Published on 7 June 2022 Oncology 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 Adagrasib Afamitresgene autoleucel Amcenestrant Amivantamab Atezolizumab Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) 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) for Tecentriq as monotherapy IND Autologous glioma tumor cell lysates 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 Balixafortide 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 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 Extension of indication to include LIBTAYO in combination with platinum‐based chemotherapy for the first-line treatment of adult patients with locally advanced NSCLC who are not candidates for definitive chemoradiation or metastatic NSCLC with no EGFR, ALK or ROS1 aberrations, independen of PD-L1 expression. IND Extension of indication to include monotherapy treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. 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 Degarelix IND Dostarlimab Jemperli is indicated as monotherapy for the Treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum‑containing regimen. Stage III or IV non mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (collectively referred to as "ovarian cancer") IND Durvalumab Extension of indication to include first-line treatment, with Imfinzi in combination with tremelimumab and platinum-based chemotherapy, of adults with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumour aberrations. 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 1L advanced NSCLC IND Completely resected NSCLC IND Lokaal gevorderd, niet-resectabel NSCLC (stadium III) IND Durvalumab (+/- bevacizumab) in combinatie met TACE in patiënten met locoregionale HCC. IND Extension of indication to include IMFINZI in combination with chemotherapy for the treatment of adults with locally advanced or metastatic biliary tract cancer (BTC). IND Extension of indication to include IMFINZI in combination with tremelimumab for the treatment of adults with unresectable hepatocellular carcinoma (uHCC). IND Limited stage small cell lung cancer (LS-SCLC) following concurrent platinum-based chemotherapy and radiation therapy in combination with Tremelimumab. IND Locally advanced cervical cancer IND Unresectable locally advanced or metastatic urothelial cancer in combination with tremelimumab and chemotherapy IND Efbemalenograstim alfa Enfortumab vedotin Ensartinib Erdafitinib Futibatinib Glucarpidase Inbakicept Infigratinib Ivosidenib IND Jodium (131I) omburtamab 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 Advanced or Recurrent Non Small Cell Lung Cancer (1L, non squamous) in combination with pembrolizumab. IND Unresectable Advanced Melanoma (1L) in combination with pembrolizumab. IND Leuprolide mesylate Lifileucel Lipegfilgrastim IND Lorlatinib IND Lurbinectedin Lutetium (177lu) vipivotide tetraxetan Masitinib Mirvetuximab soravtansine Mobocertinib NY-ESO-1 autologous engineered TCR-T cells Neratinib 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 Extension of indication for Opdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, 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 Extension of indication to include OPDIVO in combination with platinum-based chemotherapy for neoadjuvant treatment of adult patients with resectable Stage IB-IIIA non-small cell lung cancer (NSCLC). 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 treatment of adults with metastatic castration resistant prostate cancer (mCRPC), with Lynparza in combination with abiraterone and prednisone or prednisolone IND Osimertinib IND Paclitaxel Palbociclib Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery. IND Patients with HR+/HER2- invasive early breast cancer in combination with standard adjuvant endocrine therapy. IND 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, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early‑stage triple‑negative breast cancer at high risk of recurrence. 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 adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. IND Keytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD‑L1 with a CPS ≥ 1. 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 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 Keytruda as monotherapy is indicated for the treatment of the following MSI‑H or dMMR tumours in adults with: unresectable or metastatic colorectal cancer after previous fluoropyrimidine‑based combination therapy; advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum‑containing therapy in any setting and who are not candidates for curative surgery or radiation; unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. 