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

roche nederland b.v. beneluxlaan 2a 3446 gr woerden - valganciclovirhydrochloride 496,3 samenstelling overeenkomend met ; valganciclovir 450 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460(i)) ; crospovidon (e 1202) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide rood (e 172) ; macrogol 400 ; polysorbaat 80 (e 433) ; povidon k 30 (e 1201) ; stearinezuur (e 570) ; titaandioxide (e 171), cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide rood (e 172) ; macrogol 400 ; polysorbaat 80 (e 433) ; povidon k 30 (e 1201) ; stearinezuur (e 570) ; titaandioxide (e 171), - valganciclovir

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

roche nederland b.v. beneluxlaan 2a 3446 gr woerden - valganciclovirhydrochloride 5,515 g/flacon samenstelling overeenkomend met ; valganciclovir 5 g/flacon - poeder voor drank - ananassmaakstof ; arabische gom (e 414) ; bananensmaakstof ; fumaarzuur (e 297) ; maltodextrine ; mannitol (d-) (e 421) ; natriumbenzoaat (e 211) ; perziksmaakstof ; povidon (e 1201) ; propyleenglycol (e 1520) ; saccharoide natrium x-water (e 954) ; tutti frutti flavour 11900-31 (ri), - valganciclovir

Europese Unie - Nederlands - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - antineoplastische middelen - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq als monotherapie is geïndiceerd voor de behandeling van volwassen patiënten met lokaal gevorderd of gemetastaseerd niet-kleincellig longcarcinoom na voorafgaande chemotherapie. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq als monotherapie is geïndiceerd voor de behandeling van volwassen patiënten met lokaal gevorderd of gemetastaseerd niet-kleincellig longcarcinoom na voorafgaande chemotherapie. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

Europese Unie - Nederlands - EMA (European Medicines Agency)

roche registration limited - emicizumab - hemophilia a - antihemorragica - hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia a (congenital factor viii deficiency):with factor viii inhibitorswithout factor viii inhibitors who have:severe disease (fviii < 1%)moderate disease (fviii ≥ 1% and ≤ 5%) with severe bleeding phenotype. hemlibra kan worden gebruikt in alle leeftijd groepen.

Europese Unie - Nederlands - EMA (European Medicines Agency)

roche registration gmbh - baloxavir marboxil - influenza, human - antivirale middelen voor systemisch gebruik - treatment of influenzaxofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. post exposure prophylaxis of influenzaxofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. xofluza should be used in accordance with official recommendations.

Europese Unie - Nederlands - EMA (European Medicines Agency)

roche registration gmbh  - risdiplam - spier-atrofie, spinale - andere geneesmiddelen voor aandoeningen van het musculo-skeletale systeem - evrysdi is indicated for the treatment of 5q spinal muscular atrophy (sma) in patients with a clinical diagnosis of sma type 1, type 2 or type 3 or with one to four smn2 copies.

Europese Unie - Nederlands - EMA (European Medicines Agency)

roche registration gmbh  - casirivimab, imdevimab - covid-19 virus infection - immuun-sera en immunoglobulinen, - ronapreve is indicated for:treatment of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19 (see section 4. prevention of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg (see section 4. the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. zie hoofdstuk 4. 4 en 5.

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

medcor pharmaceuticals b.v. - benserazidehydrochloride samenstelling overeenkomend met; benserazide; levodopa; - tablet - levodopa and decarboxylase inhibitor

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

medcor pharmaceuticals b.v. - benserazidehydrochloride samenstelling overeenkomend met; benserazide; levodopa; - capsule met gereguleerde afgifte, hard - levodopa and decarboxylase inhibitor

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

sandoz b.v. - ceftriaxon dinatrium 3,5-water samenstelling overeenkomend met ; ceftriaxon 0-water ; lidocainehydrochloride 1-water samenstelling overeenkomend met ; lidocaÏne - poeder en oplosmiddel voor oplossing voor injectie - natriumwaterstofcarbonaat (e 500 (ii)) ; stikstof (head space) (e 941) ; water voor injectie, - ceftriaxone, combinations