Gepubliceerd op 6 juni 2023

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).

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

• Masitinib

  • Amyotrophic lateral sclerosis (ALS), add on in patients on a stable dose of riluzole.
• Sodium phenylbutyrate / ursodoxicoltaurine
• Tofersen ^IND

AML/MDS

• 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

• Gilteritinib

  • A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML).
• Iomab-B

• Ivosidenib

  • Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy.
• Magrolimab

• 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

• Aprocitentan
• Dabigatran ^G
• Proteïne C ^IND

Astma

• 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

• Cadonilimab

• 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

• Bezlotoxumab
• Ceftobiprole
• 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.
• Gepotidacin
• Oritavancin diphosphate ^IND
• Ridinilazole
• SER 109
• Tebipenem

Blaaskanker

• Durvalumab

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

• Enfortumab vedotin

  • Enfortumab Vedotin and Pembrolizumab in Untreated Locally Advanced or Metastatic Urothelial Cancer

• 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 is, in combinatie met endocriene therapie, geïndiceerd voor de adjuvante behandeling van volwassen patiënten met hormoonreceptor (HR)-positieve, humane epidermale groeifactorreceptor 2 (HER2)-negatieve, klierpositieve vroege borstkanker met een hoog risico op recidief

• Atezolizumab

  • Atezolizumab plus chemotherapy for patients with early relapsing recurrent triple-negative breast cancer
• Balixafortide

• Capivasertib

  • Locally advanced (inoperable) or metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) breast cancer following recurrence or progression on or after endocrine therapy.
• 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

  • Extension of indication to include treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
  • 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 HER2-low/ultra-low hormone receptor positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
  • Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2‑low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
  • 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

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).

• 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

• 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 adults and adolescents aged 12 years and older weighing at least 40 kg and receiving supplemental oxygen, who have a negative SARS-CoV-2 antibody test result.
  • 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

  • Extension of indication to include treatment of adult patients with indolent systemic mastocytosis (ISM).

• Baricitinib

  • Uitbreiding indicatie met de behandeling van ernstige alopecia areata bij volwassen patiënten
• Budesonide modified released capsule
• Coacillium topical

• Dupilumab

  • Dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.
• FCR 001

• Leniolisib

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

• Ritlecitinib

  • Treatment of severe alopecia areata in adults and adolescents 12 years of age and older
• Sizavaleucel
• Sutimlimab
• Voclosporin

Darmkanker

• Eflornithine / sulindac
• Fruquintinib

• Trifluridine / tipiracil

  • Extension of indication to include treatment of patients with refractory metastatic colorectal cancer, for LONSURF in combination with bevacizumab.

Darmziekten

• Budesonide

  • Proctitis Ulcerosa (mild matig)

• Etrasimod

  • Treatment of patients 16 years of age and older 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 biological agent or a JAK inhibitor

• Etrolizumab

  • Moderately to severely active Crohn's disease

• Filgotinib

  • Crohn disease (bowel disease) Moderately to Severe
• Glepaglutide

• Mirikizumab

  • Omvoh is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment

• 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

  • Revestive is indicated for the treatment of patients 4 months corrected gestational age 1 year and above with Short Bowel Syndrome (SBS). Patients should be stable folllowing a period of intestinal adaptation after surgery.

• Upadacitinib

  • RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. RINVOQ is geïndiceerd voor de behandeling van volwassen patiënten met matige tot ernstige actieve ziekte van Crohn die onvoldoende reageerden op, niet meer reageerden op of intolerant waren voor een conventionele behandeling of een biologisch geneesmiddel (‘biological’).

Dementie

• Blarcamesine
• Donanemab
• Hydromethylthionine mesylaat
• Lecanemab

Depressie

• Agomelatine ^IND
• Bupropion / dextromethorphan

Diabetes

• Bexagliflozine

• Dasiglucagon

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

• Empagliflozine

  • Extension of indication for Jardiance to include treatment of children aged 10 years and above with type 2 diabetes.

