Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - karsinom, ikke-småcellet lunge - antineoplastiske midler - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastiske midler - dasatinib accord is indicated for the treatment of adult patients with:• ph+ acute lymphoblastic leukaemia (all) with resistance or intolerance to prior therapy. dasatinib accord is indicated for the treatment of paediatric patients with:• newly diagnosed ph+ all in combination with chemotherapy.

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastiske midler - dasatinib accordpharma is indicated for the treatment of adult patients with: newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase.  chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib.  ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy. dasatinib accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.  newly diagnosed ph+ all in combination with chemotherapy.

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

astellas pharma europe b.v. - enfortumab vedotin - carcinoma, transitional cell; urologic neoplasms - antineoplastiske midler - padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

merck europe b.v. - tepotinib hydrochloride monohydrate - karsinom, ikke-småcellet lunge - antineoplastiske midler - tepmetko as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

novartis europharm limited  - capmatinib dihydrochloride monohydrate - karsinom, ikke-småcellet lunge - antineoplastiske midler - tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (nsclc) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (metex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

lipomed gmbh - thalidomid - multippelt myelom - immunsuppressive - thalidomide lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy. thalidomide lipomed is prescribed and dispensed in accordance with the thalidomide lipomed pregnancy prevention programme (see section 4.

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

novartis europharm limited  - lutetium (177lu) vipivotide tetraxetan - prostatic neoplasmer, kastrering-resistant - terapeutisk radiofarmaka - pluvicto in combination with androgen deprivation therapy (adt) with or without androgen receptor (ar) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (psma)-positive metastatic castration-resistant prostate cancer (mcrpc) who have been treated with ar pathway inhibition and taxane based chemotherapy.

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - immunostimulants, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4. paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.

Uniunea Europeană - norvegiană - EMA (European Medicines Agency)

baxter holding b.v. - pemetrexed disodium heptahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastiske midler - malignant pleural mesotheliomapemetrexed baxter in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancerpemetrexed baxter in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5. pemetrexed baxter is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5. pemetrexed baxter is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.