Gepubliceerd op 7 juni 2022

ADHD

• Lisdexamfetamine

  • Elvanse Adult is geïndiceerd als onderdeel van een uitgebreid behandelingsprogramma voor ADHD bij volwassenen.

• Melatonine

  • Sleep disorders and daily rhythm disorders in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD).
• Molindone

ALL

• Brexucabtagene autoleucel

  • Extension of indication to include treatment of adult patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukaemia (B-ALL) for Tecartus.

• 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.
• Obecabtagene autoleucel

• Ponatinib

  • 1L Philadelphia positieve ALL

ALS

• Arimoclomol

  • Amyotropic Lateral Sclerosis
• Sodium phenylbutyrate/tauroursodeoxycholic acid

AML/MDS

• Azacitidine

  • Onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT).

• Cytarabine / daunorubicin (liposomaal)

  • Extension of indication to add treatment of relapsed/refractory AML in paediatric patients
• Decitabine/cedazuridine
• Eprenetapopt
• Glasdegib
• Imetelstat
• Iomab-B

• 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.

Antitrombotische medicatie

• Dabigatran ^G
• Proteïne C ^IND

• Ravulizumab

  • Extension of Indication to include the treatment of patients with atypical hemolytic uremic syndrome (aHUS).

Astma

• Dupilumab

  • Dupixent is geïndiceerd bij kinderen van 6 tot 11 jaar als add-on onderhoudsbehandeling voor ernstige astma met type 2-ontsteking gekenmerkt door verhoogde eosinofiele in het bloed en/of verhoogde fractie uitgeademde stikstofmonoxide (FeNO), die onvoldoende onder controle zijn met inhalatiecorticosteroïden (ICS) in een gemiddelde tot hoge dosis plus een ander geneesmiddel voor onderhoudsbehandeling.

• Masitinib

  • Patients with severe persistent asthma that is uncontrolled with oral corticosteroids.

• Tezepelumab

  • Severe, inadequately controlled asthma

Baarmoederhalskanker

• Cemiplimab

  • Extension of indication to include monotherapy treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

• Durvalumab

  • Locally advanced cervical cancer

• Lifileucel

  • Treatment of Patients With Cervical Carcinoma (2L)

Bacteriele infecties

• Ceftobiprole
• Ceftolozane / tazobactam ^IND
• Citric acid / lactic acid / potassium bitartrate ^IND
• Clindamycin

• Dalbavancine

  • Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA

• Delafloxacin

  • Extension of indication to include treatment of Community Acquired Pneumonia (CAP) for Quofenix 450mg tablets and 300mg powder for concentrate for solution for infusion.
• Durlobactam / sulbactam

• Eravacycline

  • Xerava is geïndiceerd voor de behandeling van gecompliceerde intra-abdominale infecties (cIAI’s) bij volwassenen.
• SER 109
• Tebipenem

Blaaskanker

• Avelumab

  • 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.

• Durvalumab

  • Neo-adjuvant durvalumab met chemotherapie en adjuvant durvalumab voor behandeling in patiënten met spier invasieve blaaskanker.

• Enfortumab vedotin

  • Padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor‑1 or programmed death‑ligand 1 inhibitor.
• Inbakicept

• Nivolumab

  • 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

Borstkanker

• Abemaciclib

  • Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative, node‑positive early breast cancer at high risk of recurrence. In pre‑ or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
• Amcenestrant
• Balixafortide

• Neratinib

  • Nerlynx is geïndiceerd in combinatie met capecitabine voor patiënten met gemetastaseerde borstkanker met overexpressie van HER2 en progressie na eerdere behandeling met minimaal twee HER-2 gerichte behandelregimes voor gemetastaseerde ziekte.

• Olaparib

  • Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer.

• Paclitaxel

  • Histologically- or cytologically-confirmed breast cancer that is metastatic for whom treatment with IV paclitaxel monotherapy has been recommended by their oncologist.

• Palbociclib

  • Patients with HR+/HER2- invasive early breast cancer in combination with standard adjuvant endocrine therapy.
  • Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery.

• 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.
  • 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.

