Gepubliceerd op 7 december 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

• ARI-0001

• Brexucabtagene autoleucel

  • Tecartus is indicated for the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
• Crisantaspase
• Obecabtagene autoleucel

• Ponatinib

  • Extension of indication to include treatment of newly diagnosed adult patients with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL), either with Iclusig (ponatinib) in combination with chemotherapy, or with Iclusig (ponatinib) monotherapy after corticosteroid induction in patients not eligible to receive chemotherapybased regimens.

ALS

• Arimoclomol

  • Amyotropic Lateral Sclerosis

• Masitinib

  • Amyotrophic lateral sclerosis (ALS), add on in patients on a stable dose of riluzole.
• Sodium phenylbutyrate / tauroursodeoxycholic acid

AML/MDS

• Cytarabine / daunorubicin (liposomaal)

  • Extension of indication to add treatment of relapsed/refractory AML in paediatric patients

• Decitabine / cedazuridine

  • Treatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.
• Eprenetapopt
• Glasdegib
• Imetelstat

• Ivosidenib

  • In combination with azacitidine, in adults with previously untreated IDH1-mutated acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy (≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy).

• Quizartinib

  • Quizartinib is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FMS-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) positive

Antitrombotische medicatie

• Dabigatran ^G
• Proteïne C ^IND

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

  • Add-on treatment in adult and adolescent patients with severe asthma

Baarmoederhalskanker

• Cemiplimab

  • LIBTAYO as monotherapy is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

• 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
• Durlobactam / sulbactam

• Eravacycline

  • Xerava is geïndiceerd voor de behandeling van gecompliceerde intra-abdominale infecties (cIAI’s) bij volwassenen.
• Oritavancin diphosphate ^IND
• 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.

• Erdafitinib

  • Patients with locally advanced and unresectable or metastatic urothelial carcinoma who have progressed on or after 1 or 2 prior treatments with prespecified (FGFR) gene aberrations (FGFR+ blaaskanker)
• 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.
• Balixafortide
• Elacestrant

• Neratinib

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

• Olaparib

  • monotherapie of in combinatie met endocriene therapie voor de adjuvante behandeling van volwassen patiënten met kiembaan-BRCA1/2-mutaties die HER2-negatieve, hoog-risico borstkanker in een vroeg stadium hebben en eerder behandeld zijn met neoadjuvante of adjuvante chemotherapie.

• Paclitaxel

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

• Palbociclib

  • Treatment for patients diagnosed with HR+/HER2+ metastatic breast cancer.

• Pembrolizumab

  • 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

  • Eerder behandelde HR+/HER2- gemetastaseerde borstkanker
  • 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

  • Extension of indication to include treatment of unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or withing 6 months of completing adjuvant chemotherapy. Patients with hormone receptor positive (HR+) breast cancer must additionally have received or be ineligible for 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.

CLL

• Acalabrutinib

  • Extension of the existing CLL indication to include combination treatment with venetoclax for previously untreated patients.
  • Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

• Ibrutinib

  • Imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)

• 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).
  • 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

  • Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome‑positive chronic myeloid leukaemia in chronic phase (Ph+ CML‑CP) previously treated with two or more tyrosine kinase inhibitors.

COPD

• Ensifentrine

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
  • Treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. Prevention of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg .
• Molnupiravir
• PF-07321332 / ritonavir

• Remdesivir

  • Treatment of paediatric patients (weighing at least 40kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19
  • 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

• Tixagevimab / cilgavimab

  • Evusheld is indicated for the treatment of adults and adolescents (aged 12 years and older weighing at least 40kg) with COVID‑19, who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID‑19.
  • Pre-expositie profylaxe van COVID-19 bij volwassenen en adolescenten van 12 jaar en ouder met een lichaamsgewicht van tenminste 40 kilo

Chronische immuunziekten, overig

• 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.
  • Non-advanced systemic mastocytosis

• 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

• 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

• Leniolisib

  • Treatment for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency, in adolescents and adults 12 years or older.
• Marnetegragene autotemcel
• Mavorixafor

• Ritlecitinib

  • Treatment of moderate to severe alopecia areata(AA) patients with 50% or greater scalp hair loss (including alopecia totalis [AT] and alopecia universalis [AU])
• Sizavaleucel
• Sutimlimab
• Voclosporin

• Vonoprazan

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

Darmkanker

• Eflornithine / sulindac

Darmziekten

• Etrasimod

  • Ulcerative colitis (UC)

• Etrolizumab

  • Moderately to severely active Crohn's disease

• Filgotinib

  • Crohn disease (bowel disease) Moderately to Severe

• Mirikizumab

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

• Risankizumab

  • Skyrizi is geïndiceerd voor de behandeling van volwassen patiënten met matig tot ernstig actieve ziekte van Crohn die onvoldoende hebben gereageerd op, niet meer reageren op of intolerant waren voor conventionele behandeling of een biologische behandeling.
  • Indicated for UC (collitis ulcerosa) with demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.

