ADHD Lisdexamfetamine IND Molindone ALL Blinatumomab Blincyto is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. IND Extension of indication to include the use of blinatumomab as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor ALL as consolidation therapy 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 AML / MDS Arseentrioxide Geïndiceerd voor het induceren van remissie en consolidatie bij volwassen patiënten met: 1) nieuw gediagnosticeerde acute promyelocytaire leukemie (APL) met laag tot middelmatig risico (aantal witte bloedcellen ≤ 10 x 103/μl) in combinatie met all-trans-retinoïnezuur (ATRA), 2) recidiverende/refractaire acute promyelocytaire leukemie (APL) (tijdens een eerdere behandeling moet een retinoïde stof zijn toegediend en chemotherapie hebben plaatsgehad), gekenmerkt door de aanwezigheid van de translocatie t(15;17) en/of de aanwezigheid van het gen promyeolocitaire-leukemie-/retinoïnezuurreceptor-alfa (PML/RAR-alfa). G Geïndiceerd voor het induceren van remissie en consolidatie bij volwassen patiënten met: 1) nieuw gediagnosticeerde acute promyelocytaire leukemie (APL) met laag tot middelmatig risico (aantal witte bloedcellen ≤ 10 x 103/μl) in combinatie met all-trans-retinoïnezuur (ATRA), 2) recidiverende/refractaire acute promyelocytaire leukemie (APL) (tijdens een eerdere behandeling moet een retinoïde stof zijn toegediend en chemotherapie hebben plaatsgehad), gekenmerkt door de aanwezigheid van de translocatie t(15;17) en/of de aanwezigheid van het gen promyeolocitaire-leukemie-/retinoïnezuurreceptor-alfa (PML/RAR-alfa). G Geïndiceerd voor het induceren van remissie en consolidatie bij volwassen patiënten met: 1) nieuw gediagnosticeerde acute promyelocytaire leukemie (APL) met laag tot middelmatig risico (aantal witte bloedcellen ≤ 10 x 103/μl) in combinatie met all-trans-retinoïnezuur (ATRA), 2) recidiverende/refractaire acute promyelocytaire leukemie (APL) (tijdens een eerdere behandeling moet een retinoïde stof zijn toegediend en chemotherapie hebben plaatsgehad), gekenmerkt door de aanwezigheid van de translocatie t(15;17) en/of de aanwezigheid van het gen promyeolocitaire-leukemie-/retinoïnezuurreceptor-alfa (PML/RAR-alfa). G Azacitidine AML post-intensive chemotherapy maintenance therapy for patients in complete remission Geïndiceerd voor de behandeling van volwassen patiënten die niet in aanmerking komen voor hematopoëtische stamceltransplantatie (HSCT), met: • intermediair 2 en hoog risico myelodysplastische syndromen (MDS) volgens het International Prognostic Scoring System (IPSS), • chronische myelomonocytaire leukemie (CMML) met 10%-29% beenmergblasten zonder myeloproliferatieve aandoening, • acute myeloïde leukemie (AML) met 20%-30% blasten en multilineaire dysplasie, volgens de indeling van de Wereldgezondheidsorganisatie (WHO). • AML met >30% beenmergblasten volgens de indeling van de WHO. G Geïndiceerd voor de behandeling van volwassen patiënten die niet in aanmerking komen voor hematopoëtische stamceltransplantatie (HSCT), met: • intermediair 2 en hoog risico myelodysplastische syndromen (MDS) volgens het International Prognostic Scoring System (IPSS), • chronische myelomonocytaire leukemie (CMML) met 10%-29% beenmergblasten zonder myeloproliferatieve aandoening, • acute myeloïde leukemie (AML) met 20%-30% blasten en multilineaire dysplasie, volgens de indeling van de Wereldgezondheidsorganisatie (WHO). • AML met >30% beenmergblasten volgens de indeling van de WHO. G Geïndiceerd voor de behandeling van volwassen patiënten die niet in aanmerking komen voor hematopoëtische stamceltransplantatie (HSCT), met: • intermediair 2 en hoog risico myelodysplastische syndromen (MDS) volgens het International Prognostic Scoring System (IPSS), • chronische myelomonocytaire leukemie (CMML) met 10%-29% beenmergblasten zonder myeloproliferatieve aandoening, • acute myeloïde leukemie (AML) met 20%-30% blasten en multilineaire dysplasie, volgens de indeling van de Wereldgezondheidsorganisatie (WHO). • AML