• Sacituzumab govitecan

  • For adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for advanced disease
• Tesetaxel

• Trastuzumab deruxtecan

  • 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.
  • 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.
  • 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.
• Trastuzumab duocarmazine

• Tucatinib

  • Tucatinib, in combination with trastuzumab and capecitabine, for the treatment of adult patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least two prior anti-HER2 treatment regimens.

Borstvlieskanker

• Nivolumab

  • Opdivo in combination with ipilimumab is indicated for the first line treatment of adult patients with unresectable malignant pleural mesothelioma.

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 the existing CLL indication to include combination treatment with venetoclax for previously untreated patients

• Pirtobrutinib

  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)

• Ublituximab

  • In combination with umbralisib in patients with untreated and previously treated Chronic Lymphocytic Leukemia.

• Zanubrutinib

  • Extension of indication to include treatment of adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic leukaemia (SLL)
  • 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

CML

• Asciminib

  • Philadelphia chromosoom positieve (Ph+) Chronische Myeloïde Leukemie (CML) vanaf derde lijn.

COVID-19

• APN01

• Anakinra

  • COVID-19 in adults with pneumonia requiring supplemental oxygen (low or high flow oxygen) and who are at risk of developing severe respiratory failure, as determined by blood levels of a protein called suPAR (soluble urokinase plasminogen activator receptor) of at least 6 ng per ml.

• Baricitinib

  • Extension of indication to include treatment of coronavirus disease 2019 (Covid 19) in hospitalised adult and paediatric patients aged 10 years and older who require low-flow oxygen or non invasive ventilation/high flow oxygen for Olumiant.

• Casirivimab / imdevimab

  • Extension of indication to include treatment of COVID-19 in hospitalised patients in adults and adolescents aged 12 years and older weighing at least 40 kg for Ronapreve
• Casirivimab/imdevimab
• Molnupiravir
• PF-07321332 / ritonavir
• Regdanvimab ^IND

• Remdesivir

  • 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
  • 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).
• Sotrovimab

• Tixagevimab / cilgavimab

  • 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.
  • The prevention of COVID-19 in adults.

• Tocilizumab

  • Extension of indication to include the treatment of coronavirus disease 2019 in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation for RoActemra.

Chronische immuunziekten, overig

• Adrenaline
• Arachis hypogaea (pinda) allergenen (pleister)
• Avacopan

• Avapritinib

  • Advanced systemic mastocytosis (AdvSM). AYVAKYT is indicated as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL), after at least one systemic therapy.

• Baricitinib

  • Extension of indication to include treatment of severe alopecia areata in adult patients for Olumiant.
  • Systemic lupus erythematosus

• Berotralstat

  • Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
• Budesonide modified released capsule ^IND

• Canakinumab

  • Syndroom van Schnitzler
• Coacillium topical

• Dupilumab

  • 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.
• FCR 001

• Icatibant

  • Acute aanvallen van erfelijk angio-oedeem (HAE) bij volwassenen en kinderen vanaf 2 jaar met C1-esteraseremmerdeficiëntie.
• Mavorixafor
• OTL 103
• RP-L201
• Sizavaleucel
• Sutimlimab
• Voclosporin

• Vonoprazan

  • Patients with Non-Erosive Gastroesophageal Reflux Disease (NERD)

Darmkanker

• Nivolumab

  • 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;
• Tegafur / gimeracil / oteracil ^IND

Darmziekten

• Etrolizumab

  • Moderately to severely active Crohn's disease

• Filgotinib

  • Extension of indication to include the treatment of active ulcerative colitis in adults patients for Jyseleca.

• Mirikizumab

  • Moderate-to-severe active ulcerative colitis (UC) in adults

• Ozanimod

  • Extension of indication to include the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

• Risankizumab

  • Indicated for CD (ziekte van Crohn)

• Teduglutide

  • Extension of indication to include patients from 4 months corrected gestational aged 1 year and above

• Upadacitinib

  • Moderately to Severely Active Crohns disease
  • 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.
• Vedolizumab ^IND

Dementie

• Aducanumab

Depressie

• Bupropion/dextromethorphan

• Esketamine

  • 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.
• Zuranolone

Diabetes

• Bexagliflozine

• Dapagliflozine

  • Extension of indication for Forxiga / Edistride to include treatment of children aged 10 years and adolescents with T2DM based on the results from studies

• Dasiglucagon

  • For the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus type 1.