• Finerenon

  • 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 Icodec
• Insulin lispro ^IND
• Polyethylene glycol loxenatide
• Regulatoire T-cellen (TREGS)
• 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
• Losmapimod

• Vamorolone

  • Treatment of Duchenne muscular dystrophy.
• Viltolarsen

Eierstokkanker

• Dostarlimab

  • Extension of indication to include in combination with platinum -containing chemotherapy the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability -high (MSI -H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy
  • 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

  • Extension of indication to include treatment with Epidyolex (monotherapy) as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS) for patients 2 years of age and older (without the restriction for use only in conjunction with clobazam.

• 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

Fungale infecties

• Oteseconazole
• Rezafungin

HIV

• Raltegravir ^BS
• Semzuvolimab

Hematologie, overig

• Lenzilumab

• Luspatercept

  • Extension of indication to include treatment of adult patients with anaemia due to very low, low and intermediate -risk myelodysplastic syndromes (MDS), who may require RBC transfusions for Reblozyl.

• Obinutuzumab

  • Extension of indication to include the pre-treatment to reduce the risk of cytokine release syndrome (CRS) induced by glofitamab for Gazyvaro.

Hemostase bevorderende medicatie

• Emicizumab

  • Hemlibra is indicated for Routine prophylaxis of bleeding episodes in patients with haemophilia A without factor VIII inhibitors who have moderate disease with severe bleeding phenotype.
• Eptacog beta (activated)
• Etranacogene dezaparvovec
• Fidanacogene elaparvovec
• Nonacog beta pegol ^IND
• Peboctocogene camaparvovec
• Valoctocogene roxaparvovec

• Vonicog alfa

  • Extension of indication to include prophylactic treatment to prevent or reduce the frequency of bleeding episodes in Pediatric and Adult Patients.

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.

Hodgkin lymfoom

• Brentuximab vedotin

  • xtension of indication to include treatment of adult patients with previously untreated CD30+ advanced (including Stage III) Hodgkin lymphoma (HL), in combination with doxorubicin, vinblastine and dacarbazine (AVD).

Hoofd- en halskanker

• Atezolizumab

  • Adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck.

• Leukocyte interleukin

  • Cancer of the oral cavity, neoadjuvant

• 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).
  • Extension of indication to include OPDIVO for the adjuvant treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma who have undergone complete resection.

• Pembrolizumab

  • 1L treatment with pembrolizumab for advanced melanoma, in combination with lenvatinib.
• Relatlimab / nivolumab
• Tavokinogene telseplasmid

Huidziekten

• Baricitinib

  • Extension of indication to include the treatment of paediatric patients (from 2 years of age and older) with moderate to severe atopic dermatitis for Olumiant.
• Beremagene geperpavec
• Berkenschorsextract
• Concentrate of proteolytic enzymes enriched in bromelain ^IND
• Dabocemagene autoficel
• Delgocitinib

• Deucravacitinib

  • Sotyktu is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
• Difelikefalin

• Dupilumab

  • Extension of indication to include treatment of severe atopic dermatitis in paediatric patients from 6 months to <6 years of age.
  • Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.
• Methotrexaat
• Piclidenoson
• Regenerative Skin Tissue

• Roflumilast topicaal

  • Chronic plaque psoriasis

• Ruxolitinib phosphate

  • Opzelura is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

• Secukinumab

  • Extension of indication to include treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy

• Sirolimus

  • Hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older.

• 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
• Cefepime/taniborbactam
• Fluticasone propionate

Leverkanker

• Atezolizumab

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

• Durvalumab

  • Imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).
  • Durvalumab (+/- bevacizumab) in combinatie met TACE in patiënten met locoregionale HCC.

• Tremelimumab

  • Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).

