ADHD Lisdexamfetamine IND Melatonine Molindone ALL Blinatumomab 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 autologous anti-CD19-transduced CD3+ cells IND ALS Arimoclomol IND AML / MDS Azacitidine Eprenetapopt Glasdegib Idasanutlin Imetelstat Iomab-B Pevonedistat Sapacitabine Venetoclax IND Aggressive non-Hodgkin’s lymphoma Axicabtagene ciloleucel IND Crizotinib IND Ibrutinib IND Lisocabtagene maraleucel Pirtobrutinib Tafasitamab Tagraxofusp Zamtocabtagene autoleucel Zanubrutinib IND loncastuximab tesirine Antithrombotic medications Dabigatran G Dabigatran etexilate IND Ravulizumab IND Asthma Budesonide / formoterol IND Dupilumab IND Masitinib Tezepelumab Bacterial infections Bedaquiline IND Ceftobiprole Ceftolozane / tazobactam IND Citric acid / lactic acid / potassium bitartrate IND Clindamycin 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 Eravacycline 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 Ozenoxacine SER 109 Tebipenem Bladder cancer Avelumab IND Durvalumab IND Enfortumab vedotin Nivolumab IND Oportuzumab monatox Bowel diseases Etrolizumab IND Filgotinib IND Mirikizumab Ozanimod IND Risankizumab IND Tenapanor Upadacitinib IND Vedolizumab IND Brain cancer Autologous glioma tumor cell lysates Vocimagene amiretrorepvec Breast cancer Abemaciclib IND 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 1L advanced or mTNBC +cobimetinib+(nab)paclitaxel IND Balixafortide Efbemalenograstim alfa Margetuximab Neratinib IND Olaparib 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 Pertuzumab / trastuzumab Sacituzumab govitecan Tesetaxel 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 Trastuzumab duocarmazine Tucatinib CLL 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). Duvelisib 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 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 Moxetumomab pasudotox Ublituximab Zanubrutinib IND ibrutinib IND CML Asciminib COPD Beclometason/formoterol/glycopyrronium COVID-19 APN01 Anakinra IND Bamlanivimab/ etesevimab Baricitinib IND Casirivimab/imdevimab Dapagliflozine IND Molnupiravir PF-07321332 / ritonavir Regdanvimab IND Remdesivir IND Sotrovimab Tocilizumab IND Cardiovascular diseases Avacopan Cervical cancer Cemiplimab IND Lifileucel Colon cancer Eflornithine / sulindac Nivolumab IND Tegafur / gimeracil / oteracil IND Cystic fibrosis 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 Ivacaftor IND Tezacaftor / ivacaftor IND Dementia Aducanumab Depression Bupropion/dextromethorphan 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 Zuranolone Diabetes Bexagliflozine Dapagliflozine IND Dasiglucagon 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 Finerenon Polyethylene glycol loxenatide Reparixin Sotagliflozine IND Teplizumab Tirzepatide Duchenne Golodirsen Epilepsy Brivaracetam IND Cannabidiol IND Cenobamate 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 Ganaxolone Lacosamide IND Eye disorders Aflibercept IND Avacincaptad pegol Bevacizumab-vikg Brolucizumab IND Faricimab Lenadogene nolparvovec Netarsudil / latanoprost Perfluorohexyloctane Phentolamine 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) Reproxalap Sepofarsen Timrepigene emparvovec Fungal infections Ibrexafungerp IND Oteseconazole 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 Rezafungin HIV Atazanavir / cobicistat Cabotegravir Fostemsavir Lenacapavir Head and neck cancer Leukocyte interleukin Pembrolizumab IND Headache Atogepant Dihydroergotamine Eptinezumab Erenumab Fremanezumab Galcanezumab Lasmiditan Meloxicam / rizatriptan Rimegepant Hemostasis promoting medication Eptacog alfa (activated) BS Eptacog beta (activated) Etranacogene dezaparvovec FLT180a Fibrinogen Valoctocogene roxaparvovec Indolent non-Hodgkin’s lymphoma Axicabtagene ciloleucel IND Copanlisib Hypericin Lacutamab Mosunetuzumab Umbralisib Infectious diseases other Fluticasone propionate Tixagevimab / cilgavimab Kidney cancer Avelumab IND Cabozantinib IND Lenvatinib IND Pembrolizumab 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 Extension of indication for Keytruda to include in combination with lenvatinib first line treatment of adults with advanced renal cell carcinoma (RCC). IND Tivozanib IND Lipid-lowering medications Bempedoic acid Bempedoic acid / ezetimibe Evinacumab Evolocumab IND Inclisiran Liver cancer Durvalumab 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 Lenvatinib IND Pembrolizumab IND Pemigatinib Tremelimumab Liver diseases Cenicriviroc Givosiran 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 Obeticholic acid Odevixibat Seladelpar Lung cancer Amivantamab Atezolizumab 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 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 Avelumab IND Capmatinib Cemiplimab 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 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 Durvalumab Non-small cell lung cancer (NSCLC) stage IV, in combination with tremelimumab and chemo,1L. 