Europese Unie - Nederlands - EMA (European Medicines Agency)

bayer ag - sorafenib - carcinoma, hepatocellular; carcinoma, renal cell - antineoplastische middelen - hepatocellulair carcinomanexavar is geïndiceerd voor de behandeling van hepatocellulair carcinoom. nier cel carcinomanexavar is geïndiceerd voor de behandeling van patiënten met gevorderd niercelcarcinoom die niet hebben voordat de behandeling met interferon-alfa of interleukine-2 therapie of worden beschouwd als ongeschikt voor een dergelijke therapie. gedifferentieerd schildklier carcinomanexavar is geïndiceerd voor de behandeling van patiënten met een progressieve, lokaal gevorderde of gemetastaseerde gedifferentieerde (papillair/follicular/hürthle cel) schildklier carcinoom, vuurvaste aan radioactief jodium.

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

neutec inhaler ireland limited 22 northumberland road dublin 4 (ierland) - fluticasonpropionaat 100 µg/dosis ; salmeterolxinafoaat 72,6 µg/dosis samenstelling overeenkomend met ; salmeterol 50 µg/dosis - inhalatiepoeder, voorverdeeld - lactose 1-water

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

neutec inhaler ireland limited 22 northumberland road dublin 4 (ierland) - fluticasonpropionaat 250 µg/dosis ; salmeterolxinafoaat 73 µg/dosis samenstelling overeenkomend met ; salmeterol 50 µg/dosis - inhalatiepoeder, voorverdeeld - lactose 1-water

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

neutec inhaler ireland limited 22 northumberland road dublin 4 (ierland) - fluticasonpropionaat 500 µg/dosis ; salmeterolxinafoaat 73 µg/dosis samenstelling overeenkomend met ; salmeterol 50 µg/dosis - inhalatiepoeder, voorverdeeld - lactose 1-water

Europese Unie - Nederlands - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antineoplastische middelen - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. patiënten met egfr-of alk-positieve tumor mutaties moet ook ontvangen gerichte therapie voor het ontvangen van keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Europese Unie - Nederlands - EMA (European Medicines Agency)

novartis europharm limited  - gozetotide - radionuclide-beeldvorming - diagnostische radiofarmaceutica - dit geneesmiddel is uitsluitend voor diagnostisch gebruik. locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high risk pca prior to primary curative therapy,suspected pca recurrence in patients with increasing levels of serum prostate specific antigen (psa) after primary curative therapy,identification of patients with psma positive progressive metastatic castration resistant prostate cancer (mcrpc) for whom psma targeted therapy is indicated (see section 4.

Europese Unie - Nederlands - EMA (European Medicines Agency)

curium pet france - piflufolastat (18f) - prostaatnoplasma - diagnostische radiofarmaceutica - dit geneesmiddel is uitsluitend voor diagnostisch gebruik. pylclari is indicated for the detection of prostate-specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high-risk pca prior to initial curative therapy,to localize recurrence of pca in patients with a suspected recurrence based on increasing serum prostate-specific antigen (psa) levels after primary treatment with curative intent. pylclari is indicated for use with positron emission tomography (pet).

Europese Unie - Nederlands - EMA (European Medicines Agency)

eli lilly nederland b.v. - florbetapir (18f) - radionuclide-beeldvorming - diagnostische radiofarmaceutica - dit geneesmiddel is uitsluitend voor diagnostisch gebruik. amyvid is een radiofarmaceuticum wordt aangegeven voor positron emissie tomografie (pet) beeldvorming van β-amyloïde neuritic plaque dichtheid in de hersenen van volwassen patiënten met cognitieve stoornissen die worden geëvalueerd voor de ziekte van alzheimer (ad) en andere oorzaken van cognitieve stoornissen. amyvid moet worden gebruikt in combinatie met een klinische evaluatie. een negatieve scan geeft dun of geen plaques, die niet in overeenstemming is met een diagnose van ad.

Europese Unie - Nederlands - EMA (European Medicines Agency)

cis bio international  - besilesomab - osteomyelitis; radionuclide imaging - diagnostische radiofarmaceutica - dit geneesmiddel is uitsluitend voor diagnostisch gebruik en de goedgekeurde indicatie is scintigrafische beeldvorming, in combinatie met andere geschikte beeldvormingstechnieken, voor het bepalen van de locatie van ontsteking / infectie in perifere botten bij volwassenen met verdenking op osteomyelitis. scintimun mag niet worden gebruikt voor de diagnose van een diabetische voetinfectie.

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

novartis pharma b.v. haaksbergweg 16 1101 bx amsterdam - mycofenolaat natrium 192,4 mg/stuk samenstelling overeenkomend met ; mycofenolzuur 180 mg/stuk - maagsapresistente tablet - crospovidon (e 1202) ; hypromelloseftalaat ; ijzeroxide geel (e 172) ; indigokarmijn (e 132) ; lactose 0-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) ; titaandioxide (e 171) - mycophenolic acid