Leverziekten

• Arachidyl amido cholanoic acid

• Maralixibat

  • Treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.
  • Extension of indication to include treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) in patients 2 months of age and older

• Obeticholic acid

  • Fibrosis due to Non-Alcoholic Steatohepatitis (NASH)

• Odevixibat

  • Extension of indication to include treatment of cholestasis and pruritus in Alagille syndrome (ALGS) in patients from birth and older for BYLVAY.
• Resmetirom
• Seladelpar

Lipidenverlagende medicatie

• Alirocumab

  • Extension of indication to include treatment of paediatric patients 8 years of age and older with heterozygous familial hypercholesterolemia (HeFH) as an adjunct to diet, alone or in combination with other LDL -C lowering therapies.
• 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

• Atezolizumab

  • Neoadjuvant atezolizumab with chemotherapy in patients with resectable stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC).
  • Atezolizumab subcutaneous in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC).
  • 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
• Aumolertinib (mesilate)

• 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

  • LIBTAYO in combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with NSCLC expressing PD-L1 (in ≥ 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC.
  • 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.

• Domvanalimab

  • first-line treatment of patients with metastatic non-small cell lung cancer with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations

• Durvalumab

  • Imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations.
  • 1L advanced NSCLC
  • Limited stage small cell lung cancer (LS-SCLC) following concurrent platinum-based chemotherapy and radiation therapy in combination with Tremelimumab.
  • 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.

• Nintedanib

  • Treatment of non-small cell lung cancer (NSCLC)

• Nivolumab

  • OPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1%
• OSE-2101

• Osimertinib

  • Stage III unresectable Epidermal Growth Factor Receptor (EGFR) mutation positive non-small cell lung cancer (NSCLC)
  • Osimertinib with platinum plus pemetrexed chemotherapy as first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.

• Pembrolizumab

  • Extension of indication to include in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant, treatment of resectable stage II, IIIA, or IIIB (T3 4N2) non-small cell lung carcinoma in adults.
  • 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.

• 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.

• Serplulimab

  • Treatment of extensive-stage small cell lung cancer (ES-SCLC)

• Sugemalimab

  • First-line treatment-naive subjects with stage IV non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy.

• 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

  • Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.

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 treatment of ‘advanced’ idiopathic pulmonary fibrosis (IPF) by the deletion of the current qualifier ‘mild to moderate’, in IPF patients with advanced lung function impairment (DLco < 40% of predicted) and at high risk of grade 3 pulmonary hypertension.

• Riociguat

  • Adempas is indicated for the treatment of PAH in paediatric patients aged less than 18 years of age and body weight ≥ 50 kg with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists.

• Sotatercept

  • Treatment of Pulmonary Arterial Hypertension
• Tadalafil ^IND

• 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

• Domvanalimab

  • previously untreated locally advanced unresectable or metastatic gastric, gastroesophageal junction, and esophageal adenocarcinoma

• Nivolumab

  • Gastric cancer 3/4e lijn

• Pembrolizumab

  • Treatment in the neoadjuvant or adjuvant setting of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
  • Extension of indication to include in combination with chemotherapy the first -line treatment of locally advanced unresectable or metastatic HER2 -negative gastric or gastrooesophageal junction adenocarcinoma in adults.
  • Extension of 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

• 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

• 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 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

  • Extension of indication to include treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD-38 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

  • Extension of indication to include treatment of patients with Multiple Myeloma who have received at least two prior lines of therapies for PEPAXTI.
  • 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, 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

  • Treatment of adult patients with relapsed and refractory multiple myeloma in combination with dexamethasone

• Selinexor

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

• Talquetamab

  • Patients With Relapsed or Refractory Multiple Myeloma (4L).

• 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

• Natalizumab

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

• Ublituximab

  • Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features

Myeloproliferatieve aandoeningen

• 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.
• Momelotinib
• Navitoclax
• Pelabresib

• Pemigatinib

  • Myeloid/Lymphoid Neoplasms ((8p11 var)

Neurologie, overig

• Cannabidiol

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

• Human normal immunoglobulin

  • Extension of indication to include treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in adults.