• Teduglutide

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

• Upadacitinib

  • Extension of indication to include treatment of moderately to severely active Crohn's disease in adult patients.
  • 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

• Donanemab
• Gantenerumab

Depressie

• Agomelatine ^IND
• 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.

Diabetes

• Bexagliflozine
• Dulaglutide ^IND

• 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 ^IND
• Insuline Icodec
• Polyethylene glycol loxenatide
• Regulatoire T-cellen (TREGS)

• Sotagliflozine

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

• Tirzepatide

  • Voor de behandeling van volwassenen met onvoldoende gereguleerde diabetes mellitus type 2, als aanvulling op dieet en lichaamsbeweging • als monotherapie wanneer metformine niet geschikt blijkt te zijn vanwege intolerantie of contra-indicaties • in aanvulling op andere geneesmiddelen voor de behandeling van diabetes.

Duchenne

• Fordadistrogene movaparvovec

• Givinostat

  • Ambulant Patients With Duchenne Muscular Dystrophy
• Golodirsen

• Vamorolone

  • Treatment of Duchenne muscular dystrophy.
• Viltolarsen

Eierstokkanker

• Dostarlimab

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

• Rucaparib

  • Extension of indication to include maintenance treatment of adult patients with advanced (FIGO Stages III and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to first-line platinum-based chemotherapy.

Epilepsie

• 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.

• Fenfluramine

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

Fungale infecties

• Ibrexafungerp

  • Patients with acute Vulvovaginal Candidiasis
• Oteseconazole
• Rezafungin

HIV

• Doravirine / ​lamivudine / ​tenofovirdisoproxil ^IND

• 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
• UB 421

Hematologie, overig

• Lenzilumab

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
• Fidanacogene elaparvovec
• Valoctocogene roxaparvovec

Hersenkanker

• Dabrafenib / trametinib

  • Indicated for the treatment of paediatric and young adult patients with unresectable low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. Indicated for the treatment of paediatric and young adult patients unresectable high-grade glioma with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.

Hoofd- en halskanker

• Pembrolizumab

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

• Tislelizumab

  • 1L recurrent/metastatic nasopharyngeal cancer (NPC).

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

  • Acute treatment of migraine with or without aura in adults
  • Preventive treatment of episodic migraine in adults who have at least 4 migraine attacks per month

Huidkanker

• Darleukin fibromun

• Ipilimumab

  • Extension of indication to include in combination with nivolumab the treatment of adolescents (12 years of age and older) for advanced (unresectable or metastatic) melanoma.

• Lenvatinib

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

• Lifileucel

  • Malignant melanoma, advanced melanoma.

• Nivolumab

  • Extension of indication to include adolescent patients aged 12 years and older in treatment of advanced (unresectable or metastatic) melanoma (nivolumab monotherapy), treatment of advanced (unresectable or metastatic) melanoma (nivolumab in combination with ipilimumab) and adjuvant treatment of melanoma (nivolumab monotherapy).

• Pembrolizumab

  • 1L treatment with pembrolizumab for advanced melanoma, in combination with lenvatinib.
  • KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection
• Relatlimab / nivolumab
• Tavokinogene telseplasmid

Huidziekten

• Baricitinib

  • Pediatric atopic dermatitis
• Beremagene geperpavec
• Berkenschorsextract
• Concentrate of proteolytic enzymes enriched in bromelain ^IND
• Dabocemagene autoficel

• 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 indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.

• Lebrikizumab

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

• Roflumilast topicaal

  • Chronic plaque psoriasis

• Ruxolitinib phosphate

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

• Secukinumab

  • Extension of indication to include treatment of Hidradenitis Suppurativa (HS) for Cosentyx.

• Sirolimus

  • Treatment of angiofibroma associated with tuberous sclerosis complex

• Spesolimab

  • Spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy.

• Tralokinumab

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

Infectieziekten, overig

• Baloxavir marboxil

  • Extension of indication for the treatment of uncomplicated influenza and post-exposure prophylaxis of influenza in patients aged 1 years and above.
• Cefepime / Enmetazobactam
• Fluticasone propionate

Leverkanker

• Atezolizumab

  • Atezolizumab plus bevacizumab in high-risk hepatocellular carcinoma after curative resection or ablation

• 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).

