Published on 7 December 2021 Oncology and Hematology 131I-omburtamab 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 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). Amivantamab 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 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 1L advanced or mTNBC +cobimetinib+(nab)paclitaxel IND Extension of indication to include adjuvant treatment of non-small cell lung cancer (NSCLC) following resection and platinum-based chemotherapy for adult patients whose tumours have PD-L1 expression on ≥ 1% of tumour cells (TC). 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 Extension of indication to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy. IND Recidiverend of refractair na 1 of meer lijnen van therapie DLBCL, transplant-eligible. 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 IND Cabozantinib Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. IND Cabozantinib monotherapy in adults and adolescent patients (aged 12 years and older) with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not candidates to radioactive iodine (RAI) who have progressed during or after prior systemic therapy IND Capmatinib Carfilzomib IND Cemiplimab 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 Ciltacabtagene autoleucel Copanlisib Crizotinib IND 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 Multipel myeloom frontline behandeling in combinatie met VRd voor patiënten die niet in aanmerking komen voor een ASCT. 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 Degarelix IND Dostarlimab Durvalumab Non-small cell lung cancer (NSCLC) stage IV, in combination with tremelimumab and chemo,1L. 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 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 Eryaspase (asparaginase) Fedratinib Futibatinib Glasdegib Glucarpidase Gozetotide Hypericin Ibrutinib 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 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 Ivosidenib IND Lacutamab 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 IND KISPLYX is indicated for the treatment of adults with advanced renal cell carcinoma (RCC) in combination with pembrolizumab, as first-line treatment. IND Advanced Hepatocellular Carcinoma (1L) in combination with pembrolizumab IND Advanced or Recurrent Endometrial Cancer (1L) in combination with pembrolizumab IND Leukocyte interleukin Lifileucel Maliganant melanoma, advanced melanoma. Treatment of Patients With Cervical Carcinoma (2L) Lipegfilgrastim IND Lisocabtagene maraleucel Lorlatinib IND Lurbinectedin Lutetium (177lu) vipivotide tetraxetan Margetuximab Masitinib Melphalan flufenamide IND Mobocertinib Momelotinib Mosunetuzumab Motixafortide Moxetumomab pasudotox NY-ESO-1 autologous engineered TCR-T cells Narsoplimab Neratinib IND Niraparib IND Niraparib / abiraterone 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 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 Opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy IND Extension of indication to include in combination with fluoropyrimidineand platinum-based combination chemotherapy the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) for OPDIVO. IND OSE-2101 Olaparib Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer. 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 Extension of indication for Keytruda in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery of adults with locally advanced, inflammatory, or earlystage triple-negative breast cancer at high-risk of recurrence. IND Adjuvant treatment in monotherapy of adults with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. 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 a new indication for Keytruda, in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent, or metastatic cervical cancer in adults. 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, 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 1L treatment with pembrolizumab for advanced melanoma, in combination with lenvatinib. IND 3L treatment of metastatic castration-resistant prostate cancer (mCRPC), after NHa and chemotherapy treatment (extensively pretreated mCRPC ) combined with Olaparib IND Extension of indication for Keytruda as monotherapy in the treatment of unresectable or metastatic MSI-H or dMMR colorectal, endometrial, gastric, small intestine, biliary, or pancreatic cancer in adults who have received prior therapy. IND Extension of indication to include the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, Stage IIC or stage III melanoma and to include the treatment of adolescents aged 12 years and older with advanced melanoma for Keytruda IND Pemigatinib Pertuzumab / trastuzumab Pevonedistat Pirtobrutinib Pomalidomide IND Pralsetinib Relatlimab Relugolix Remestemcel-L Retifanlimab Ripretinib Rivoceranib Ropeginterferon alfa-2b 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 Tebentafusp Tegafur / gimeracil / oteracil IND Tepotinib Tesetaxel Thalidomide G Tisagenlecleucel-T IND 