met >30% beenmergblasten volgens de indeling van de WHO. G Gilteritinib Glasdegib Guadecitabine Idasanutlin Imetelstat Iomab-B Ivosidenib Relapsed or refractory isocitrate dehydrogenase-1 (IDH-1) mutation-positive acute myeloid leukaemia Acute myeloid leukaemia (AML), isocitrate dehydrogenase-1 (IDH1) mutation - first-line combination therapy. IND Luspatercept Sapacitabine Venetoclax IND Aggressive non-Hodgkin's lymphoma Brentuximab vedotin IND Lisocabtagene maraleucel Polatuzumab vedotin Rituximab IND Tafasitamab Tagraxofusp Zanubrutinib Allergy Arachis hypogaea (pinda) allergenen (capsule) Arachis hypogaea (pinda) allergenen (pleister) Olopatadine / mometasone Omalizumab IND Antithrombotic medications Apixaban G Dabigatran G Dabigatran etexilate IND Ravulizumab IND Rivaroxaban IND Asthma Beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium IND Budesonide / formoterol IND Fluticasone furoate / umeclidinium / vilanterol IND Indacaterol acetate/glycopyrronium bromide/mometasone furoate Indacaterol acetate/mometasone furoate Masitinib IND Omalizumab Aanvullende behandeling om de astmacontrole te verbeteren bij patiënten met ernstig persistent allergisch astma. BS Aanvullende behandeling om de astmacontrole te verbeteren bij patiënten met ernstig persistent allergisch astma. BS Aanvullende behandeling om de astmacontrole te verbeteren bij patiënten met ernstig persistent allergisch astma. Ook voor de behandeling van chronische idiopathische urticaria. BS Bacterial infections Amoxicilline / omeprazol / rifabutin Cefiderocol Ceftaroline fosamil Indicatie uitbreiding voor de behandeling van kinderen jonger dan twee maanden voor gecompliceerde infecties van de huid en van de weke delen (Complicated Skin and Soft Tissue Infection, cSSTI) en buiten het ziekenhuis opgelopen pneumonie (Community-acquired pneumonia, CAP). IND Extension of indication for the treatment of community acquired pneumonia (CAP) to include concurrent bacteraemia due to Streptococcus pneumoniae (SP) for all age groups. IND Ceftazidime / avibactam Zavicefta is indicated in adults and children aged 3 months and older and adolescents for the treatment of the following infections in adults with Complicated intra-abdominal infection (cIAI), Complicated urinary tract infection (cUTI), including pyelonephritis, Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). IND Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, the currently approved indications for complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI) and hospital-acquired pneumonia, including ventilator-associated pneumonia. IND Ceftolozaan / tazobactam IND Delafloxacin Quofenix is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Extension of indication to include treatment of Community Acquired Pneumonia (CAP) for Quofenix 450 mg tablets and 300 mg powder for concentrate for solution for infusion. IND Delamanid IND Iclaprim Imipenem / cilastatin / relebactam Recarbrio is indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults. Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults. IND Lefamulin Liposomaal amikacine Obiltoxaximab Ozenoxacine Plazomicin Pretomanid Tedizolid Hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), complex bacterial infections, caused by gram positive pathogens IND Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and adolescents 12 years of age and older. IND Tigecycline G Bipolar disorder Lumateperone Lurasidone IND Bladder cancer Atezolizumab Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC), after prior platinum containing chemotherapy, or who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5%. IND Adjuvant treatment after surgical resection of high-risk muscle-invasive bladder cancer (MIBC). IND Avelumab IND Durvalumab IND Enfortumab vedotin Oportuzumab monatox Pembrolizumab IND Ramucirumab IND Tremelimumab IND Bowel diseases Adalimumab IND Alicaforsen Pouchitis Ulcerative colitis Filgotinib Remestemcel-L IND Tenapanor Upadacitinib IND Brain cancer