• Tremelimumab

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

Leverziekten

• Arachidyl amido cholanoic acid

• Maralixibat

  • Treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.
• 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).

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

  • 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.

• Cabozantinib

  • Cabozantinib combined with atezolizumab in patients with metastatic non-small cell lung cancer previously treated with only 1 anti-PD-L1/PD-1 checkpoint-inhibitor and platinum-containing chemotherapy, either sequentially or concurrently (without a targetable oncogenic driver) for 2L or 3L (line depending on previous treatment regime)
• 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.

• 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

• 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

  • 1L squamous NSCLC (combi): In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of locally advanced or metastatic squamous NSCLC in adults
  • 2L NSCLC (mono): As monotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults
  • 1L non-squamous NSCLC (combi): In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of locally advanced or metastatic non-squamous NSCLC in adults whose tumors have no EGFR or ALK positive mutations

• 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

• 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

• Nintedanib

  • Treatment of chronic fibrosing interstitial lung diseases in paediatric patients from 6 to 17 years.
• Pamrevlumab

• Pirfenidone

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

• Riociguat

  • Extension of indication to include treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged 6 to less than 18 years of age with WHO Functional Class (FC) I to III in combination with endothelin receptor antagonists with or without prostanoids for ADEMPAS

• tocilizumab

  • Extension of indication to include treatment of new indication for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD)

Maagkanker

• Catumaxomab

• Pembrolizumab

  • Treatment in the neoadjuvant or adjuvant setting of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
  • indication for treatment with pembrolizumab in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) in the treatment of HER2 negative advanced gastric or GEJ adenocarcinoma in adult participants.
  • indication for treatment with pembrolizumab plus trastuzumab in combination with standard of care chemotherapy for adults with HER2 positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
• Ripretinib

• Tislelizumab

  • 1L locally advanced or metastatic gastric carcinoma

• Trastuzumab deruxtecan

  • Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-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 geïndiceerd voor de behandeling van volwassen patiënten met recidiverend en refractair multipel myeloom, die minimaal drie eerdere behandelingen hebben gekregen, waaronder een immunomodulerend middel, een proteasoomremmer en een anti-CD38-antilichaam en die tijdens de laatste therapie ziekteprogressie hebben vertoond.

• Daratumumab

  • Multipel myeloom frontline behandeling in combinatie met VRd voor patiënten die niet in aanmerking komen voor een ASCT.
  • Smouldering multipel myeloom.
  • Multipel myeloom frontline behandeling in combinatie met VRd voor patiënten die in aanmerking komen voor een ASCT.

• Elranatamab

  • Indicated as monotherapy for the treatment of relapsed or refractory multiple myeloma in adult patients who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy

• 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

  • Pepaxti, in combinatie met dexamethason, is geïndiceerd voor de behandeling van volwassen patiënten met multipel myeloom die minstens drie eerdere therapielijnen hebben gekregen, bij wie de ziekte refractair is voor ten minste één proteasoomremmer, één immunomodulerend middel en één antiCD38-monoklonaal antilichaam, en die tijdens of na hun laatste therapie ziekteprogressie vertoonden. Bij patiënten die eerder een autologe stamceltransplantatie hebben ondergaan, moet er tussen die transplantatie en de progressie ten minste drie jaar zijn verstreken.

• 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

  • in combinatie met bortezomib en dexamethason voor de behandeling van volwassen patiënten met multipel myeloom die ten minste één eerdere therapie hebben ondergaan.

• Teclistamab

  • Tecvayli is indicated as monotherapy 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.
• Thalidomide ^G

• Venetoclax

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

Multiple sclerose

• Dimethyl fumarate

  • Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

• Natalizumab

  • actieve relapsing-remitting multiple sclerose (zie indicatie huidige spécialité

• Teriflunomide

  • Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).
  • Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).

• Ublituximab

  • Relapsing multiple sclerosis

Myeloproliferatieve aandoeningen

• Momelotinib
• Navitoclax

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

  • Children and Adolescents With Fragile X Syndrome aged 3 to < 18 years.
• Clazosentan
• Eladocagene exuparvovec

• Inebilizumab

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

• Ravulizumab

  • Extension of indication to include the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin 4 (AQP4) antibody-positive.

• 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))
• Trofinetide

• Vutrisiran

  • treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

Nierkanker

• Cabozantinib

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

• 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

• Acalabrutinib

  • Mantle cell lymphoma (MCL), 1L.

• Axicabtagene ciloleucel

  • Yescarta is indicated for the treatment of adult patients with diffuse large B‑cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.

