Published on 8 June 2021 Oncology and Hematology 131I-omburtamab 177Lu-PSMA-617 IND Abemaciclib IND Abiraterone Geïndiceerd met prednison of prednisolon voor: - de behandeling van nieuw gediagnosticeerde hoog-risico gemetastaseerde hormoongevoelige prostaatkanker (mHSPC) bij volwassen mannen, in combinatie met androgeendeprivatietherapie (ADT); - de behandeling van gemetastaseerde castratieresistente prostaatkanker (mCRPC) bij volwassen mannen die asymptomatisch of licht symptomatisch zijn na falen van androgeendeprivatietherapie en voor wie behandeling met chemotherapie nog niet klinisch geïndiceerd is ; - de behandeling van mCRPC bij volwassen mannen bij wie de ziekte progressief was tijdens of na een chemotherapieschema op basis van docetaxel. G Geïndiceerd met prednison of prednisolon voor: - de behandeling van nieuw gediagnosticeerde hoog-risico gemetastaseerde hormoongevoelige prostaatkanker (mHSPC) bij volwassen mannen, in combinatie met androgeendeprivatietherapie (ADT); - de behandeling van gemetastaseerde castratieresistente prostaatkanker (mCRPC) bij volwassen mannen die asymptomatisch of licht symptomatisch zijn na falen van androgeendeprivatietherapie en voor wie behandeling met chemotherapie nog niet klinisch geïndiceerd is ; - de behandeling van mCRPC bij volwassen mannen bij wie de ziekte progressief was tijdens of na een chemotherapieschema op basis van docetaxel. G Geïndiceerd met prednison of prednisolon voor: - de behandeling van nieuw gediagnosticeerde hoog-risico gemetastaseerde hormoongevoelige prostaatkanker (mHSPC) bij volwassen mannen, in combinatie met androgeendeprivatietherapie (ADT); - de behandeling van gemetastaseerde castratieresistente prostaatkanker (mCRPC) bij volwassen mannen die asymptomatisch of licht symptomatisch zijn na falen van androgeendeprivatietherapie en voor wie behandeling met chemotherapie nog niet klinisch geïndiceerd is ; - de behandeling van mCRPC bij volwassen mannen bij wie de ziekte progressief was tijdens of na een chemotherapieschema op basis van docetaxel. G Abiraterone / apalutamide Acalabrutinib Calquence as monotherapy is indicated for the treatment of adult patients with relapsed/refractory CLL (chronic lymphocytic leukemia). Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). Alpelisib Amivantamab Apalutamide IND Arseentrioxide Geïndiceerd voor het induceren van remissie en consolidatie bij volwassen patiënten met: 1) nieuw gediagnosticeerde acute promyelocytaire leukemie (APL) met laag tot middelmatig risico (aantal witte bloedcellen ≤ 10 x 103/μl) in combinatie met all-trans-retinoïnezuur (ATRA), 2) recidiverende/refractaire acute promyelocytaire leukemie (APL) (tijdens een eerdere behandeling moet een retinoïde stof zijn toegediend en chemotherapie hebben plaatsgehad), gekenmerkt door de aanwezigheid van de translocatie t(15;17) en/of de aanwezigheid van het gen promyeolocitaire-leukemie-/retinoïnezuurreceptor-alfa (PML/RAR-alfa). G Geïndiceerd voor het induceren van remissie en consolidatie bij volwassen patiënten met: 1) nieuw gediagnosticeerde acute promyelocytaire leukemie (APL) met laag tot middelmatig risico (aantal witte bloedcellen ≤ 10 x 103/μl) in combinatie met all-trans-retinoïnezuur (ATRA), 2) recidiverende/refractaire acute promyelocytaire leukemie (APL) (tijdens een eerdere behandeling moet een retinoïde stof zijn toegediend en chemotherapie hebben plaatsgehad), gekenmerkt door de aanwezigheid van de translocatie t(15;17) en/of de aanwezigheid van het gen promyeolocitaire-leukemie-/retinoïnezuurreceptor-alfa (PML/RAR-alfa). G Asciminib Atezolizumab Extension of indication to include Tecentriq in combination with nab-paclitaxel and anthracycline-based chemotherapy for the neoadjuvant treatment of adult patients with locally advanced or early Triple Negative Breast Cancer (TNBC). IND Extension of indication to include, in combination with bevacizumab, the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. IND Extension of indication to include, in combination with platinum-based chemotherapy, first-line treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) for Tecentriq. IND mM 1L BRAF+ in combinatie met cobimetinib en vemurafenib. IND Adjuvant treatment after surgical resection of high-risk muscle-invasive bladder