• Exenatide

  • Extension of indication to include the treatment of type 2 diabetes in adolescents and children aged 10 years and above

• 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
• Insulin lispro ^G
• Polyethylene glycol loxenatide

• Sotagliflozine

  • Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control.
• Teplizumab

• Tirzepatide

  • In combination with monotherapy of oral antihyperglycemic medications or basal insulin in patients with type 2 diabetes mellitus.

Duchenne

• Golodirsen

• Vamorolone

  • Treatment of Duchenne muscular dystrophy.

Eierstokkanker

• Dostarlimab

  • Stage III or IV non mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (collectively referred to as "ovarian cancer")
• Mirvetuximab soravtansine

Epilepsie

• Brivaracetam ^IND

• Cannabidiol

  • Epidyolex is indicated for use as adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC) for patients 2 years of age and older.
• Cenobamaat

• Fenfluramine

  • Extension of indication to include treatment of seizures associated with Lennox-Gastaut syndrome as an add on therapy to other antiepileptic medicines for patients 2 years of age and older.
• Ganaxolone
• Lacosamide ^IND

Fungale infecties

• Ibrexafungerp

  • Patients with acute Vulvovaginal Candidiasis
• Oteseconazole

• Posaconazol

  • 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.
  • 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.
• Rezafungin

HIV

• Atazanavir / cobicistat
• Doravirine / ​lamivudine / ​tenofovirdisoproxil ^IND
• Fostemsavir

• Lenacapavir

  • In Combination With an Optimized Background Regimen in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance Adult aged ≥ 18 years or adolescent aged ≥ 12 and weighing ≥ 35kg.
• Raltegravir ^BS

Hematologie, overig

• Eltrombopag

  • Extension of indication to include treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) irrespective of time since initial diagnosis

• Zanubrutinib

  • 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.

Hemostase bevorderende medicatie

• Emicizumab

  • Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency): mild or moderate disease for whom prophylaxis is clinically indicated.

• Eptacog alfa (activated)

  • Preventie en behandeling van bloedingen bij operaties of invasieve ingrepen bij: 1) overgeërfde hemofilie met remmers tegen stollingsfactor VIII of IX (> 5 BU) of bij een verwachte hoge anamnestische respons op factor VIII of factor IX 2) verworven hemofilie 3) overgeërfde factor VII-deficiëntie 4) ziekte van Glanzmann (trombasthenie) met eerdere of huidige ongevoeligheid voor bloedplaatjestransfusie of wanneer bloedplaatjes niet direct beschikbaar zijn.
• Eptacog beta (activated)
• Etranacogene dezaparvovec
• FLT180a
• Valoctocogene roxaparvovec

Hersenkanker

• Autologous glioma tumor cell lysates

Hoofd- en halskanker

• Pembrolizumab

  • Locally Advanced Head and Neck Squamous Cell Carcinoma With Chemoradiation.

• Tislelizumab

  • 2L ESCC (esophageal squamous-cell carcinoma)

Hoofdpijn

• Atogepant

  • Prevention of Chronic Migraine.
• Dihydroergotamine

• Eptinezumab

  • Vyepti is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.
• Lasmiditan
• Meloxicam / rizatriptan

• Rimegepant

  • VYDURA is indicated for the acute treatment of migraine with or without aura in adults and preventive treatment of episodic migraine in adults who have at least 4 migraine attacks per month.

Huidkanker

• Darleukin fibromun

• Lenvatinib

  • Unresectable Advanced Melanoma (1L) in combination with pembrolizumab.

• Pembrolizumab

  • 1L treatment with pembrolizumab for advanced melanoma, in combination with lenvatinib.
  • 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
• Relatlimab

Huidziekten

• Abrocitinib

  • Cibinqo is geïndiceerd voor de behandeling van matige tot ernstige atopische dermatitis bij volwassenen die in aanmerking komen voor systemische behandeling.
• Beremagene geperpavec
• Berkenschorsextract

• Deucravacitinib

  • Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy
• Difelikefalin

• Dupilumab

  • Dupixent is geïndiceerd bij kinderen van 6 maanden tot 6 jaar met ernstige atopische dermatitis die in aanmerking komen voor systemische behandeling.
  • 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.