Asunercept Autologous glioma tumor cell lysates Brain cancer vaccine Tasadenoturev Vocimagene amiretrorepvec Breast cancer Abemaciclib IND Alpelisib Atezolizumab Neoadjuvant treatment for patients with early TNBC in combination with nab-paclitaxel. IND Treatment of patients with previously untreated metastatic TNBC in combination with paclitaxel. IND Margetuximab Neratinib IND Olaparib 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 Breast cancer, metastatic, triple negative, 1L. IND Tripple Negative Breast Cancer - Neoadjuvant and adjuvant. IND Pertuzumab / trastuzumab Sacituzumab govitecan Trastuzumab deruxtecan Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 therapies. Patients with HER2 low, unresectable, and/or metastatic breast cancer previously treated with 1-2 prior lines of chemotherapy 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 Trastuzumab emtansine Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy. IND Trastuzumab entansine in combination with pertuzumab following anthracyclines as adjuvant therapy in patients with operable HER2-positive primary breast cancer. IND Tucatinib Veliparib 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 Venetoclax IND ibrutinib IND COPD Formoterol / glycopyronium / budesonide Revefenacin Cardiovascular diseases Avacopan Sutimlimab Colon cancer Eflornithine / sulindac Encorafenib IND Tegafur / gimeracil / oteraci IND Cystic fibrosis Bamocaftor / tezacaftor / ivacaftor Elexacaftor / tezacaftor / ivacaftor Extension of indication to extend the indication of Kalydeco (ivacaftor) tablets in combination regimen with Kaftrio (ivacaftor/tezacaftor/elexacaftor) tablets for the treatment of adults and adolescents aged 12 years and older with cystic fibrosis (CF) who have at least one F508del mutation in the CFTR gene An Extension of indication for Sarclisa to add combination with carfilzomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. IND Ivacaftor Kalydeco tablets are indicated for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R . IND Extension of indication to extend the indication of Kalydeco (ivacaftor) tablets in combination regimen with Kaftrio (ivacaftor/tezacaftor/elexacaftor) tablets for the treatment of adults and adolescents aged 12 years and older with cystic fibrosis (CF) who have at least one F508del mutation in the CFTR gene. IND Kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R IND Tezacaftor / ivacaftor Symkevi is indicated in a combination regimen with ivacaftor 150 mg tablets for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T. Symkevi is indicated in a combination regimen with ivacaftor 150 mg tablets for the treatment of patients with cystic fibrosis (CF) aged 6 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272‑26A→G, and 3849+10kbC→T. IND Dementia Aducanumab Leuco-methylthioninium Alzheimer’s disease, mild-to-moderate. Dementia, behavioural variant frontotemporal. Depression Brexanolone 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 for the rapid reduction of depressive symptoms in adult patients with a moderate to severe depressive episode of MDD who have current suicidal ideation with intent. IND Zuranolone Diabetes Canagliflozine IND Canagliflozine / metformine IND Dapagliflozin / saxagliptin / metformin Dapagliflozine Extension of Indication to include type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy. IND Patients With Type 2 Diabetes Mellitus Aged 10 to Below 18 Years Old IND Dasiglucagon Empagliflozine IND Exenatide Finerenone Glucagon Insulin aspart The treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. BS The treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. BS Insulin lispro (ultra rapid formulation) Polyethylene glycol loxenatide Reparixin Semaglutide Sotagliflozine Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy. Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control IND Teplizumab Tirzepatide Duchenne Edasalonexent Idebenone Treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) NOT using glucocorticoids. Respiratory dysfunction is defined when PEF%p or FVC%p fall below 80% of the predicted value Treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) using glucocorticoids. Respiratory dysfunction is defined when PEF%p or FVC%p fall below 80% of the predicted value IND Epilepsy Cannabidiol Indicated for use as adjunctive therapy of seizures associated with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older. Extension of indication for use as adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC) for patients 1 year of age and older. 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 Perampanel IND Eye disorders Abicipar Aflibercept BS Aganirsen Brolucizumab IND Faricimab Latanoprostene bunod Lenadogene nolparvovec Lifitegrast Netarsudil / latanoprost Polihexanide 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 Tivanisiran Voretigene neparvovec Head and neck cancer Afatinib IND Brilacidin Durvalumab Squamous cell carcinoma of the head and neck, 1L PDL 1 in combination with tremelimumab IND Squamous cell carcinoma of the head and neck, 1L PDL 1. IND Leukocyte interleukin Pembrolizumab IND Headache Eptinezumab Erenumab Fremanezumab Galcanezumab Lasmiditan Hearing disorders Brimapitide Pioglitazone Hemostasis promoting medication Emicizumab IND Eptacog beta (activated) Etranacogene dezaparvovec Fibrinogen Fidanacogene elaparvovec Valoctocogene roxaparvovec Hodgkin's lymphoma Pembrolizumab IND Hormonal disorders Levoketoconazole Linzagolix Lonapegsomatropin Macimorelin Octreotide Osilodrostat Relugolix Patients With Endometriosis-Associated Pain IND Treatment of uterine fibroids. Somapacitan Somatrogon Tenapanor IND Indolent non-Hodgkin's lymphoma Axicabtagene ciloleucel IND Copanlisib Ibrutinib Follicular lymphoma (FL), relapsed / refractory. IND Marginal zone lymphoma (MZL), relapsed / refractory. IND Umbralisib Kidney cancer Avelumab IND Cabozantinib IND Ipilimumab IND Pembrolizumab Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy. IND Advanced Renal Cell Carcinoma (1L) in combination with lenvatinib. IND Tivozanib IND Leukemia Asciminib Lipid-lowering medications Bempedoic acid Bempedoic acid / ezetimibe Evinacumab Inclisiran Volanesorsen Liver cancer Atezolizumab IND Pembrolizumab IND Pemigatinib Liver diseases Givosiran Maralixibat Obeticholic acid IND Odevixibat Seladelpar Lung cancer Amivantimab Atezolizumab For the 1L treatment of patients with metastatic, squamous NSCLC in combination with chemotherapy. IND Extension of indication to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours express PD-L1. IND Avelumab IND Brigatinib Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. IND Geïndiceerd voor gebruik als monotherapie voor de behandeling van volwassen patiënten met ALK‑positief (anaplastisch lymfoom kinase) gevorderd niet‑kleincellig longcarcinoom (NSCLC) die eerder zijn behandeld met alectinib. IND Canakinumab IND Cemiplimab IND Dacomitinib Durvalumab Non-small cell lung cancer (NSCLC) stage IV, in combination with tremelimumab and chemo,1L. 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 Entrectinib Lurbinectedin Mobocertinib Nivolumab Extension of Indication to include first-line treatment of adult patients with metastatic Non-Small Cell Lung Carcinoma (NSCLC) in combination with ipilimumab and two cycles of 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 Osimertinib IND Pembrolizumab Extension of Indication to include 1st line treatment of locally advanced or metastatic non-small cell lung cancer tumours expressing PD-L1 with a ≥ 1% tumour proportion score (TPS). IND Pembrolizumab in Combination with Etoposide/Platinum (Cisplatin or Carboplatin) for the treatmen of extensive stage Small Cell Lung Cancer (SCLC) (1L). IND Pralsetinib Selpercatinib Sotorasib Tepotinib Trilaciclib Mesothelioma Nivolumab IND Metabolic diseases Arimoclomol citraat 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 Burosumab IND Chenodeoxycholzuur Elivaldogene