• Inebilizumab

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

• Ravulizumab

  • Ultomiris is indicated in the treatment of adult patients with NMOSD who are anti-aquaporin 4 (AQP4) antibody-positive

• Tiratricol

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

• Vutrisiran

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

Nierkanker

• Atezolizumab

  • In combination with cabozantinib in patients with advanced renal cell carcinoma after immune checkpoint inhibitor treatment
• 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).

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.

• 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

  • Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

• Glofitamab

  • Columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL), after two or more lines of systemic therapy.

• Ibrutinib

  • 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

  • Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

• 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

  • Jaypirca as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor.

• 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.

• Epcoritamab

  • Relapsed or refractory follicular lymphoma
• Hypericin

• Ibrutinib

  • Follicular lymphoma (FL), relapsed / refractory.

• 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.

• 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.

• Zanubrutinib

  • Extension of indication to include in combination with obinutuzumab treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic treatments.

Onbekend

• Dasatinib

  • Indicated for the treatment of chronic myelogenous leukaemia (CML)
• Diazoxide choline (controlled-release tablet)
• Eplontersen

• Ibrutinib

  • Marginal zone lymphoma (MZL), relapsed / refractory.
• 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

• Pirfenidone

  • Pirfenidone Axunio is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).
• Relugolix / estradiol / norethisterone acetaat ^IND
• Relugolix / estradiol / norethisteronen
• Sofpironium bromide
• Tagraxofusp
• Vibegron

Oncologie, overig

• AL102
• Afamitresgene autoleucel

• 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

• Ivosidenib

  • Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 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.
• Melphalan hydrochloride
• 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.
  • 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.

• Retifanlimab

  • Monotherapy for the treatment of adult patients with Merkel Cell Carcinoma with distant metastatic disease or recurrent advanced locoregional disease not amenable to surgery or radiation

• 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)

• Toripalimab

  • Toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (“ESCC”)
  • Toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (“NPC”)

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
• Bevacizumab-vikg
• Bimatoprost
• Botaretigene sparoparvovec

• Faricimab

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

• Reproxalap

  • Moderate to severe dry eye disease
• Sepofarsen
• Varenicline

Overige medicatie hart-en vaatziekten

• Angiotensin II

• Dapagliflozine

  • dapagliflozin is indicated in adults for the treatment of symptomatic chronic heart failure
• Etripamil
• Icosapent ethyl

• Macitentan

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

• Mavacamten

  • Camzyos is indicated for the treatment of symptomatic (New York Heart Association, NYHA, class II III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients.
• 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

• Valsartan / sacubitril

  • Extension of indication to include treatment of children and adolescents aged one year or older with chronic heart failure with left ventricular systolic dysfunction.

• 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

• Bentracimab

• Concizumab

  • Hemofilie A met inhibitors en hemofilie B met inhibitors
  • Hemofilie A en B zonder inhibitors
• Crizanlizumab
• Crovalimab
• Danicopan
• Daprodustat

• Eculizumab

  • Paroxysmal nocturnal haemoglobinuria
• Efanesoctocog alfa

• Efgartigimod

  • Idiopathic thrombocytopenic purpura (ITP)
• Exagamglogene autotemcel
• Ferumoxytol

• Hydroxycarbamide

  • Extension of indication to include the prevention of vaso-occlusive complications of sickle cell disease in children from 6 months to 2 years of age for Xromi.

• Iptacopan

  • Treatment of adult patients with paroxysmal nocturnal haemoglobinuria.

• Luspatercept

  • Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion-dependent and non-transfusion-dependent beta-thalassaemia 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)
  • Extension of indication to include treatment of adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not previously treated with a complement inhibitor

• 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
• Difluprednate
• Fasinumab

Prostaatkanker

• Atezolizumab

  • In combination with cabozantinib patients with mCRPC previously treated with novel hormonal therapy (NHT)

• Darolutamide

  • Nubeqa is indicated for the treatment of adult men with metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy .

• 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

• Lutetium (177lu) vipivotide tetraxetan

  • Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane based chemotherapy.

• Masitinib

  • Metastatic Castration-resistant Prostate Cancer

• Niraparib / abirateron

  • Akeega is indicated with prednisone or prednisolone for the treatment of adult patients with metastatic castration resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.

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

• 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

• 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

  • Bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.
  • Bimzelx, alone or in combination with methotrexate, 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).
• Cyclobenzaprine hydrochloride

• Sarilumab

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

• Tocilizumab

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

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

• 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)
  • Extension of indication to include the treatment of adults and adolescents 12 years and older with advanced RET fusion-positive thyroid cancer in the first-line setting for Retsevmo.

Schizofrenie, psychose, bipolaire stoornis

• Roluperidon

Slaapstoornissen

• Daridorexant
• Natriumoxybaat controlled release

• Pitolisant

  • 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

• Eculizumab

  • Extension of indication to include treatment of paediatric patients aged 6 to less than 18 years with acetylcholine receptor-antibody (AChR-Ab) positive (+) refractory gMG.
  • Extension of indication to include treatment of paediatric patients with refractory generalised myasthenia gravis (gMG).

• 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

• Abatacept

  • Extension of indication to include the prophylaxis of acute Graft versus Host Disease (aGvHD) in the adult and paediatric population for Orencia.
• ECT-001-CB
• Narsoplimab
• Omidubicel

• Plerixafor

  • Multiple Myeloma; Hematopoietic Stem Cell Transplantation
• Tabelecleucel

• Treosulfan

  • Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients, and in paediatric patients older than one month with malignant and non‑malignant diseases.

Stofwisseling en Endocrinologie, overig

• Abaloparatide

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

• Linzagolix

  • Moderate to Severe Endometriosis Associated Pain
• Ospemifene ^IND

• Pegzilarginase

  • Hyperargininaemia

• Semaglutide

  • Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with obesity and body weight above 60 kg. Treatment with Wegovy should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose.
  • For weight management in people with obesity or who are overweight and have other related conditions.

• Tirzepatide

  • Extension of indication to include chronic weight management, including weight loss and weight maintenance, for MOUNJARO.

• Vosoritide

  • Extension of indication to include treatment of children less than 2 years of age, Voxzogo is indicated for the treatment of achondroplasia.

Stofwisselingsziekten

• ALXN1840

• Afamelanotide

  • Extension of indication for the prevention of phototoxicity in adolescent patients (12 to under 18 years of age) with erythropoietic protoporphyria (EPP).
• Avalglucosidase alfa
• Bardoxolone Methyl
• Cipaglucosidase alfa

• Empagliflozine

  • Treatment of patients with chronic kidney disease.
• 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).

• 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
• Palopegteriparatide
• Palovarotene
• Pegunigalsidase alfa
• RGX-121

• Somapacitan

  • Sogroya is indicated for the replacement of endogenous growth hormone (GH) in children aged 3 years and above and adolescents with growth failure due to growth hormone deficiency (paediatric GHD), and in adults with growth hormone deficiency (adult GHD)

• 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

• 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

  • Extension of indication for Retsevmo to include the treatment of adults with advanced or metastatic RET fusion-positive solid tumours with disease progression on or after prior systemic therapies or who have no satisfactory therapeutic 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

  • Extension of indication to include treatment of prophylaxis of cytomegalovirus in kidney transplant recipients (KTR) for PREVYMIS.
  • 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.
  • Extension of indication to include treatment of children up to 24 months of age who remain vulnerable to severe Respiratory Syncytial Virus (RSV) disease through their second RSV season
• Posoleucel
• Tenofovir alafenamide ^IND