• Lebrikizumab

  • Moderate to Severe Atopic Dermatitis in patients aged 12 years and older
• Ligelizumab
• Regenerative Skin Tissue
• Roflumilast topical

• Ruxolitinib phosphate

  • Patients 12 years and older with non-segmental vitiligo with facial involvement

• Secukinumab

  • Hidradenitis Suppurativa (HS)

• Spesolimab

  • Patients with Generalized pustular psoriasis (GPP) who experiencing acute moderate or severe disease flares.

• Tapinarof

  • Adult Plaque Psoriasis
  • Atopische dermatitis
• Tirbanibulin

• Tralokinumab

  • Adtralza is indicated for the treatment of moderate to severe atopic dermatitis in adult patients and adolescents 12 -17 years who are candidates for systemic therapy.

Infectieziekten, overig

• Baloxavir marboxil

  • Influenza Paediatric >1-<12 years (miniSTONE-2) Line extension granule formulation for oral suspension
• Fluticasone propionate

Leverkanker

• Durvalumab

  • Extension of indication to include IMFINZI in combination with tremelimumab for the treatment of adults with unresectable hepatocellular carcinoma (uHCC).
  • Durvalumab (+/- bevacizumab) in combinatie met TACE in patiënten met locoregionale HCC.

• Lenvatinib

  • Advanced Hepatocellular Carcinoma (1L) in combination with pembrolizumab

• Pembrolizumab

  • Advanced Hepatocellular Carcinoma in combination with lenvatinib (1L).

• Pemigatinib

  • Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

• Tremelimumab

  • Extension of indication in combination with durvalumab for the treatment of adults with unresectable hepatocellular carcinoma (uHCC).

Leverziekten

• Maralixibat

  • Treatment of cholestatic liver disease in patients with Alagille syndrome (ALGS) 1 year of age and older.

• Obeticholic acid

  • Fibrosis due to Non-Alcoholic Steatohepatitis (NASH)
• Seladelpar

Lipidenverlagende medicatie

• Bempedoic acid

• Evinacumab

  • Evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (HoFH).

• Evolocumab

  • Extension of indication to include one new paediatric indication in paediatric patients aged 10 years and over with heterozygous and homozygous familial hypercholesterolaemia as an adjunct to diet, in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL‑C goals with the maximum tolerated dose of a statin or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

• Inclisiran

  • Leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non‑familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid‑lowering therapies in patients unable to reach LDL‑C goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid‑lowering therapies in patients who are statin‑intolerant, or for whom a statin is contraindicated.

Longkanker

• Adagrasib

• Amivantamab

  • Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, after failure of platinum-based chemotherapy.

• Atezolizumab

  • 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
  • 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

• Avelumab

  • First-line Treatment of Recurrent or Stage IV PD-L1+ Non-small Cell Lung Cancer.
• Capmatinib

• Cemiplimab

  • 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.
  • 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.

• 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.
  • 1L advanced NSCLC
  • Limited stage small cell lung cancer (LS-SCLC) following concurrent platinum-based chemotherapy and radiation therapy in combination with Tremelimumab.
  • Non-small cell lung cancer (NSCLC) stage IV, in combination with chemo, 1L.
  • Lokaal gevorderd, niet-resectabel NSCLC (stadium III)
  • Completely resected NSCLC
• Ensartinib

• Lenvatinib

  • Advanced or Recurrent Non Small Cell Lung Cancer (1L, non squamous) in combination with pembrolizumab.

• Lorlatinib

  • Extension of indication to include 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.

• Lurbinectedin

  • Small cell lung cancer (SCLC)
• Mobocertinib

• Nivolumab

  • 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).
• OSE-2101

• Osimertinib

  • The adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.

• Pembrolizumab

  • 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.

• Pralsetinib

  • Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer.

• Selpercatinib

  • 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.
• Sintilimab
• Sotorasib
• Tepotinib

• Tislelizumab

  • 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.

• Toripalimab

  • Patients with advanced non-small cell lung cancer without activated EGFR mutation (exon 19 deletion, or exon 21 L858R, exon 21 L861Q, exon 18 G719X or exon 20 S768I mutations) and ALK fusion in combiantion With Chemotherapy.

• Trastuzumab deruxtecan

  • Treatment of adult patients with HER2-mutated, Unresectable and/or Metastatic non-small cell lung cancer (NSCLC).

