandeză - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

lupin europe gmbh hanauer landstrasse 139-143 60314 frankfurt am main (duitsland) - fingolimodhydrochloride samenstelling overeenkomend met ; fingolimod - capsule, hard - aluminiummagnesiummetasilicaat, type 1a,b of c ; ammonia (e 527) ; gelatine (e 441) ; ijzeroxide geel (e 172) ; ijzeroxide zwart (e 172) ; kaliumhydroxide (e 525) ; natriumstearylfumaraat ; propyleenglycol (e 1520) ; schellak (e 904) ; titaandioxide (e 171) ; zwarte inkt

Țările de Jos - olandeză - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

hetero europe s.l. viladecans business park, edificio brasil, catalunya 83-85 08840 viladecans (spanje) - linezolid - oplossing voor infusie - citroenzuur 0-water (e 330) ; glucose 1-water ; natriumhydroxide (e 524) ; stikstof (head space) (e 941) ; trinatriumcitraat 2-water (e 331) ; water voor injectie ; zoutzuur (e 507), - linezolid

Țările de Jos - olandeză - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

apotex europe bv archimedesweg 2 2333 cn leiden - rosuvastatine calcium 0-water samenstelling overeenkomend met ; rosuvastatine - filmomhulde tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; macrogol 8000 ; magnesiumstearaat (e 470b) ; siliciumdioxide (e 551) ; titaandioxide (e 171), - rosuvastatin

Țările de Jos - olandeză - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

apotex europe bv archimedesweg 2 2333 cn leiden - rosuvastatine calcium 0-water samenstelling overeenkomend met ; rosuvastatine - filmomhulde tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; macrogol 8000 ; magnesiumstearaat (e 470b) ; siliciumdioxide (e 551) ; titaandioxide (e 171), - rosuvastatin

Țările de Jos - olandeză - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

apotex europe bv archimedesweg 2 2333 cn leiden - rosuvastatine calcium 0-water samenstelling overeenkomend met ; rosuvastatine - filmomhulde tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; macrogol 8000 ; magnesiumstearaat (e 470b) ; siliciumdioxide (e 551) ; titaandioxide (e 171), - rosuvastatin

Țările de Jos - olandeză - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

apotex europe bv archimedesweg 2 2333 cn leiden - rosuvastatine calcium 0-water samenstelling overeenkomend met ; rosuvastatine - filmomhulde tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; hyprolose (e 463) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; lactose 1-water ; macrogol 8000 ; magnesiumstearaat (e 470b) ; siliciumdioxide (e 551) ; titaandioxide (e 171), - rosuvastatin

Țările de Jos - olandeză - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

apotex europe bv - hydrochloorthiazide ; telmisartan - tablet - calciumwaterstoffosfaat 0-water (e 341) ; cellulose, microkristallijn (e 460) ; croscarmellose natrium (e 468) ; ijzeroxide rood (e 172) ; isomalt (e 953) ; kaliumhydroxide (e 525) ; magnesiumstearaat (e 470b) ; mannitol (d-) (e 421) ; meglumine ; povidon k 30 (e 1201), - telmisartan and diuretics