autotemcel Hydrocortisone Kaliumcitraat / kaliumwaterstofcarbonaat Lonafarnib Nitisinone IND Olipudase alfa Pegvaliase Reloxaliase Trientine Vestronidase alfa Veverimer Volanesorsen IND Multiple Myeloma Belantamab mafodotin Carfilzomib IND 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 Amyloidose eerstelijnsbehandeling in combinatie met bortezomib, cyclofosfamide en dexamethason. IND In combinatie met pomalidomide en dexamethason voor patiënten met multipel myeloom die tenminste een eerdere lijn van behandeling hebben gehad. IND Subcutaneous formulation indicates for Relapsed or Refractory Multiple Myeloma. IND Multipel myeloom frontline behandeling i.c.m. VRd voor patiënten die niet in aanmerking komen voor een ASCT. IND Multipel myeloom frontline behandeling in combinatie met VRd voor patiënten die in aanmerking komen voor een ASCT. IND Multipel myeloom frontline onderhoudsbehandeling na DVTd, voor patiënten die in aanmerking komen voor een ASCT. IND Smouldering multipel myeloom. IND Ibrutinib IND Idecabtagene vicleucel Isatuximab Sarclisa is indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) and have demonstrated disease progression on the last therapy. Combinatie van isatuximab met carfilzomib en dexamethason bij patiënten met gerecidiveerd en refractair multipel myeloom na 1 tot maximaal 3 eerdere behandellijnen. IND JNJ-4528 Lenalidomide IND Pomalidomide IND Selinexor Zanubrutinib Multiple sclerosis Fampridine G Fingolimod G Masitinib Natalizumab Ofatumumab Ozanimod Ponesimod Siponimod Teriflunomide IND Muscular diseases Sugammadex G Myeloproliferative disorders Fedratinib Ropeginterferon alfa-2b Neuroendocrine cancer Selumetinib Surufatinib Other chronic immune diseases Anakinra IND Belatacept IND Belimumab IND Berotralstat Elobixibat Emapalumab Forigerimod Icatibant G Imlifidase Lanadelumab Naldemedine RP-L201 Teprasiran Teprotumumab Triamcinolone Voclosporin Other hematology Carmustine G Other infectious diseases Anidulafungin IND Ibrexafungerp IND Posaconazol Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults: - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Posaconazole Accord is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. G Posaconazole AHCL is indicated for treatment of the following fungal infections in adults: - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. - Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Posaconazole AHCL is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. G Extension of indication to include treatment of invasive aspergillosis in adults IND Rezafungin Other lung Ambrisentan G 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 Molgramostim Nintedanib Ofev is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease. IND Ofev is indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases with a progressive phenotype. IND Omalizumab IND Sarizotan Other medication for cardiovascular diseases Allogenic immunomodulatory progenitor cells Angiotensin II Apabetalon Dapagliflozine Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. IND Chronic Heart Failure With Preserved Ejection Fraction (HFpEF) IND Emiplacel Empagliflozine Chronic Heart Failure With Preserved Ejection Fraction (HFpEF). IND Extension of indication to include treatment of adult patients with heart failure and reduced ejection fraction for Jardiance IND Icosapent ethyl Regadenoson IND Tafamidis IND Ticagrelor Extension of indication to include, in co administration with acetylsalicylic acid (ASA), the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) without a history of myocardial infarction who have undergone percutaneous coronary intervention (PCI). IND Extension of indication to include, in co-administration with acetylsalicylic acid (ASA), the prevention of stroke in adult patients with acute ischaemic stroke or transient ischaemic attack (TIA) in the previous 24 hours. IND Treprostinil Udenafil Valsartan / sacubitril IND Vericiguat Other metabolism and Endocrinology Autologous human chondrocytes in vitro expanded Dapagliflozine IND Elamipretide Fexapotide Liraglutide IND Lumasiran Nolasiban Romosozumab Semaglutide IND Setmelanotide IND Vosoritide Other muscular diseases AMDC-USR Mexiletine HCl Other neurological disorders Buprenorphine Eculizumab IND Eladocagene exuparvovec Inebilizumab Remimazolam Ronopterin Satralizumab 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 Deferasirox Geïndiceerd voor de behandeling van: 1) chronische ijzerstapeling als gevolg van veelvuldige bloedtransfusies bij patiënten van 6 jaar en ouder met bètathalassemie major. 