• Tremelimumab

  • Treatment of adults with metastatic NSCLC with no sensitising epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumour aberrations.
• Trilaciclib

Longziekten, overig

• Ambrisentan

  • Extension application to introduce a new strength (2.5 mg film-coated tablet), grouped with an extension of indication to include treatment of PAH in adolescents and children (8 to less than 18 years).

• Benralizumab

  • Patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids.
• Gefapixant

• Mepolizumab

  • Extension of indication to include Eosinophilic Granulomatosis with Polyangiitis (EGPA) to Nucala
  • Extension of indication to include Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) for Nucala (mepolizumab).

• Pirfenidone

  • Extension of indication to include the treatment of advanced Idiopathic Pulmonary Fibrosis (IPF) for Esbriet.

Maagkanker

• Nivolumab

  • 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.
• Ripretinib

• Trastuzumab deruxtecan

  • 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
• Zolbetuximab

Multipel Myeloom

• Belantamab mafodotin

  • Multiple Myeloma 3L

• Carfilzomib

  • Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

• Ciltacabtagene autoleucel

  • Carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.

• 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).
  • Multipel myeloom frontline behandeling in combinatie met VRd voor patiënten die niet in aanmerking komen voor een ASCT.
  • Smouldering multipel myeloom.
  • Darzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis.
  • 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.
  • 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).

• Elranatamab

  • Triple Class Refractory Multiple Myeloma

• Idecabtagene vicleucel

  • Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

• 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.
  • In Combination With Bortezomib, Lenalidomide and Dexamethasone (Isa VRd) in Patients With Newly Diagnosed Multiple Myeloma (NDMM) Not Eligible for Transplant.

• Ixazomib

  • Non-ASCT maintenance  Multiple Myeloma (MM)

• Melphalan flufenamide

  • In Combination With Dexamethasone in Relapsed Refractory Multiple Myeloma Patients.

• Pomalidomide

  • Extension of indication to include treatment with Imnovid in combination with bortezomib and dexamethasone of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.

• Selinexor

  • 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.
• Teclistimab
• Thalidomide ^G

• Venetoclax

  • Patients With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma
• Zevorcabtagene autoleucel

Multiple sclerose

• Dimethyl fumarate

  • Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).
  • Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).
  • Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
  • Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).
• Diroximel fumarate
• Ofatumumab

• Teriflunomide

  • Aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis.
  • Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).

• Ublituximab

  • Relapsing multiple sclerosis

Myeloproliferatieve aandoeningen

• Momelotinib
• Navitoclax
• Ropeginterferon alfa-2b

Neuro-endocriene kanker

• Selumetinib

  • Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and above. Koselugo should be prescribed by physicians experienced in the diagnosis and the treatment of patients with NF1 related tumours.
• Surufatinib

Neurologie, overig

• Cannabidiol gel/intradermaal
• Clazosentan

• Eculizumab

  • Soliris is indicated in adults for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease.
• Eladocagene exuparvovec

• Inebilizumab

  • Adult patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.
• Remimazolam
• Rozanolixizumab

• Satralizumab

  • Patiënten met neuromyelitis optica‑spectrumstoornissen (NMOSD), die seropositief zijn voor anti-aquaporine-4-IgG (AQP4-IgG) (vanaf 12 jaar).

• Tiratricol

  • Treatment of children and adults with MCT8 deficiency (also called the Allan-Herndon-Dudley syndrome (AHDS))

• Vutrisiran

  • Hereditary transthyretin-mediated amyloidosis.
• Zilucoplan

Nierkanker

• Avelumab

  • Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

• Cabozantinib

  • Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.

• Lenvatinib

  • KISPLYX is indicated for the treatment of adults with advanced renal cell carcinoma (RCC) in combination with pembrolizumab, as first-line treatment.

• Pembrolizumab

  • 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.
  • Extension of indication for Keytruda to include in combination with lenvatinib first line treatment of adults with advanced renal cell carcinoma (RCC).
• Tivozanib ^IND

Non-hodgkin lymfoom agressief

• Axicabtagene ciloleucel

  • Recidiverend of refractair na 1 of meer lijnen van therapie DLBCL, transplant-eligible.

