Gepubliceerd op 7 december 2021

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

• Blinatumomab

  • Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor ALL as part of the consolidation therapy.

• Dasatinib

  • Geïndiceerd voor de behandeling van volwassen patiënten met: nieuw gediagnosticeerde Philadelphiachromosoom-positieve (Ph+) chronische myeloïde leukemie (CML) in de chronische fase. CML in de chronische, acceleratie- of blastaire fase, die resistent of intolerant zijn voor eerder toegediende geneesmiddelen inclusief imatinib. Ph+ acute lymfoblastaire leukemie (ALL) en lymfoïde blasten CML die resistent of intolerant zijn voor eerder toegediende geneesmiddelen. Ook geïndiceerd voor de behandeling van pediatrische patiënten met: nieuw gediagnosticeerde Ph+ CML in de chronische fase (Ph+ CML-CP) of met Ph+ CML-CP die resistent of intolerant zijn voor eerder toegediende geneesmiddelen waaronder imatinib. Nieuw gediagnosticeerde Ph+ ALL in combinatie met chemotherapie.
  • Geïndiceerd voor de behandeling van volwassen patiënten met: nieuw gediagnosticeerde Philadelphiachromosoom-positieve (Ph+) chronische myeloïde leukemie (CML) in de chronische fase. CML in de chronische, acceleratie- of blastaire fase, die resistent of intolerant zijn voor eerder toegediende geneesmiddelen inclusief imatinib. Ph+ acute lymfoblastaire leukemie (ALL) en lymfoïde blasten CML die resistent of intolerant zijn voor eerder toegediende geneesmiddelen. Ook geïndiceerd voor de behandeling van pediatrische patiënten met: nieuw gediagnosticeerde Ph+ CML in de chronische fase (Ph+ CML-CP) of met Ph+ CML-CP die resistent of intolerant zijn voor eerder toegediende geneesmiddelen waaronder imatinib. Nieuw gediagnosticeerde Ph+ ALL in combinatie met chemotherapie.

• autologous anti-CD19-transduced CD3+ cells

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

ALS

• Arimoclomol

  • Amyotropic Lateral Sclerosis

AML/MDS

• Azacitidine

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

• Venetoclax

  • Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.

Alvleesklierkanker

• Eryaspase (asparaginase)

  • Behandeling van pancreatic adenocarcinoma die gefaald hebben op eerstelijns therapie.

Antitrombotische medicatie

• Dabigatran ^G
• Dabigatran etexilate ^IND

• Ravulizumab

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

Astma

• Budesonide / formoterol ^IND

• Dupilumab

  • Dupilumab in Children 6 to <12 Years of Age With Uncontrolled Persistent Asthma.

• Masitinib

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

• Tezepelumab

  • Severe, inadequately controlled asthma

Baarmoederhalskanker

• Cemiplimab

  • Cemiplimab is being investigated in recurrent, persistent, and/or metastatic cervical cancer (2L mono) with squamous cell histology, for which there is not a curative-intent option (surgery or radiation therapy with or without chemotherapy). Tumor progression or recurrence after treatment with platinum therapy (must have been used to treat metastatic, persistent, or recurrent cervical cancer).

• Lifileucel

  • Treatment of Patients With Cervical Carcinoma (2L)

Bacteriele infecties

• Bedaquiline

  • Sirturo is indicated for use as part of an appropriate combination regimen for pulmonary multidrug‑resistant tuberculosis (MDR‑TB) in adults and paediatric patients (5 years to less than 18 years of age and weighing at least 15 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
• Ceftobiprole
• Ceftolozane / tazobactam ^IND
• Citric acid / lactic acid / potassium bitartrate ^IND
• Clindamycin

• Delafloxacin

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

• Delamanid

  • Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents and children with a body weight of at least 30kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
  • Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, and children and infants with a body weight of at least 10kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

• Eravacycline

  • Xerava is indicated for the treatment of complicated intra-abdominal infections (cIAI) in adults.

• Imipenem / cilastatin / relebactam

  • Recarbrio is indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.
  • Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults. Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults.
• Ozenoxacine
• 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

  • Adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting (3L).

• Nivolumab

  • Extension of indication for Opdivo to include adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) who are at high risk of recurrence after undergoing radical resection of MIUC.
• Oportuzumab monatox

Borstkanker

• Abemaciclib

  • Extension of indication to include Verzenios in combination with endocrine therapy for adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence.

• Atezolizumab

  • 1L advanced or mTNBC +cobimetinib+(nab)paclitaxel
  • Extension of indication to include Tecentriq in combination with nab-paclitaxel and anthracycline-based chemotherapy for the neoadjuvant treatment of adult patients with locally advanced or early Triple Negative Breast Cancer (TNBC).
• Balixafortide
• Efbemalenograstim alfa
• Margetuximab

• Neratinib

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

• Olaparib

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

• Paclitaxel

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

• Pembrolizumab

  • Extension of indication for Keytruda to include in combination with chemotherapy, treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease.
  • Extension of indication for Keytruda in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery of adults with locally advanced, inflammatory, or earlystage triple-negative breast cancer at high-risk of recurrence.
• Pertuzumab / trastuzumab

• Sacituzumab govitecan

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

• Trastuzumab deruxtecan

  • Patients with HER2 low, unresectable, and/or metastatic breast cancer previously treated with 1-2 prior lines of chemotherapy in the metastatic setting and has progressed on, and would no longer benefit from, endocrine therapy.
  • Treatment of adult patients with Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane 2L.
  • Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti HER2 based regimens.
• Trastuzumab duocarmazine