2) chronische ijzerstapeling als gevolg van bloedtransfusies wanneer deferoxamine behandeling gecontra-indiceerd of inadequaat is in de volgende patiëntengroepen: pediatrische patiënten met bètathalassemie major met ijzerstapeling als gevolg van veelvuldige bloedtransfusies in de leeftijd van 2 tot 5 jaar, volwassen en pediatrische patiënten met bètathalassemie major met ijzerstapeling als gevolg van occasionele bloedtransfusies (<7 ml/kg/maand rode bloedcellen) in de leeftijd van 2 jaar en ouder en volwassen en pediatrische patiënten met andere anemieën in de leeftijd van 2 jaar en ouder. 3) chronische ijzerstapeling waarbij chelatietherapie noodzakelijk is en wanneer deferoxaminebehandeling gecontra-indiceerd of inadequaat is bij patiënten in de leeftijd van 10 jaar en ouder met niet-transfusie-afhankelijke thalassemiesyndromen. G Geïndiceerd voor de behandeling van: 1) chronische ijzerstapeling als gevolg van veelvuldige bloedtransfusies bij patiënten van 6 jaar en ouder met bètathalassemie major. 2) chronische ijzerstapeling als gevolg van bloedtransfusies wanneer deferoxamine behandeling gecontra-indiceerd of inadequaat is in de volgende patiëntengroepen: pediatrische patiënten met bètathalassemie major met ijzerstapeling als gevolg van veelvuldige bloedtransfusies in de leeftijd van 2 tot 5 jaar, volwassen en pediatrische patiënten met bètathalassemie major met ijzerstapeling als gevolg van occasionele bloedtransfusies (<7 ml/kg/maand rode bloedcellen) in de leeftijd van 2 jaar en ouder en volwassen en pediatrische patiënten met andere anemieën in de leeftijd van 2 jaar en ouder. 3) chronische ijzerstapeling waarbij chelatietherapie noodzakelijk is en wanneer deferoxaminebehandeling gecontra-indiceerd of inadequaat is bij patiënten in de leeftijd van 10 jaar en ouder met niet-transfusie-afhankelijke thalassemiesyndromen. G Eculizumab Paroxysmal nocturnal haemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) BS Paroxysmal nocturnal haemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) BS Paroxysmal nocturnal haemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). BS Ferumoxytol Hydroxycarbamide Geïndiceerd voor de preventie van recidiverende, pijnlijke vaso-occlusieve crises waaronder het 'acute chest syndrome' bij volwassenen, adolescenten en kinderen ouder dan 2 jaar met symptomatische sikkelcelziekte. G Extension of indication to include treatment of severe chronic anemia (haemoglobin level < 6 g/dL or < 7 g/dL with poor clinical or functional tolerance) in adults, adolescents and children older than 2 years suffering from sickle cell syndrome. IND Luspatercept Mepolizumab IND Pegcetacoplan RP-L102 Ravulizumab Romiplostim IND Roxadustat Thrombomodulin alfa Vadadustat Voxelotor Other oncology 131I-omburtamab Dostarlimab Entrectinib Glucarpidase Ivosidenib IND Larotrectinib Lipegfilgrastim IND Nivolumab IND Pembrolizumab Extension of indication to include first-line treatment of unresectable or metastatic microsatellite instability-high (MSI H) or mismatch repair deficient (dMMR) colorectal cancer in adults for Keytruda. IND Advanced Endometrial Cancer (2L+) in combination with lenvatinib. IND Locally advanced or metastatic esophageal carcinoma (1L) IND Women With Persistent, Recurrent, or Metastatic Cervical Cancer (1L). IND Pexidartinib Sodium thiosulfate Other viral infections APN01 Atazanavir / cobicistat Baloxavir marboxil Bulevirtide Cabotegravir