• 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.

• 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)

• Epcoritamab

  • Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Large B-Cell Lymphoma (LBCL).

• Glofitamab

  • 3L Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (r/r DLBCL)

• 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.
  • Extension of indication to include treatment of adult patients with Second-line (2L) Transplant Intended (TI) Large B-Cell Lymphoma (LBCL) for Breyanzi.

• Loncastuximab tesirine

  • Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.

• Pirtobrutinib

  • Mantle Cell Lymphoma (MCL)

• Polatuzumab vedotin

  • Polivy in combinatie met rituximab, cyclofosfamide, doxorubicine en prednison (R-CHP) is geïndiceerd voor de behandeling van volwassen patiënten met niet eerder behandeld diffuus grootcellig B-cellymfoom (DLBCL).

• 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.
• 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

• 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.

Onbekend

• Diazoxide choline (controlled-release tablet)
• 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

• Pirfenidone

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

• Relugolix

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

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

  • Imfinzi in combination with gemcitabine and cisplatin is indicated for the first‑line treatment of adults with unresectable 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
• Nirogacestat

• Pembrolizumab

  • indication for treatment with pembrolizumab plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma
  • 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 geïndiceerd als monotherapie voor de behandeling van humaan leukocytenantigeen (HLA)-A*02:01-positieve volwassen patiënten met een niet-resectabel of gemetastaseerd uveamelanoom.

• Tislelizumab

  • 1L locally advanced or metastatic ESCC (esophageal squamous-cell carcinoma)
  • 2L locally advanced or metastatic ESCC (esophageal squamous-cell carcinoma)

Oogaandoeningen

• Aflibercept

  • Eylea is indicated in preterm infants for the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or AP-ROP (aggressive posterior ROP) disease.
  • Diabetic macular edema
• Avacincaptad pegol

• 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
• Polihexanide

• 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

Overige medicatie hart-en vaatziekten

• Angiotensin II

• Dapagliflozine

  • Extension of indication to include population with Heart Failure and LVEF > 40% (HFpEF).
• Etripamil
• Icosapent ethyl

• Macitentan

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

• Mavacamten

  • Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy
• Neoatricon (dopamine)
• 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

• Sotatercept

  • Treatment of Pulmonary Arterial Hypertension
• Tadalafil ^IND

• Treprostinil

  • Behandeling van idiopatische of erfelijke primaire pulmonale arteriële hypertensie bij matig-ernstig hartfalen (NYHA-klasse III).
• Valsartan / sacubutril ^IND

Overige niet-oncologische hematologische medicatie

• Crizanlizumab
• Danicopan
• Daprodustat

• Eculizumab

  • Paroxysmal nocturnal haemoglobinuria

• Efgartigimod

  • Idiopathic thrombocytopenic purpura (ITP)

• 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
• Eptacog alfa ^IND
• Exagamglogene autotemcel
• Ferumoxytol
• Horse anti-human T lymphocyte immunoglobulin

• Iptacopan

  • Paroxysmal nocturnal haemoglobinuria (PNH) in adults with active haemolysis

• Luspatercept

  • Extension of indication in β-thalassaemia to include adult patients with non-transfusion dependent β-thalassaemia (NTDT).
• Methoxy polyethylene glycol-epoetin beta ^IND

• Mitapivat

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

• Pegcetacoplan

  • Paroxysmal nocturnal haemoglobinuria (PNH)

• Ravulizumab

  • Treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) in patients with haemolysis with clinical symptom(s) indicative of high disease activity and in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months.
  • 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

Parkinson

• Levodopa / carbidopa

  • Parkinson

Pijn

• Bupivacaine

  • Extension of indication to include children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.
• Buprenorfine ^IND
• Fasinumab
• SDN037

Prostaatkanker

• Darolutamide

  • Adult men with metastatic hormone senstive prostate cancer (mHSPC) in combination with docetaxel en ADT.

• Degarelix

  • Vergevorderd hormoonafhankelijk prostaatcarcinoom; Hoog-risico gelokaliseerd of lokaal gevorderd hormoonafhankelijk prostaatcarcinoom: in combinatie met radiotherapie of als neo-adjuvante behandeling voorafgaand aan radiotherapie.

• Enzalutamide

  • Niet-gemetastaseerd hormoonsensitief prostaatcarcinoom (nmHSPC)
• Gozetotide
• 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 and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated.

• 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.

• Talazoparib

  • TALZENNA (talazoparib) is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).

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.