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 Extension of indication to include Keytruda as monotherapy for the adjuvant treatment of adults with Stage IB (T2a ≥ 4 cm), II or IIIA non-small cell lung carcinoma (NSCLC) who have undergone complete resection. IND Pemigatinib Pralsetinib Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer. Gavreto is indicated for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy following prior treatment with Tyrosine Kinase inhibitors and not previously treated with a RET inhibitor. Gavreto is indicated for the treatment of adults and pediatric patients 12 years of age and older with locally advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy following prior treatment with Tyrosine kinase inhibitors and not previously treated with a RET inhibitor. IND Relatlimab Relugolix Ripretinib Sacituzumab govitecan Selinexor IND Selpercatinib 1L treatment advanced or metastatic RET fusion-positive thyroid cancer (TC) IND 1L treatment of adults and children >12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC). IND Retsevmo as monotherapy is indicated for the treatment of adults with advanced RET fusion positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. IND Selumetinib Sintilimab Sirolimus IND Sodium thiosulfate Sotorasib Surufatinib Tebentafusp Tegafur / gimeracil / oteracil IND Tepotinib Tesetaxel Tislelizumab 2L ESCC (esophageal squamous-cell carcinoma) IND 2L NSCLC: monotherapy, is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer in adults who have received at least one prior chemotherapy regimen. Tivozanib IND Toripalimab 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 for Enhertu to include treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. IND 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 HER2-mutated, Unresectable and/or Metastatic non-small cell lung cancer (NSCLC). IND Trastuzumab duocarmazine Tremelimumab Extension of indication in combination with durvalumab for the treatment of adults with unresectable hepatocellular carcinoma (uHCC). IND Treatment of adults with metastatic NSCLC with no sensitising epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumour aberrations. Treosulfan IND Trilaciclib Tucatinib Zolbetuximab Hematology 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). Asciminib Axicabtagene ciloleucel Recidiverend of refractair na 1 of meer lijnen van therapie DLBCL, transplant-eligible. IND Yescarta is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy. IND Extension of indication to include treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) IND Azacitidine Belantamab mafodotin IND Brexucabtagene autoleucel 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 Carfilzomib IND Ciltacabtagene autoleucel Copanlisib Crizotinib IND Cytarabine / daunorubicin (liposomaal) 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 Smouldering multipel myeloom. IND Dasatinib G Decitabine/cedazuridine Duvelisib Elranatamab Eltrombopag IND Eprenetapopt Glasdegib Hypericin Ibrutinib Mantle cell lymphoma (MCL), 1L. IND Extension of the existing CLL indication to include combination treatment with venetoclax for previously untreated patients IND Extension of indication to include treatment with Imbruvica in combination with bendamustine and rituximab (BR) of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for autologous stem cell transplantation 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 Ixazomib IND Lacutamab Lisocabtagene maraleucel Loncastuximab tesirine Melphalan flufenamide IND Momelotinib Mosunetuzumab Motixafortide Navitoclax Obecabtagene autoleucel Omidubicel Parsaclisib Pirtobrutinib Mantle Cell Lymphoma (MCL) Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) IND Polatuzumab vedotin IND Pomalidomide IND Ponatinib IND Ropeginterferon alfa-2b Ruxolitinib IND Selinexor IND Tabelecleucel Tafasitamab Teclistimab Thalidomide G Tisagenlecleucel-T IND Ublituximab Umbralisib 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 Patients With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma IND 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. Extension of indication to include treatment of adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic leukaemia (SLL) IND Extension of indication to include treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one-prior anti-CD20-based therapy IND Zevorcabtagene autoleucel Metabolism and Endocrinology Abaloparatide 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 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 Empagliflozine IND Exenatide IND Fexapotide Fezolinetant Finerenon Kerendia is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults. Extension of indication to include the treatment of chronic kidney disease (CKD) and for the prevention of cardiovascular (CV) events in adults with CKD (regardless of the stage of albuminuria) associated with type 2 diabetes IND Fosdenopterin Hydrocortison Insulin lispro G Leriglitazone Levoketoconazole Levonorgestrel G Linzagolix Liraglutide IND Lonafarnib Lonapegsomatropin Lumasiran Maralixibat IND Migalastat IND Mirabegron IND Obeticholic acid Octreotide Olenasufligene relduparvovec Olipudase alfa Osilodrostat Ospemifene Palovarotene Pegunigalsidase alfa Polyethylene glycol loxenatide Reloxaliase Relugolix IND Relugolix / estradiol / norethisteronen Sapropterin G Seladelpar Semaglutide 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 Somatrogon Sotagliflozine IND Sparsentan Teplizumab Tirzepatide Vosoritide Chronic immune diseases Abrocitinib Adrenaline Anifrolumab Arachis hypogaea (pinda) allergenen (pleister) Avacopan Avapritinib IND Baricitinib Systemic lupus erythematosus IND Extension of indication to include treatment of severe alopecia areata in adult patients for Olumiant. IND Beremagene geperpavec Berkenschorsextract Berotralstat Budesonide modified released capsule IND Canakinumab IND Coacillium topical Cyclobenzaprine hydrochloride Deucravacitinib Difelikefalin Dupilumab Dupixent is geïndiceerd bij kinderen van 6 maanden tot 6 jaar met ernstige atopische dermatitis die in aanmerking komen voor systemische behandeling. IND Dupixent is geïndiceerd bij volwassenen en adolescenten van 12 jaar en ouder voor de behandeling van eosinofiele oesofagitis die onvoldoende onder controle zijn door, of die intolerant zijn voor, of die geen kandidaat zijn voor conventionele medicamenteuze therapie. IND Dupixent is geïndiceerd bij volwassenen voor de behandeling van Prurigo Nodularis die onvoldoende onder controle zijn met topische behandelingen, of wanneer deze behandelingen niet gepast zijn. IND Etrolizumab IND FCR 001 Filgotinib IND Icatibant G Lebrikizumab Ligelizumab Mavorixafor Mirikizumab OTL 103 Olopatadine / mometasone Ozanimod IND RP-L201 Regenerative Skin Tissue Risankizumab Indicated for CD (ziekte van Crohn) 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 Roflumilast topical Ruxolitinib phosphate Sarilumab IND Secukinumab Hidradenitis Suppurativa (HS) IND Extension of indication to include treatment of Juvenile Idiopathic Arthritis (Enthesitis Related Arthritis and Juvenile Psoriatic Arthritis) in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. IND Extension of indication to include treatment of Juvenile Idiopathic Arthritis (Enthesitis Related Arthritis and Juvenile Psoriatic Arthritis) in patients 2 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. IND Sizavaleucel Spesolimab Sutimlimab Tapinarof Adult Plaque Psoriasis Atopische dermatitis Teduglutide IND Tirbanibulin Tofacitinib IND Tralokinumab IND Upadacitinib Rinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. IND Moderately to Severely Active Crohns disease IND Rinvoq is indicated for the treatment of non radiografic active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy IND Vedolizumab IND Voclosporin Vonoprazan Infectious diseases APN01 Anakinra IND Atazanavir / cobicistat Baloxavir marboxil IND Baricitinib IND Bizalimogene ralaplasmid Bulevirtide Casirivimab / imdevimab IND Casirivimab/imdevimab Ceftobiprole Ceftolozane / tazobactam IND Citric acid / lactic acid / potassium bitartrate IND Clindamycin Dalbavancine IND Delafloxacin IND Doravirine / lamivudine / tenofovirdisoproxil IND Durlobactam / sulbactam Elbasvir / grazoprevir IND Eravacycline Fluticasone propionate Fostemsavir Glecaprevir / pibrentasvir IND Ibrexafungerp IND Lenacapavir Lonafarnib IND Lotilaner Maribavir Molnupiravir Nirsevimab Oteseconazole 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 Raltegravir BS Regdanvimab IND Remdesivir Extension of indication to include adults who do not require invasive mechanical ventilation at start of treatment. • In adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment). IND Treatment of paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) or other non-invasive ventilation at start of treatment IND Treatment of paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 IND Rezafungin SER 109 Sofosbuvir / velpatasvir IND Sofosbuvir / velpatasvir / voxilaprevi IND Sotrovimab Tebipenem Tecovirimat Tixagevimab / cilgavimab The prevention of COVID-19 in adults. Extension of indication to include treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID-19, who do not require supplemental oxygen. IND Tocilizumab IND Lung diseases Ambrisentan IND Benralizumab 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 IND 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). Pirfenidone Pirfenidone AET is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). G Extension of indication to include the treatment of advanced Idiopathic Pulmonary Fibrosis (IPF) for Esbriet. IND Tezepelumab Neurological disorders Aducanumab Aflibercept IND Amifampridine G Arimoclomol IND Atogepant Avacincaptad pegol Bidridistrogene xeboparvovec Brivaracetam IND Brolucizumab IND Bupivacaine extended release IND Buprenorphine IND Bupropion/dextromethorphan Cannabidiol IND Cannabidiol gel/intradermaal Cenobamaat Clazosentan Daridorexant Daxibotulinumtoxine A Deoxythymidine/deoxycytidine Dexmedetomidine Di-deuterated ethyl linoleate Dihydroergotamine Dimethyl fumarate Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS). 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 Eculizumab IND Efgartigimod Eladocagene exuparvovec Eptinezumab Esketamine IND Faricimab Treatment of neovascular (wet) age-related macular degeneration (nAMD). Treatment of visual impairment due to diabetic macular oedema (DME). Fasinumab Fenfluramine IND Ganaxolone Golodirsen Inebilizumab JZP-258 Lacosamide IND Lasmiditan Lenadogene nolparvovec Lidocaïne Lisdexamfetamine IND Lumateperone Melatonine Meloxicam / rizatriptan Molindone Natriumoxybaat controlled release Ofatumumab Pegcetacoplan IND Perfluorohexyloctane Phentolamine Pitolisant Ranibizumab Wet age-related macular degeneration (AMD). BS Wet age-related macular degeneration (AMD). BS Treatment of neovascular age-related macular degeneration (AMD) Ravulizumab IND Remimazolam Reproxalap Rimegepant Risdiplam 5q SMA in patients 2 months of age and older, with a clinical diagnosis of Type 1, Type 2 or Type 3 SMA or with one to four SMN2 copies. Extension of indication to include treatment of patients below 2 months of age. IND Rozanolixizumab SDN037 Satralizumab Sepofarsen Sodium phenylbutyrate/tauroursodeoxycholic acid Sugammadex G 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 Vamorolone Vutrisiran Zilucoplan Zuranolone Cardiovascular diseases Allogenic immunomodulatory progenitor cells Angiotensin II Apabetalon Bempedoic acid Crizanlizumab Dabigatran G Dapagliflozine IND Daprodustat Eculizumab BS Efgartigimod Emicizumab IND Emiplacel Empagliflozine IND Eptacog alfa IND Eptacog alfa (activated) BS Eptacog beta (activated) Etranacogene dezaparvovec Etripamil Evinacumab Evolocumab IND Exagamglogene autotemcel FLT180a Fibrinogen / Thrombin IND Horse anti-human T lymphocyte immunoglobulin Icosapent ethyl Inclisiran Luspatercept IND Macitentan IND Macitentan / tadalafil Mavacamten Mepolizumab IND Mitapivat Omecamtiv mecarbil Pegcetacoplan Proteïne C IND RP-L102 Ravulizumab Behandeling van volwassen en pediatrische patiënten met een lichaamsgewicht van 10 kg of meer met paroxismale nachtelijke hemoglobinurie (PNH): - bij patiënten met hemolyse met klinische symptomen die wijzen op een hoge ziekteactiviteit. - bij patiënten die klinisch stabiel zijn nadat ze ten minste de afgelopen 6 maanden behandeld zijn met eculizumab Extension of Indication to include the treatment of patients with atypical hemolytic uremic syndrome (aHUS). IND Uitbreiding van de behandeling naar pediatrische patiënten met een lichaamsgewicht van 10kg of meer met paroxismale nachtelijke hemoglobinurie (PNH):- bij patiënten met hemolyse met klinische symptomen die wijzen op een hoge ziekteactiviteit.- bij patiënten die klinisch stabiel zijn nadat ze ten minste de afgelopen 6 maanden behandeld zijn met eculizumab. IND Rexlemestrocel-L Rilonacept Sotagliflozine IND Tadalafil IND Tafamidis IND UM171 Udenafil Vadadustat Valoctocogene roxaparvovec Vericiguat Voxelotor Older publications Published on 7 December 2021 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