• Crizotinib

  • Extension of indication to include treatment of paediatric patients (age ≥ 6 to < 18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) and with unresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumour (IMT) for XALKORI

• Ibrutinib

  • Mantle cell lymphoma (MCL), 1L.
  • 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

• Lisocabtagene maraleucel

  • Treatment of large B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after at least two previous lines of treatments.

• Loncastuximab tesirine

  • Adult patients with relapsed or refractory large B-cell lymphoma.

• Pirtobrutinib

  • Mantle Cell Lymphoma (MCL)

• Polatuzumab vedotin

  • Polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone, is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma

• Tafasitamab

  • MINJUVI is indicated in combination with lenalidomide followed by MINJUVI monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT)

• Zanubrutinib

  • Mantle-cell lymphoma (1L) + Rituximab.

Non-hodgkin lymfoom indolent

• Axicabtagene ciloleucel

  • Yescarta is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.
• Copanlisib
• Hypericin

• Mosunetuzumab

  • Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.
• Parsaclisib
• Umbralisib

Onbekend

• Axicabtagene ciloleucel

  • 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)

• Dapagliflozine

  • Forxiga is indicated in adults for the treatment of chronic kidney disease.
• Diazoxide choline (controlled-release tablet)

• Empagliflozine

  • Treatment of patients with chronic kidney disease.
• Levonorgestrel ^G

• Linzagolix

  • Yselty is indicated for treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
• Lonapegsomatropin
• Lumasiran
• Mirabegron ^IND
• Olopatadine / mometasone
• Osilodrostat

• Pirfenidone

  • Pirfenidone AET is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).

• Relugolix

  • Patients With Endometriosis-Associated Pain.
• Relugolix / estradiol / norethisteronen

• 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.

• Sirolimus

  • Treatment of angiofibroma associated with tuberous sclerosis complex
• Sofpironium bromide

• Vosoritide

  • Anticipated indication is the treatment of achondroplasia for children.

Oncologie, overig

• Afamitresgene autoleucel

• 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.

• Durvalumab

  • Extension of indication to include IMFINZI in combination with chemotherapy for the treatment of adults with locally advanced or metastatic biliary tract cancer (BTC).
• Efbemalenograstim alfa

• Erdafitinib

  • Adults and paediatric patients with unresectable locally advanced or metastatic solid tumours harbouring susceptible FGFR mutations or fusions, who have progressed on or after at least 1 line of systemic therapy and have no satisfactory alternative treatments (tumor-agnostisch)
• Futibatinib
• Glucarpidase

• Infigratinib

  • Treatment of previously treated cholangiocarcinoma patients harbouring FGFR2 fusions or rearrangements.

• Ivosidenib

  • Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation who were previously treated by at least one prior line of systemic therapy.
• Jodium (131I) omburtamab

• Lenvatinib

  • Advanced or Recurrent Endometrial Cancer (1L) in combination with pembrolizumab.
  • 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
• Lipegfilgrastim ^IND
• NY-ESO-1 autologous engineered TCR-T cells

• Nivolumab

  • 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
  • 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.

• Pembrolizumab

  • 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.
  • 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.
  • 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.
  • 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.

• Selinexor

  • Patients diagnosed with advanced unresectable dedifferentiated liposarcoma.
• Sodium thiosulfate

• Tebentafusp

  • KIMMTRAK is indicated as monotherapy for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Oogaandoeningen

• Aflibercept

  • Retinopathy of prematurity
• Avacincaptad pegol

• Brolucizumab

  • Extension of indication to include treatment of visual impairment due to diabetic macular oedema (DME)

• Faricimab

  • Treatment of neovascular (wet) age-related macular degeneration (nAMD).
  • Treatment of visual impairment due to diabetic macular oedema (DME).
• Lenadogene nolparvovec

• Pegcetacoplan

  • Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
• Perfluorohexyloctane
• Phentolamine

• Ranibizumab

  • Wet age-related macular degeneration (AMD).
  • Wet age-related macular degeneration (AMD).
  • Treatment of neovascular age-related macular degeneration (AMD)