cancer (MIBC). IND 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. IND Autologous glioma tumor cell lysates Avapritinib Avelumab Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). IND First-line Treatment of Recurrent or Stage IV PD-L1+ Non-small Cell Lung Cancer. IND Bavencio is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. IND Axicabtagene ciloleucel Recidiverend of refractair na 1 of meer lijnen van therapie DLBCL, transplant-eligible. IND Recidiverend of refractair na 2 of meer lijnen van therapie iNHL (alleen FL en MZL). IND Azacitidine Balixafortide Belantamab mafodotin 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. Multiple Myeloma 3L IND Blinatumomab Blincyto is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. IND Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor ALL as part of the consolidation therapy. IND Brigatinib IND Cabazitaxel G Cabozantinib IND Capmatinib Carfilzomib IND Cemiplimab Monotherapy treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. Libtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI). IND Libtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ≥ 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC. IND Cemiplimab is being investigated in recurrent, persistent, and/or metastatic cervical cancer (2L mono) with squamous cell histology, for which there is not a curative-intent option (surgery or radiation therapy with or without chemotherapy). Tumor progression or recurrence after treatment with platinum therapy (must have been used to treat metastatic, persistent, or recurrent cervical cancer). IND Cemiplimab wordt onderzocht als eerstelijns behandeling in combinatie met chemotherapie voor volwassen patiënten met lokaal gevorderd of gemetastaseerde plaveiselcel en niet-plaveiselcel NSCLC (stadium IIIB/C-IV) onafhankelijk van PD-L1 expressie. IND Copanlisib DCVAC Daratumumab Extension of indication to extend the existing therapeutic indication for daratumumab in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). IND Extension of indication to extend the existing therapeutic indication for daratumumab in combination with lenalidomide and dexamethasone (Rd) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). IND Darzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis. IND In combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy. IND Subcutaneous formulation indicates for Relapsed or Refractory Multiple Myeloma. IND Multipel myeloom frontline behandeling in cpmbinatie met VRd voor patiënten die niet in aanmerking komen voor een ASCT. IND Multipel myeloom frontline onderhoudsbehandeling na DVTd, voor patiënten die in aanmerking komen voor een ASCT. IND Smouldering multipel myeloom. IND Darleukin fibromun Darolutamide Nubeqa is indicated for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. Adult men with metastatic hormone senstive prostate cancer (mHSPC) in combination with docetaxel en ADT. IND Dasatinib Geïndiceerd voor de behandeling van volwassen patiënten met: nieuw gediagnosticeerde Philadelphiachromosoom-positieve (Ph+) chronische myeloïde leukemie (CML) in de chronische fase. CML in de chronische, acceleratie- of blastaire fase, die resistent of intolerant zijn voor eerder toegediende geneesmiddelen inclusief imatinib. Ph+ acute lymfoblastaire leukemie (ALL) en lymfoïde blasten CML die resistent of intolerant zijn voor eerder toegediende geneesmiddelen. Ook geïndiceerd voor de behandeling van pediatrische patiënten met: nieuw gediagnosticeerde Ph+ CML in de chronische fase (Ph+ CML-CP) of met Ph+ CML-CP die resistent of intolerant zijn voor eerder toegediende geneesmiddelen waaronder imatinib. Nieuw gediagnosticeerde Ph+ ALL in combinatie met chemotherapie. G Geïndiceerd voor de behandeling van volwassen patiënten met: nieuw gediagnosticeerde Philadelphiachromosoom-positieve (Ph+) chronische myeloïde leukemie (CML) in de chronische fase. CML in de chronische, acceleratie- of blastaire fase, die resistent of intolerant zijn voor eerder toegediende geneesmiddelen inclusief imatinib. Ph+ acute lymfoblastaire leukemie (ALL) en lymfoïde blasten CML die resistent of intolerant zijn voor eerder toegediende geneesmiddelen. Ook geïndiceerd voor de behandeling van pediatrische patiënten met: nieuw