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. Extension of indication to include monotherapy treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior anti-HER2-based regimen IND 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 adult patients with HER2-mutated, Unresectable and/or Metastatic non-small cell lung cancer (NSCLC). IND Trastuzumab duocarmazine Tremelimumab Trilaciclib Tucatinib Ublituximab Umbralisib Venetoclax IND Vocimagene amiretrorepvec Zamtocabtagene autoleucel Zanubrutinib Mantle-cell lymphoma (1L) + Rituximab. IND 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. Previously Untreated CLL or SLL IND Zevorcabtagene autoleucel Zolbetuximab 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. Extension of indication to include treatment of adult patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukaemia (B-ALL) for Tecartus. IND ibrutinib IND loncastuximab tesirine pembrolizumab 1L Treatment with pembrolizumab for treatment-naïve adults with no prior systemic therapy for metastatic non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expresssion of TPS ≥1%, in combination with lenvatinib IND Treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA). 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 Avalglucosidase alfa Bardoxolone Methyl Betaine G Bexagliflozine Burosumab IND Cenicriviroc Cipaglucosidase alfa / Miglustat Corifollitropin alfa IND Dapagliflozine Forxiga is indicated in adults for the treatment of 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 Empagliflozine IND Exenatide Diabetes type 2 Extension of indication to include the treatment of type 2 diabetes in adolescents and children aged 10 years and above IND Fexapotide Finerenon Fosdenopterin Givosiran Hydrocortison Kaliumcitraat / kaliumwaterstofcarbonaat Leriglitazone Levoketoconazole Levonorgestrel G Linzagolix Liraglutide IND Lonafarnib Lonapegsomatropin Lumasiran Maralixibat Progressive Familial Intrahepatic Cholestasis Type 2 Treatment of Progressive Familial Intrahepatic Cholestasis Type 2 Treatment of cholestatic liver disease in patients with Alagille syndrome (ALGS) 1 year of age and older. IND Migalastat IND Obeticholic acid Octreotide Odevixibat Olenasufligene relduparvovec Olipudase alfa Osilodrostat Ospemifene Palovarotene Pegunigalsidase alfa Pegvaliase Polyethylene glycol loxenatide Reloxaliase Relugolix IND Relugolix / estradiol / norethisteronen Reparixin Sapropterin G Seladelpar Semaglutide IND Setmelanotide Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years of age and above. Treatment of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS). IND Sofpironium bromide Somapacitan Somatrogon Sotagliflozine IND Sparsentan Spheroids of human autologous matrix-associated chondrocytes IND Tenapanor IND Teplizumab Tirzepatide Trientine Triheptanoin Veverimer Vosoritide Chronic immune diseases Abrocitinib Adrenaline Anifrolumab Arachis hypogaea (pinda) allergenen (capsule) Arachis hypogaea (pinda) allergenen (pleister) Avacopan Baricitinib Systemic lupus erythematosus IND Extension of indication to include treatment of severe alopecia areata in adult patients for Olumiant. IND Belatacept IND Belimumab IND Beremagene geperpavec Berkenschorsextract Berotralstat Bimekizumab Budesonide modified released capsule IND Canakinumab IND Crisaborole Cyclobenzaprine hydrochloride Deucravacitinib Difelikefalin Etrolizumab IND Filgotinib IND Icatibant G Imlifidase Lebrikizumab Ligelizumab MDR-101 Mavorixafor Mirikizumab Olopatadine / mometasone Ozanimod IND RP-L201 Regenerative Skin Tissue Risankizumab Indicated for CD (ziekte van Crohn) IND Patients with Atopic Dermatitis 12 Years and older. IND Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). IND Ruxolitinib Sarilumab IND Secukinumab Hidradenitis Suppurativa (HS) IND Extension of indication to include treatment of Juvenile Idiopathic Arthritis (EnthesitisRelated Arthritis and Juvenile Psoriatic Arthritis) in patients 2 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy for Cosentyx. IND Spesolimab Sutimlimab Tapinarof Adult Plaque Psoriasis Atopische dermatitis Tenapanor Teprotumumab Tirbanibulin Tofacitinib Tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive or negative polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs. Tofacitinib can be given in combination with methotrexate (MTX) or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. IND Extension of indication for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy. IND Tralokinumab Upadacitinib Rinvoq is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. IND Moderately to Severely Active Ulcerative Colitis IND Vedolizumab IND Voclosporin Infectious diseases APN01 Anakinra IND Atazanavir / cobicistat Baloxavir marboxil Bamlanivimab/ etesevimab Baricitinib IND Bedaquiline IND Bizalimogene ralaplasmid Bulevirtide Cabotegravir Casirivimab/imdevimab Ceftobiprole Ceftolozane / tazobactam IND Citric acid / lactic acid / potassium bitartrate IND Clindamycin Dapagliflozine IND Delafloxacin IND Delamanid Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents and children with a body weight of at least 30kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. IND Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, and children and infants with a body weight of at least 10kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. IND Doravirine / lamivudine / tenofovirdisoproxil IND Elbasvir / grazoprevir IND Eravacycline Fluticasone propionate Fostemsavir Glecaprevir / pibrentasvir IND Ibrexafungerp IND 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 Lenacapavir Lonafarnib IND Maribavir Molnupiravir Nirsevimab Oteseconazole Ozenoxacine PF-07321332 / ritonavir Posaconazol Extension of indication to include primary treatment of invasive aspergillosis in adults and adolescents from 13 years of age for Noxafil gastroresistant tablet and concentrate for solution for infusion. IND Extension of indication to include primary treatment of invasive aspergillosis in paediatric patients from 2 years of age weighing more than 40kg and adults for Noxafil gastroresistant tablet and concentrate for solution for infusion. Noxafil gastro-resistant tablets and solution are indicated for use in the treatment of the following fungal infections: Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products. IND Regdanvimab IND Remdesivir IND Rezafungin SER 109 Sofosbuvir / velpatasvir / voxilaprevi IND Sotrovimab Tebipenem Tecovirimat Tixagevimab / cilgavimab Tocilizumab IND sofosbuvir / velpatasvir IND Lung diseases Ambrisentan IND Beclometason/formoterol/glycopyrronium 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. Kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene Gefapixant 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 Pirfenidone Extension of indication to include the treatment of unclassifiable interstitial lung disease (UILD) for Esbrie. IND Lichte tot matige idiopathische pulmonale fibrose (IPF) bij volwassenen. G Tezacaftor / ivacaftor IND Tezepelumab Neurological disorders AMDC-USR Aducanumab Aflibercept IND Amantadine Amifampridine G Arimoclomol IND Atogepant Avacincaptad pegol Bevacizumab-vikg Bidridistrogene xeboparvovec Brivaracetam IND Brolucizumab IND Bupivacaine extended release IND Bupropion/dextromethorphan Cannabidiol IND Cannabidiol gel/intradermaal Cenobamate Daridorexant Dexmedetomidine Dihydroergotamine Dimethyl fumarate Extension of indication to include treatment of relapsing remitting multiple sclerosis (RRMS) in paediatrics patients from 10 years of age and over. IND Volwassenen met 'relapsing remitting' multipele sclerose (RRMS). G Volwassenen met 'relapsing remitting' multipele sclerose (RRMS). G Volwassenen met 'relapsing remitting' multipele sclerose (RRMS). G 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 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 Fremanezumab Galcanezumab Ganaxolone Golodirsen Inebilizumab Istradefylline JZP-258 Lacosamide IND Lasmiditan Lenadogene nolparvovec Levodopa / carbidopa Lidocaïne Lisdexamfetamine IND Lumateperone Melatonine Meloxicam / rizatriptan Molindone Natalizumab Natriumoxybaat controlled release Neridronic Acid Netarsudil / latanoprost Ofatumumab Onasemnogene abeparvovec Perfluorohexyloctane Phentolamine Pitolisant 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 Rozanolixizumab SDN037 Satralizumab Sepofarsen Sugammadex G Tanezumab Teriflunomide Aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis. IND Volwassenen met 'relapsing remitting' multipele sclerose (RRMS). G Timrepigene emparvovec Tiratricol Ublituximab Vutrisiran Zuranolone Cardiovascular diseases Allogenic immunomodulatory progenitor cells Angiotensin II Apabetalon 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 IND Daprodustat Efgartigimod Emiplacel Empagliflozine Chronic Heart Failure With Preserved Ejection Fraction (HFpEF, LVEF >40%). IND Jardiance is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. IND Eptacog alfa (activated) Extension of indication to include treatment of severe postpartum haemorrhage IND Preventie en behandeling van bloedingen bij operaties of invasieve ingrepen bij: 1) overgeërfde hemofilie met remmers tegen stollingsfactor VIII of IX (> 5 BU) of bij een verwachte hoge anamnestische respons op factor VIII of factor IX 2) verworven hemofilie 3) overgeërfde factor VII-deficiëntie 4) ziekte van Glanzmann (trombasthenie) met eerdere of huidige ongevoeligheid voor bloedplaatjestransfusie of wanneer bloedplaatjes niet direct beschikbaar zijn. BS Eptacog beta (activated) Etranacogene dezaparvovec Etripamil Evinacumab Evolocumab IND FLT180a Fibrinogen Horse anti-human T lymphocyte immunoglobulin Hydroxycarbamide IND Icosapent ethyl Inclisiran Luspatercept IND Macitentan IND Macitentan / tadalafil Mavacamten 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 (>10 kg). IND Rexlemestrocel-L Rilonacept Roxadustat Sotagliflozine IND Tafamidis IND UM171 Udenafil Vadadustat Valoctocogene roxaparvovec Vericiguat Voxelotor Older publications Published on 8 June 2021 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