• Reproxalap

  • Moderate to severe dry eye disease
• Sepofarsen
• Timrepigene emparvovec

Overige medicatie hart-en vaatziekten

• Allogenic immunomodulatory progenitor cells
• Angiotensin II
• Apabetalon

• Dapagliflozine

  • Chronic Heart Failure With Preserved Ejection Fraction (HFpEF).
• Emiplacel

• Empagliflozine

  • Chronic Heart Failure With Preserved Ejection Fraction (HFpEF, LVEF >40%).
• Etripamil
• Fibrinogen / Thrombin ^IND
• Icosapent ethyl

• Macitentan

  • Fontan-palliated pulmonary hypertension in adults.
• Macitentan / tadalafil

• Mavacamten

  • Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy
• Omecamtiv mecarbil
• Rexlemestrocel-L

• Rilonacept

  • In paediactric and adult patients with Recurrent Pericarditis ≥12 years

• Sotagliflozine

  • Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure
• Tadalafil ^IND
• Tafamidis ^IND
• Udenafil

• Vericiguat

  • Verquvo is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring IV therapy

Overige niet-oncologische hematologische medicatie

• Crizanlizumab
• Daprodustat

• Eculizumab

  • Paroxysmal nocturnal haemoglobinuria

• Efgartigimod

  • Idiopathic thrombocytopenic purpura (ITP)
• Eptacog alfa ^IND
• Exagamglogene autotemcel
• Horse anti-human T lymphocyte immunoglobulin

• Luspatercept

  • Extension of indication in β-thalassaemia to include adult patients with non-transfusion dependent β-thalassaemia (NTDT).

• Mepolizumab

  • Adolescent and Adult Subjects With Severe Hypereosinophilic Syndrome (HES) refractory to current standard of care.

• Mitapivat

  • Pyruvate kinase deficiency in transfusion-dependent and transfusion-independent adults

• Pegcetacoplan

  • Paroxysmal nocturnal haemoglobinuria (PNH)
• 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
  • 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.

• UM171

  • Patients With Sickle-Cell Disease
• Vadadustat
• Voxelotor

Parasitaire infecties

• Lotilaner

Pijn

• Bupivacaine extended release ^IND

• Buprenorphine

  • Treatment of moderate to severe chronic pain in patients with opioid dependence.
• Fasinumab
• Lidocaïne
• SDN037

Prostaatkanker

• 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.
  • 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.

• 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.

• Degarelix

  • Firmagon is a gonadotrophin releasing hormone (GnRH) antagonist indicated 1) for treatment of high-risk localized and locally advanced hormone-dependent prostate cancer in combination with radiotherapy. 2) as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone-dependent prostate cancer.
• Leuprolide mesylate

• Lutetium (177lu) vipivotide tetraxetan

  • Treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration resistant prostate cancer (mCRPC)

• Masitinib

  • Metastatic Castration-resistant Prostate Cancer
• Niraparib / abiraterone

• Olaparib

  • 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).
  • treatment of adults with metastatic castration resistant prostate cancer (mCRPC), with Lynparza in combination with abiraterone and prednisone or prednisolone

• Pembrolizumab

  • 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).

• Relugolix

  • Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.

Psychiatrie, overig

• Dexmedetomidine

  • Agitation in Schizophrenia, Bipolar Disorder

Reuma

• Anifrolumab

  • Saphnelo is geïndiceerd als aanvullende therapie voor de behandeling van volwassen patiënten met matige tot ernstige, actieve auto-antilichaampositieve systemische lupus erythematosus (SLE), ondanks standaardbehandeling.
• Cyclobenzaprine hydrochloride

• Risankizumab

  • 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).

• Sarilumab

  • Patients aged 2-17 years with Polyarticular Juvenile Idiopathic Arthritis (pJIA)

• Secukinumab

  • 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.
  • 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.

• Tofacitinib

  • Extension of indication for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.

• Upadacitinib

  • Rinvoq is indicated for the treatment of non radiografic active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy

SMA

• Risdiplam

  • Extension of indication to include treatment of patients below 2 months of age.
  • 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.

Schildklierkanker

• Cabozantinib

  • 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

• Pralsetinib

  • 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.

• Selpercatinib

  • 1L treatment of adults and children >12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC).
  • 1L treatment advanced or metastatic RET fusion-positive thyroid cancer (TC)

Schizofrenie, psychose, bipolaire stoornis

• Lumateperone

Slaapstoornissen

• Daridorexant
• JZP-258
• Natriumoxybaat controlled release

• Pitolisant

  • Ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by, or who have not tolerated, OSA primary therapy, such as continuous positive airway pressure (CPAP).