gediagnosticeerde Ph+ CML in de chronische fase (Ph+ CML-CP) of met Ph+ CML-CP die resistent of intolerant zijn voor eerder toegediende geneesmiddelen waaronder imatinib. Nieuw gediagnosticeerde Ph+ ALL in combinatie met chemotherapie. G Dostarlimab Durvalumab Non-small cell lung cancer (NSCLC) stage IV, in combination with tremelimumab and chemo,1L. Squamous cell carcinoma of the head and neck, 1L PDL 1 in combination with tremelimumab. IND Neo-adjuvant durvalumab met chemotherapie en adjuvant durvalumab voor behandeling in patiënten met spier invasieve blaaskanker. IND Non-small cell lung cancer (NSCLC) stage IV, in combination with chemo, 1L. IND Squamous cell carcinoma of the head and neck, 1L PDL 1. IND Imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). IND 1L advanced NSCLC IND Completely resected NSCLC IND Lokaal gevorderd, niet-resectabel NSCLC (stadium III) IND Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer. IND Durvalumab (+/- bevacizumab) in combinatie met TACE in patiënten met locoregionale HCC. IND In combination with tremelimumab in patients with HCC not eligible for locoregional therapy (1L). IND Duvelisib Efbemalenograstim alfa Eflornithine / sulindac Enfortumab vedotin Ensartinib Entrectinib Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older, with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor or who have no satisfactory treatment options. Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors. Enzalutamide IND Eprenetapopt Erdafitinib Eryaspase (Asparaginase) Fedratinib Gilteritinib Glasdegib Glucarpidase Guadecitabine Hypericin Ibrutinib Extension of indication to include treatment of adult patients with Waldenström's macroglobulinaemia (WM) in combination with rituximab. IND Extension of indication to the existing chronic lymphocytic leukaemia (CLL) indication to include combination use with obinutuzumab for the treatment of adult patients with previously untreated CLL. IND Follicular lymphoma (FL), relapsed / refractory. IND Marginal zone lymphoma (MZL), relapsed / refractory. IND Mantle cell lymphoma (MCL), 1L. IND Extension of indication in chronic lymphocytic leukaemia (CLL) to add combination with rituximab as follows; Ibrutinib in combination with rituximab or obinutuzumab for the treatment of adult patients with previously untreated CLL (Young and Fit). IND Idasanutlin Idecabtagene vicleucel Imetelstat Inolimomab Iomab-B Isatuximab Sarclisa is indicated in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. IND In Combination With Bortezomib, Lenalidomide and Dexamethasone (Isa VRd) in Patients With Newly Diagnosed Multiple Myeloma (NDMM) Not Eligible for Transplant. IND Itacitinib Ivosidenib IND JNJ-4528 Larotrectinib Lenalidomide IND Lenvatinib Extension of indication to include lenvatinib in combination with pembrolizumab for the treatment of adult patients with advanced endometrial carcinoma (EC) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation; as a consequence. IND KISPLYX is indicated for the treatment of adults with advanced renal cell carcinoma (RCC) in combination with pembrolizumab, as first-line treatment. IND Leukocyte interleukin Lifileucel Maliganant melanoma, advanced melanoma. Treatment of Patients With Cervical Carcinoma (2L) Lipegfilgrastim IND Lisocabtagene maraleucel Lorlatinib IND Lurbinectedin MB-CART2019.1 Margetuximab Masitinib Motixafortide Moxetumomab pasudotox NY-ESO-1 autologous engineered TCR-T cells Narsoplimab Neratinib IND Niraparib IND Nivolumab Opdivo in combination with ipilimumab is indicated for the first line treatment of adult patients with unresectable malignant pleural mesothelioma. IND Opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. IND Opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. IND Extension of indication for Opdivo to include adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) who are at high risk of recurrence after undergoing radical resection of MIUC. IND Extension of indication in combination with ipilimumab to include treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC) for combination treatment with Opdivo and Yervoy; IND Extension of indication to include adjuvant treatment of adult patients with resected oesophageal, or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy for OPDIVO. IND Extension of indication to use Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy, in first-line treatment of adult patients with advanced or metastatic gastric, gastro-oesophageal junction (GEJ) or oesophageal adenocarcinoma. IND Olaparib Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. IND Monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. (only BRCA mutations included in the indication). IND Lynparza in combination with bevacizumab is indicated for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability. IND Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA). IND Treatment in combination with abiraterone acetate in patients with metastatic Castration-resistant Prostate Cancer (mCRPC) who have not received prior chemotherapy or new hormonal agents (NHAs) for metastatic castration-resistant prostate cancer (mCRPC) (first-line setting). IND Omidubicel Oportuzumab monatox Osimertinib IND Paclitaxel Pembrolizumab Extension of indication for Keytruda to include in combination with chemotherapy, 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. IND Keytruda as monotherapy is indicated for the first‑line treatment of metastatic microsatellite instability‑high (MSI‑H) or mismatch repair deficient (dMMR) colorectal cancer in adults. IND Triple Negative Breast Cancer - Neoadjuvant and adjuvant. IND Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy. IND Advanced Hepatocellular Carcinoma in combination with lenvatinib (1L). IND Extension of indication for Keytruda to include in combination with lenvatinib first line treatment of adults with advanced renal cell carcinoma (RCC). IND Extension of indication to include pembrolizumab in combination with lenvatinib for the treatment of advanced endometrial carcinoma in adults who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation. IND 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) following at least two prior therapies when ASCT is not a treatment option. IND Keytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of patients with 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. IND Locally Advanced Head and Neck Squamous Cell Carcinoma With Chemoradiation. IND Women With Persistent, Recurrent, or Metastatic Cervical Cancer (1L). IND Pemigatinib Pertuzumab / trastuzumab Pevonedistat Polatuzumab vedotin Pomalidomide IND Pralsetinib Relatlimab Relugolix Remestemcel-L Retifanlimab Rimiducid Ripretinib Rivoceranib Rivogenlecleucel Ruxolitinib IND Sacituzumab govitecan Sapacitabine Selinexor Nexpovio is indicated in combination with dexamethasone 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 two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. Extension of indication for Nexpovio in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. IND Patients diagnosed with advanced unresectable dedifferentiated liposarcoma. IND Selpercatinib Advanced RET fusion-positive non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. Patients With RET-Mutant Medullary Thyroid Cancer. Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Selumetinib Seviprotimut-L Sodium thiosulfate Sotorasib Surufatinib Tabelecleucel Tafasitamab Tagraxofusp Tavokinogene telseplasmid Tedopi Tegafur / gimeracil / oteracil IND Tepotinib Tesetaxel Thiotepa G Tivozanib IND Trastuzumab deruxtecan Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti HER2 based regimens. Patients with HER2 low, unresectable, and/or metastatic breast cancer previously treated with 1-2 prior lines of chemotherapy in the metastatic setting and has progressed on, and would no longer benefit from, endocrine therapy. IND Treatment of adult patients with Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane 2L. IND Treatment of ER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens. IND Trastuzumab duocarmazine Trastuzumab emtansine IND Tremelimumab Trilaciclib Tucatinib Ublituximab Umbralisib Veliparib Venetoclax Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy. IND Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL). IND Vocimagene amiretrorepvec Zanubrutinib Mantle-cell lymphoma (1L) + Rituximab. Patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or as first-line treatment for patients unsuitable for