Dapagliflozine IND Dexamethasone IND Etravirine IND Fostemsavir Glecaprevir / pibrentasvir IND Human normal immunoglobulin IND Ibalizumab Maribavir Remdesivir Tecovirimat Zanamivir Ovarian cancer Atezolizumab IND Niraparib IND Olaparib IND Veliparib Pain Bupivacaine Bupivacaine / meloxicam Lidocaïne Neridronic Acid Tanezumab Treatment of moderate to severe chronic pain associated with OA of the hip or knee in adult patients for whom treatment with NSAIDs and/or any opioid is ineffective, not tolerated or inappropriate Chronic Low Back Pain for ≥3 months IND Pancreatic cancer Eryaspase (Asparaginase) Olaparib IND Parkinson's Amantadine Apomorphine Istradefylline Levodopa / carbidopa Pimavanserin 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 voorwie behandeling met chemotherapie nog niet klinisch geïndiceerd is ; - de behandeling van mCRPC bij volwassen mannen bij wie de ziekte progressief was tijdens of na een chemotherapieschema op basis van docetaxel. G Geïndiceerd met prednison of prednisolon voor: - de behandeling van nieuw gediagnosticeerde hoog-risico gemetastaseerde hormoongevoelige prostaatkanker (mHSPC) bij volwassen mannen, in combinatie met androgeendeprivatietherapie (ADT); - de behandeling van gemetastaseerde castratieresistente prostaatkanker (mCRPC) bij volwassen mannen die asymptomatisch of licht symptomatisch zijn na falen van androgeendeprivatietherapie en voor wie behandeling met chemotherapie nog niet klinisch geïndiceerd is ; - de behandeling van mCRPC bij volwassen mannen bij wie de ziekte progressief was tijdens of na een chemotherapieschema op basis van docetaxel. G Abiraterone / apalutamide Apalutamide IND Cabazitaxel 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 Enzalutamide Adult men with metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy. IND De behandeling van volwassen mannen met niet-gemetastaseerd hoog risico-CRPC (castratieresistent prostaatcarcinoom). IND Niraparib IND Olaparib IND Relugolix Rheumatism Anifrolumab Filgotinib Guselkumab IND Ixekizumab IND Olokizumab Secukinumab IND Tocilizumab BS Tofacitinib Treatment of active polyarticular course juvenile idiopathic arthritis patients 2 years of age and older. IND Ankylosing Spondylitis IND Upadacitinib Extension of indication to include the treatment of active ankylosing spondylitis in adult patient for Rinvoq IND RINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who haveresponded inadequately to, or who are intolerant to one or more DMARD. RINVOQ may be used as monotherapy or in combination with nonbiologic DMARDs. IND Ustekinumab IND SMA Onasemnogene abeparvovec Risdiplam Schizophrenia, psychosis Lurasidone IND Olanzapine / samidorphan Skin cancer Atezolizumab IND Cemiplimab Monotherapy treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. Libtayo wordt onderzocht in patiënten met gevorderd basaalcelcarcinoom van de huid (cBCC) die progressie vertonen onder behandeling met hedgehog inhibitor therapie of intolerant waren voor eerdere behandeling met hedgehog inhibitor therapie. IND Dabrafenib / Trametinib IND Darleukin fibromun Lifileucel Relatlimab Seviprotimut-L Spartalizumab Tavokinogene telseplasmid Skin diseases Abrocitinib Baricitinib IND Beremagene geperpavec Berkenschorsextract IND Bimekizumab Clascoterone Crisaborole Difelikefalin Dupilumab IND Glycopyrronium tosylate Ixekizumab IND Lebrikizumab Nemolizumab Secukinumab IND Tapinarof Adult Plaque Psoriasis Atopische dermatitis Tirbanibulin Tralokinumab Trifarotene Upadacitinib IND Sleep disorders JZP-258 Lemborexant Natriumoxybaat IND Solriamfetol Tasimelteon IND Stem cell transplants Axicabtagene ciloleucel IND BL-8040 Ibrutinib IND Inolimomab Itacitinib Narsoplimab Omidubicel Remestemcel-L Rimiducid Rivogenlecleucel Ruxolitinib IND Tabelecleucel Thiotepa G autologous anti-CD19-transduced CD3+ cells Stomach cancer Avapritinib Masitinib Ripretinib Rivoceranib Trastuzumab deruxtecan IND Thyroid cancer 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 Vibegron