Spierziekten, overig

• Amifampridine ^G
• Bidridistrogene xeboparvovec
• Daxibotulinumtoxine A
• Deoxythymidine/deoxycytidine
• Di-deuterated ethyl linoleate

• Efgartigimod

  • Treatment of generalized Myasthenia Gravis (gMG)

• Ravulizumab

  • Treatment of adult patients with generalized myasthenia gravis (gMG).

• Sugammadex

  • Opheffing van een door rocuronium geïnduceerd neuromusculair blok bij: Volwassenen: voor onmiddellijke opheffing en voor de zogenaamde. 'standaardopheffing'; Kinderen: standaardopheffing.

Stamceltransplantaties

• 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.
• Inolimomab
• Motixafortide
• Omidubicel

• Ruxolitinib

  • Extension of indication to include treatment of patients with GvHD aged 12 years and older who have inadequate response to corticosteroids or other systemic therapies for Jakavi.
• Tabelecleucel

• Tisagenlecleucel-T

  • Extension of indication for Kymriah, to include adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

• Treosulfan

  • Extension of indication to include additional non-malignant transplant indications (non-malignant diseases in the paediatric population)

Stofwisseling en Endocrinologie, overig

• Abaloparatide

  • Treatment of osteoporosis.

• Burosumab

  • Extension of indication to include treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in patients aged 1 year and over.
• Corifollitropin alfa ^IND
• Drospirenon / estetrol, monohydraat
• Ospemifene

• Semaglutide

  • For weight management in people with obesity or who are overweight and have other related conditions.

• Setmelanotide

  • Treatment of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS).

Stofwisselingsziekten

• Arimoclomol

  • Treatment of Niemann-Pick disease type C (NPC).
• 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

  • Barth syndrome
• Fexapotide
• Fezolinetant
• Fosdenopterin

• Hydrocortison

  • Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.
• Leriglitazone
• Levoketoconazole

• Liraglutide

  • Extension of indication to include treatment as an adjunct to a healthy nutrition and physical activity counselling for weight management in adolescent patients from the age of 12 years and above with body weight above 60kg and obesity (BMI corresponding to ≥30kg/m2 for adults).

• Lonafarnib

  • Zokinvy is indicated for the treatment of patients 12 months of age and older with a genetically confirmed diagnosis of Hutchinson-Gilford progeria syndrome or a processing-deficient progeroid laminopathy associated with either a heterozygous LMNA mutation with progerin-like protein accumulation or a homozygous or compound heterozygous ZMPSTE24 mutation.

• Migalastat

  • Galafold is indicated for long-term treatment of adults and adolescents aged 12-16 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation.

• Octreotide

  • Acromegalie
• Olenasufligene relduparvovec
• Olipudase alfa
• Palovarotene
• Pegunigalsidase alfa
• Reloxaliase
• Sapropterin ^G

• Somatrogon

  • Ngenla is geïndiceerd voor de behandeling van kinderen en adolescenten vanaf 3 jaar met een groeistoornis als gevolg van onvoldoende secretie van groeihormoon

• Sparsentan

  • Focal Segmental Glomerulosclerosis

Taaislijmziekte

• 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

  • Kalydeco tablets are indicated in a combination regimen with ivacaftor /tezacaftor /elexacaftor tablets for the treatment of adults, and adolescents and children aged 6 years and older with cystic fibrosis (CF) who have at least one F508del mutation in the CFTR gene

Virale infecties, overig

• Bizalimogene ralaplasmid

• Bulevirtide

  • Hepcludex is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult patients with compensated liver disease.
• Elbasvir / grazoprevir ^IND

• Glecaprevir / pibrentasvir

  • Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and in adolescents children aged 3 years and older.

• Lonafarnib

  • Hepatitis D infection with ritonavir
• Maribavir

• Nirsevimab

  • Respiratory syncytial virus infection prevention in Immunocompromised newborns and infants ≤ 24 months.

• Remdesivir

  • 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
• Sofosbuvir / velpatasvir ^IND
• Sofosbuvir / velpatasvir / voxilaprevi ^IND
• Tecovirimat