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 Ensartinib Entrectinib Lorlatinib IND Lurbinectedin Mobocertinib Nivolumab IND OSE-2101 Osimertinib IND Pralsetinib Selpercatinib Sotorasib Tepotinib Trastuzumab deruxtecan IND Trilaciclib pembrolizumab IND Lung diseases other Ambrisentan IND Benralizumab IND Gefapixant 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 IND Lung other Pirfenidone G Mesothelioma Nivolumab IND Metabolic diseases 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 Cipaglucosidase alfa / Miglustat Elamipretide Elivaldogene autotemcel Fexapotide Fosdenopterin Hydrocortison Kaliumcitraat / kaliumwaterstofcarbonaat Leriglitazone Levoketoconazole Liraglutide IND Lonafarnib Migalastat IND Octreotide Olenasufligene relduparvovec Olipudase alfa Palovarotene Pegunigalsidase alfa Pegvaliase Reloxaliase Sapropterin G Somatrogon Sparsentan Tenapanor IND Trientine Triheptanoin Veverimer Multiple Myeloma 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 Carfilzomib IND Ciltacabtagene autoleucel 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 Idecabtagene vicleucel 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 Lenalidomide IND Melphalan flufenamide IND Pomalidomide IND 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 Thalidomide G Zevorcabtagene autoleucel Multiple sclerosis 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 Natalizumab Ofatumumab Ponesimod 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 Ublituximab Muscular diseases other AMDC-USR Amifampridine G Bidridistrogene xeboparvovec Sugammadex G Myeloproliferative disorders Fedratinib Momelotinib Ropeginterferon alfa-2b Neuroendocrine cancer Selumetinib Surufatinib Neurological disorders other Cannabidiol gel/intradermaal Eladocagene exuparvovec Inebilizumab Remimazolam Rozanolixizumab Satralizumab Tiratricol Vutrisiran Oncology other 131I-omburtamab Dostarlimab Durvalumab IND Entrectinib Futibatinib Glucarpidase Ivosidenib IND Larotrectinib 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 Advanced or Recurrent Endometrial Cancer (1L) in combination with pembrolizumab IND Lipegfilgrastim IND NY-ESO-1 autologous engineered TCR-T cells Nivolumab 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 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 Pembrolizumab 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 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 Retifanlimab Selinexor IND Sodium thiosulfate Tebentafusp Other chronic immune diseases Adrenaline Arachis hypogaea (pinda) allergenen (capsule) Arachis hypogaea (pinda) allergenen (pleister) 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 Berotralstat Budesonide modified released capsule IND Canakinumab IND Icatibant G Imlifidase MDR-101 Mavorixafor RP-L201 Sutimlimab Teprotumumab Voclosporin Other hematology Zanubrutinib Other medication for cardiovascular diseases Allogenic immunomodulatory progenitor cells Angiotensin II Apabetalon Dapagliflozine IND 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 Etripamil Icosapent ethyl Macitentan IND Macitentan / tadalafil Mavacamten Omecamtiv mecarbil Rexlemestrocel-L Rilonacept Sotagliflozine IND Tafamidis IND Udenafil Vericiguat Other metabolism and Endocrinology Burosumab IND Corifollitropin alfa IND Dapagliflozine IND Diazoxide choline (controlled-release tablet) Drospirenon / estetrol, monohydraat Empagliflozine IND Levonorgestrel G Linzagolix Lonapegsomatropin Lumasiran Osilodrostat Ospemifene Relugolix IND Relugolix / estradiol / norethisteronen 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 Spheroids of human autologous matrix-associated chondrocytes IND Vosoritide Other non-oncological hematological medications Avatrombopag 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 Daprodustat Efgartigimod Eptacog alfa (activated) IND Horse anti-human T lymphocyte immunoglobulin Hydroxycarbamide IND Luspatercept IND Mepolizumab IND Mitapivat Pegcetacoplan RP-L102 Ravulizumab 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 Roxadustat UM171 Vadadustat Voxelotor Other psychiatry Dexmedetomidine Ovarian cancer Niraparib IND Pain Bupivacaine extended release IND Fasinumab Lidocaïne Neridronic Acid SDN037 Tanezumab Pancreatic cancer Eryaspase (asparaginase) Parkinson's Amantadine Istradefylline Levodopa / carbidopa Prostate cancer 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 DCVAC 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 Degarelix IND Enzalutamide IND Gozetotide Lutetium (177lu) vipivotide tetraxetan Masitinib Niraparib / abiraterone Olaparib IND Pembrolizumab IND Relugolix pembrolizumab IND Rheumatism Anifrolumab Cyclobenzaprine hydrochloride Risankizumab IND Sarilumab IND Secukinumab IND 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 SMA Onasemnogene abeparvovec Risdiplam Schizophrenia, psychosis, bipolar disorder Lumateperone Skin cancer Cemiplimab IND Darleukin fibromun Lifileucel Pembrolizumab 1L treatment with pembrolizumab for advanced melanoma, in combination with lenvatinib. 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 Relatlimab Seviprotimut-L Tavokinogene telseplasmid Skin diseases Abrocitinib Beremagene geperpavec Berkenschorsextract Bimekizumab Crisaborole Deucravacitinib Difelikefalin Lebrikizumab Ligelizumab Regenerative Skin Tissue Risankizumab IND Ruxolitinib Secukinumab IND Spesolimab Tapinarof Adult Plaque Psoriasis Atopische dermatitis Tirbanibulin Tralokinumab Upadacitinib IND Sleep disorders Daridorexant JZP-258 Natriumoxybaat controlled release Pitolisant Stem cell transplants Inolimomab Motixafortide Narsoplimab Omidubicel Remestemcel-L Ruxolitinib IND Tabelecleucel Tisagenlecleucel-T IND autologous anti-CD19-transduced CD3+ cells Stomach cancer Avapritinib Nivolumab IND Ripretinib Rivoceranib Trastuzumab deruxtecan IND Zolbetuximab Thyroid cancer Cabozantinib IND Selpercatinib 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). Unknown Olopatadine / mometasone Viral infections other Baloxavir marboxil Bizalimogene ralaplasmid Bulevirtide Doravirine / lamivudine / tenofovirdisoproxil IND Elbasvir / grazoprevir IND Glecaprevir / pibrentasvir IND Lonafarnib IND Maribavir Nirsevimab Sofosbuvir / velpatasvir / voxilaprevi IND Tecovirimat sofosbuvir / velpatasvir IND