• Baricitinib

  • Extension of indication to include treatment, as monotherapy or in combination with conventional synthetic disease modifying antirheumatic drugs (DMARDs), of active juvenile idiopathic arthritis (JIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic DMARDs.

• Bimekizumab

  • Extension of indication to include treatment of adults with active axial spondyloarthritis (axSpA), including non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
  • Extension of indication to include Bimzelx, alone or in combination with conventional disease-modifying antirheumatic drugs (cDMARDs), 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 DMARDs.
• Cyclobenzaprine hydrochloride

• 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 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

• Tocilizumab

  • Rheumatoid arthritis (RA), giant lymph node hyperplasia (Castlesman’s disease), polyarticular idioathic juvenile arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA).

• Upadacitinib

  • RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

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

  • Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced RET mutant medullary thyroid cancer (MTC)
  • 1L treatment advanced or metastatic RET fusion-positive thyroid cancer (TC)

Schizofrenie, psychose, bipolaire stoornis

• Roluperidon

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).
  • Extension of indication to include treatment of narcolepsy with or without cataplexy in adolescents and children from the age of 6 years.

Spierziekten, overig

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

• Efgartigimod

  • Vyvgart is geïndiceerd als een aanvulling op de standaardtherapie voor de behandeling van volwassen patiënten met gegeneraliseerde myasthenia gravis (gMG) die positief testen op antilichamen tegen acetylcholinereceptoren (AChR).
• Omaveloxolone

• Ravulizumab

  • Ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody-positive.
• Rozanolixizumab

• Satralizumab

  • Generalized Myasthenia
• Zilucoplan

Stamceltransplantaties

• Narsoplimab
• Omidubicel

• Plerixafor

  • Multiple Myeloma; Hematopoietic Stem Cell Transplantation

• 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

• Treosulfan

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

• UM171

  • Allogeneic haematopoietic stem cell transplants

Stofwisseling en Endocrinologie, overig

• Abaloparatide

  • Treatment of osteoporosis.
  • Treatment of osteoporosis in postmenopausal women at increased risk of fracture

• Alpelisib

  • PIK3CA-Related Overgrowth Spectrum (PROS). PROS omvat de onderstaande syndromen: - goedaardige lichenoïde keratose (BLK) - dysplastische megalencefalie (DMEG) - CLOVES (aangeboren lipomateuze overgroei, vasculaire malformatie, epidermal naevi-syndroom) - Epidermal naevi (EN) - fibro-adipeuze overgroei (FAO) - Hemimegalencefalie (HMEG) - hemihyperplasie - meervoudige lipomatose (HHML) geïsoleerde grote lymfatische malformatie (ILM) - megaencefalie- capillaire malformatie (MCAP) - Muscular hemihyperplasia (mHH) - seborrhoïsche keratose (SK)

• 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
• Ganirelix ^G

• Linzagolix

  • Moderate to Severe Endometriosis Associated Pain
• Ospemifene ^IND

• Pegzilarginase

  • Hyperargininaemia

• Semaglutide

  • Extension of indication to include treatment of adolescents for weight management for Wegovy.
  • For weight management in people with obesity or who are overweight and have other related conditions.

• 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.
  • IMCIVREE is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet‑Biedl syndrome (BBS), 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.

• Vosoritide

  • Voxzogo is indicated for the treatment of achondroplasia in patients 2 years of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

Stofwisselingsziekten

• ALXN1840
• 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
• Cipaglucosidase alfa / miglustat

• Empagliflozine

  • Treatment of patients with chronic kidney disease.
• Fexapotide
• Fezolinetant
• Fosdenopterin
• Leriglitazone

• 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).
• Lixivaptan

• 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.

• Octreotide

  • Mycapssa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.
• Olenasufligene relduparvovec
• Olipudase alfa
• Palovarotene
• Pegunigalsidase alfa
• RGX-121
• Reloxaliase

• Somapacitan

  • Sogroya is indicated for the replacement of endogenous growth hormone in children with growth hormone deficiency.

• 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
• TransCon PTH (palopegteriparatide)

Taaislijmziekte

• Lumacaftor / ivacaftor

  • Extension of indication to include treatment of cystic fibrosis for children aged 1 to less than 2 years old of age who are homozygous for the F508del mutation in the CFTR gene.

Tumoragnostische geneesmiddelen

• Selpercatinib

  • 2L+tumour agnostic–RET positive, no other satisfactory options

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.

• Letermovir

  • Letermovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients
  • Extension of Letermovir From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant

• Lonafarnib

  • Hepatitis D infection with ritonavir
• Maribavir

• Nirsevimab

  • Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season.
• Posoleucel
• Tenofovir alafenamide ^IND