chemo-immunotherapy. autologous anti-CD19-transduced CD3+ cells Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Behandeling van volwassen patiënten recidiverend of refractair na 2 of meer lijnen van therapie met refractaire B-cel acute lymfoblastaire leukemie (ALL). IND ibrutinib IND Metabolism and Endocrinology Arimoclomol Autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene Autologous human chondrocytes in vitro expanded Avalglucosidase alfa Betaine G Bexagliflozine Burosumab IND Cenicriviroc Cipaglucosidase alfa / Miglustat Dapagliflozine Treatment of patients with chronic kidney disease. IND Extension of indication for Forxiga / Edistride to include treatment of children aged 10 years and adolescents with T2DM based on the results from studies IND Dasiglucagon Diazoxide choline (controlled-release tablet) Drospirenon / estetrol, monohydraat Elamipretide Elivaldogene autotemcel Exenatide Fexapotide Finerenone Givosiran Glucagon Hydrocortison Insulin aspart BS Insulin lispro (ultra rapid formulation) Kaliumcitraat / kaliumwaterstofcarbonaat Levoketoconazole Linzagolix Liraglutide IND Lonafarnib Lonapegsomatropin Lumasiran Maralixibat Migalastat IND Nolasiban Obeticholic acid IND Octreotide Odevixibat Olipudase alfa Osilodrostat Pegunigalsidase alfa Pegvaliase Polyethylene glycol loxenatide Reloxaliase Relugolix IND Relugolix / estradiol / norethisteronen Reparixin Romosozumab Sapropterin G Seladelpar Semaglutide IND Setmelanotide IND Sodium zirconium cyclosilicate Sofpironium bromide Somapacitan Somatrogon Sotagliflozine IND Spheroids of human autologous matrix-associated chondrocytes IND Tenapanor IND Teplizumab Tirzepatide Trientine Triheptanoin Veverimer Vibegron Volanesorsen IND Vosoritide Chronic immune diseases Abrocitinib Adalimumab IND Adrenaline Anakinra IND Anifrolumab Arachis hypogaea (pinda) allergenen (capsule) Arachis hypogaea (pinda) allergenen (pleister) Avacopan Baricitinib IND Belatacept IND Belimumab IND Beremagene geperpavec Berkenschorsextract Berotralstat Bimekizumab Clascoterone Crisaborole Difelikefalin Dupilumab IND Elobixibat Etrolizumab IND Filgotinib Forigerimod Glycopyrronium tosylate Guselkumab IND Icatibant G Imlifidase Lebrikizumab MDR-101 Mavorixafor Mirikizumab Nemolizumab Olokizumab Olopatadine / mometasone Ozanimod IND RP-L201 Regenerative Skin Tissue Remestemcel-L IND Risankizumab Extension of indication for the treatment of active psoriatic arthritis in adults. IND Indicated for CD (ziekte van Crohn) IND Patients with Atopic Dermatitis 12 Years and older. IND Ruxolitinib IND Sarilumab IND Secukinumab IND Spesolimab Sutimlimab Tapinarof Adult Plaque Psoriasis Atopische dermatitis Tenapanor Teprasiran Teprotumumab Tirbanibulin Tocilizumab BS Tofacitinib Treatment of active polyarticular course juvenile idiopathic arthritis patients 2 years of age and older. IND Treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy. IND Tralokinumab Triamcinolone Upadacitinib Upadacitinib is indicated for the treatment of moderate to severe atopic dermatitis in patients who have failed to respond to conventional (topical) therapies. IND Rinvoq is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. IND Rinvoq is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Rinvoq may be used as monotherapy or in combination with methotrexate. IND Moderately to Severely Active Ulcerative Colitis IND Voclosporin Infectious diseases APN01 Amoxicilline / omeprazol / rifabutin Atazanavir / cobicistat Baloxavir marboxil Bamlanivimab/ etesevimab Baricitinib IND Bedaquiline IND Bulevirtide Cabotegravir Casirivimab/imdevimab Ceftaroline fosamil IND Ceftazidime / avibactam Zavicefta is indicated in adults and children aged 3 months and older and adolescents for the treatment of the following infections in adults with Complicated intra-abdominal infection (cIAI), Complicated urinary tract infection (cUTI), including pyelonephritis, Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). IND Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, the currently approved indications for complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI) and hospital-acquired pneumonia, including ventilator-associated pneumonia. IND Ceftobiprole Dapagliflozine IND Delafloxacin IND Delamanid IND Elbasvir / grazoprevir IND Etravirine IND Fostemsavir Glecaprevir / pibrentasvir IND Human normal immunoglobulin IND Ibrexafungerp IND Iclaprim Imipenem / cilastatin / relebactam Recarbrio is indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults. Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults. IND Lefamulin Lenacapavir Liposomaal amikacine Lonafarnib Maribavir Nirsevimab Obiltoxaximab Ozenoxacine Posaconazol IND Pretomanid Regdanvimab Remdesivir Veklury is geïndiceerd voor de behandeling van coronavirus disease 2019 (COVID-19) bij volwassenen en jongeren (vanaf 12 jaar die minstens 40kg wegen) met pneumonie die aanvullende zuurstof nodig hebben. Extension of indication to include treatment of adults with pneumonia not requiring supplemental oxygen (moderate COVID-19). IND Rezafungin SER 109 Sotrovimab Tebipenem Tecovirimat Tedizolid IND Zanamivir Lung diseases Bamocaftor / tezacaftor / ivacaftor Beclometason/formoterol/glycopyrronium Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. IND Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist Benralizumab IND Budesonide / formoterol IND Dupilumab IND Elexacaftor / tezacaftor / ivacaftor Kaftrio is indicated in a combination regimen with ivacaftor 150mg tablets for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene Uitbreiding van Kaftrio in combinatie met ivacaftor voor patienten met tenminste één F508del mutatie naar de leeftijd vanaf 6 jaar (uitbreiding voor 6 tot 11 jarigen) Fluticasone furoate / umeclidinium / vilanterol IND Formoterol / glycopyronium / budesonide Gefapixant Indacaterol acetate/glycopyrronium bromide/mometasone furoate Indacaterol acetate/mometasone furoate Ivacaftor IND Lumacaftor / ivacaftor IND Masitinib Mepolizumab Extension of indication to include Eosinophilic Granulomatosis with Polyangiitis (EGPA) to Nucala IND Extension of indication to include Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) for Nucala (mepolizumab). IND Nintedanib Ofev is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease. IND Ofev is indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases with a progressive phenotype. IND Omalizumab Aanvullende behandeling om de astmacontrole te verbeteren bij patiënten met ernstig persistent allergisch astma. BS Aanvullende behandeling om de astmacontrole te verbeteren bij patiënten met ernstig persistent allergisch astma. BS Aanvullende behandeling om de astmacontrole te verbeteren bij patiënten met ernstig persistent allergisch astma. Ook voor de behandeling van chronische idiopathische urticaria. BS Pirfenidone IND Revefenacin Tezacaftor / ivacaftor IND Tezepelumab Neurological disorders AMDC-USR Aducanumab Aflibercept BS Aganirsen Amantadine Apomorphine Arimoclomol Avacincaptad pegol Bevacizumab-vikg Bidridistrogene xeboparvovec Brexanolone Brimapitide Brivaracetam IND Brolucizumab IND Bupivacaine Bupivacaine / meloxicam Bupropion/dextromethorphan Cannabidiol IND Cannabidiol gel/intradermaal Cenobamate Daridorexant Dexmedetomidine Diroximel fumarate Eladocagene exuparvovec Eptinezumab Erenumab Esketamine Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant major depressive disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode. Extension of indication to include a new indication for SPRAVATO® (esketamine nasal spray) co-administered with oral antidepressant therapy in adults with a moderate to severe episode of Major Depressive Disorder (MDD), as acute short term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency. IND Fampridine G Faricimab Fasinumab Fenfluramine Fintepla is indicated for the treatment of seizures associated with Dravet syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older. Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome IND Fingolimod G Fremanezumab Galcanezumab Ganaxolone Golodirsen Inebilizumab Istradefylline JZP-258 Lacosamide IND Lasmiditan Latanoprostene bunod Lemborexant Lenadogene nolparvovec Leuco-methylthioninium Alzheimer’s disease, mild-to-moderate. Dementia, behavioural variant frontotemporal. Levodopa / carbidopa Lidocaïne Lisdexamfetamine IND Lumateperone Lurasidone IND Masitinib Meloxicam/rizatriptan Mexiletine HCl Molindone Natalizumab Natriumoxybaat IND Natriumoxybaat controlled release Neridronic Acid Netarsudil / latanoprost Ofatumumab Olanzapine / samidorphan Onasemnogene abeparvovec Perampanel IND Perfluorohexyloctane Pioglitazone Pitolisant IND Polihexanide Ponesimod Ranibizumab Wet age-related macular degeneration (AMD). BS Wet age-related macular degeneration (AMD). BS Wet age-related macular degeneration (AMD). BS Wet age-related macular degeneration (AMD). BS Treatment of neovascular age-related macular degeneration (AMD) Remimazolam Reproxalap Rimegepant Risdiplam Ronopterin SDN037 Satralizumab Sepofarsen Siponimod Sugammadex G Tanezumab Treatment of moderate to severe chronic pain associated with OA of the hip or knee in adult patients for whom treatment with NSAIDs and/or any opioid is ineffective, not tolerated or inappropriate Chronic Low Back Pain for ≥3 months IND Tasimelteon IND Teriflunomide IND Timrepigene emparvovec Tiratricol Voretigene neparvovec Zuranolone Cardiovascular diseases Allogenic immunomodulatory progenitor cells Apabetalon Apixaban G Avatrombopag Bempedoic acid Bempedoic acid / ezetimibe Betibeglogene autotemcel Zynteglo is geïndiceerd voor gebruik bij patiënten in de leeftijd van 12 jaar en ouder met transfusie-afhankelijke β-thalassemie (transfusion-dependent β-thalassaemia - TDT) die geen β0/β0-genotype hebben, voor wie transplantatie van hematopoëtische stamcellen (HSC) gepast is, maar geen humaan leukocytenantigeen (HLA)-compatibele gerelateerde HSC-donor beschikbaar is. Behandeling van patiënten jonger dan 12 jaar met transfusie-afhankelijke β-thalassemie (TDT) die geen β0/β0-genotype hebben en voor wie hematopoïetische stamceltransplantatie (HSC) gepast is, maar voor wie geen humaan leukocyt antigeen (HLA)-compatibele verwante HSC-donor beschikbaar is. IND Behandeling van patiënten met transfusie-afhankelijke β-thalassemie (TDT) die een β0 mutatie op beide allelen van het β-globuline (HBB) hebben, en voor wie hematopoïetische stamceltransplantatie (HSC) gepast is, maar voor wie geen humaan leukocyt antigeen (HLA)-compatibele verwante HSC-donor beschikbaar is IND Crizanlizumab Dabigatran G Dabigatran etexilate IND Dapagliflozine Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. IND Chronic Heart Failure With Preserved Ejection Fraction (HFpEF). IND Daprodustat Deferasirox G Eculizumab Paroxysmal nocturnal haemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) BS Paroxysmal nocturnal haemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) BS Paroxysmal nocturnal haemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). BS Efgartigimod Emiplacel Empagliflozine Chronic Heart Failure With Preserved Ejection Fraction (HFpEF). IND Jardiance is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. IND Eptacog beta (activated) Etranacogene dezaparvovec Evinacumab Evolocumab IND FLT180a Ferumoxytol Fibrinogen Fidanacogene elaparvovec Hydroxycarbamide IND Icosapent ethyl Inclisiran Luspatercept IND Macitentan IND Mepolizumab IND Mitapivat Omecamtiv mecarbil Pegcetacoplan RP-L102 Ravulizumab Extension of Indication to include the treatment of patients with atypical hemolytic uremic syndrome (aHUS). IND Treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) in patients with haemolysis with clinical symptom(s) indicative of high disease activity and in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. Extension of indication to include treatment of paediatric patients with paroxysmal nocturnal haemoglobinuria (PNH) for Ultomiris. IND Rilonacept Rivaroxaban IND Romiplostim IND Roxadustat Tafamidis IND Thrombomodulin alfa Ticagrelor Extension of indication to include, in co administration with acetylsalicylic acid (ASA), the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) without a history of myocardial infarction who have undergone percutaneous coronary intervention (PCI). IND Extension of indication to include, in co-administration with acetylsalicylic acid (ASA), the prevention of stroke in adult patients with acute ischaemic stroke or transient ischaemic attack (TIA) in the previous 24 hours. IND Udenafil Vadadustat Valsartan / sacubitril IND Vericiguat Voxelotor Older publications Published on 8 December 2020 Published on 10 June 2020 Published on 10 December 2019 Published on 12 June 2019 Published on 13 December 2018 Published on 12 June 2018 Published on 9 January 2018