• Tucatinib

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

Borstvlieskanker

• Nivolumab

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

CLL

• Acalabrutinib

  • Calquence as monotherapy is indicated for the treatment of adult patients with relapsed/refractory CLL (chronic lymphocytic leukemia).
  • Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
• Duvelisib

• Ibrutinib

  • Extension of indication in chronic lymphocytic leukaemia (CLL) to add combination with rituximab as follows; Ibrutinib in combination with rituximab or obinutuzumab for the treatment of adult patients with previously untreated CLL (Young and Fit).
  • Extension of indication to the existing chronic lymphocytic leukaemia (CLL) indication to include combination use with obinutuzumab for the treatment of adult patients with previously untreated CLL.
• Moxetumomab pasudotox

• Ublituximab

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

• Zanubrutinib

  • Previously Untreated CLL or SLL

• ibrutinib

  • In combinatie met venetoclax voor eerstelijns CLL.

CML

• Asciminib

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

COPD

• Beclometason/formoterol/glycopyrronium

  • Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist

COVID-19

• APN01

• Anakinra

  • Extension of indication to include treatment of coronavirus disease 2019 (COVID -19) in adult patients with pneumonia who are at risk of developing severe respiratory failure for Kineret.
• Bamlanivimab/ etesevimab

• 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

• Dapagliflozine

  • Treatment of hospitalized adult patients with COVID-19 to prevent organ damage and to improve survival.
• Molnupiravir
• PF-07321332 / ritonavir
• Regdanvimab ^IND

• Remdesivir

  • Extension of indication to include adults who do not require invasive mechanical ventilation at start of treatment. • In adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment).
• Sotrovimab

• Tocilizumab

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

Chronische immuunziekten, overig

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

• Baricitinib

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

• Belimumab

  • Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.

• Berotralstat

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

• Canakinumab

  • Syndroom van Schnitzler

• Icatibant

  • Acute aanvallen van erfelijk angio-oedeem (HAE) bij volwassenen en kinderen vanaf 2 jaar met C1-esteraseremmerdeficiëntie.

• Imlifidase

  • Idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. The use of Idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.
• MDR-101
• Mavorixafor
• RP-L201
• Sutimlimab
• Teprotumumab
• Voclosporin

Darmkanker

• Eflornithine / sulindac

• Nivolumab

  • Extension of indication in combination with ipilimumab to include treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC) for combination treatment with Opdivo and Yervoy;
• Tegafur / gimeracil / oteracil ^IND

Darmziekten

• Etrolizumab

  • Moderately to severely active Crohn's disease

• Filgotinib

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

• Mirikizumab

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

• Ozanimod

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

• Risankizumab

  • Indicated for CD (ziekte van Crohn)

• Tenapanor

  • Irritable bowel syndrome with constipation

• Upadacitinib

  • Moderately to Severely Active Ulcerative Colitis
• Vedolizumab ^IND

Dementie

• Aducanumab

Depressie

• Bupropion/dextromethorphan

• Esketamine

  • Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant major depressive disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.
  • Extension of indication to include a new indication for SPRAVATO® (esketamine nasal spray) co-administered with oral antidepressant therapy in adults with a moderate to severe episode of Major Depressive Disorder (MDD), as acute short term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.
• Zuranolone

Diabetes

• Bexagliflozine

• Dapagliflozine

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

• Dasiglucagon

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

• Exenatide

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

• Finerenon

  • Delay progression of kidney disease, reduce the risk of cardiovascular mortality and morbidity.
• Polyethylene glycol loxenatide
• Reparixin

• Sotagliflozine

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

• Tirzepatide

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

Duchenne

• Golodirsen

Eierstokkanker

• Niraparib

  • As monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

Epilepsie

• Brivaracetam ^IND

• Cannabidiol

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

• Fenfluramine

  • Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome
  • Fintepla is indicated for the treatment of seizures associated with Dravet syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.
• Ganaxolone
• Lacosamide ^IND

Fungale infecties

• Ibrexafungerp

  • Patients with acute Vulvovaginal Candidiasis
• Oteseconazole

• Posaconazol

  • Extension of indication to include primary treatment of invasive aspergillosis in paediatric patients from 2 years of age weighing more than 40kg and adults for Noxafil gastroresistant tablet and concentrate for solution for infusion. Noxafil gastro-resistant tablets and solution are indicated for use in the treatment of the following fungal infections: Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products.
  • Extension of indication to include primary treatment of invasive aspergillosis in adults and adolescents from 13 years of age for Noxafil gastroresistant tablet and concentrate for solution for infusion.
• Rezafungin

HIV

• Atazanavir / cobicistat
• Cabotegravir
• Fostemsavir

• Lenacapavir

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

Hart- en vaatziekten

• Avacopan

Hematologie, overig

• Zanubrutinib

  • Patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or as first-line treatment for patients unsuitable for chemo-immunotherapy.

Hemostase bevorderende medicatie

• Eptacog alfa (activated)

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

Hersenkanker

• Autologous glioma tumor cell lysates
• Vocimagene amiretrorepvec

Hoofd- en halskanker

• Leukocyte interleukin

  • Head and neck (or upper airways tract) cancers, squamous cell - first-line.

• Pembrolizumab

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

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.
• Erenumab

• Fremanezumab

  • Indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.

• Galcanezumab

  • Emgality is geïndiceerd voor de profylaxe van migraine bij volwassenen die ten minste 4 dagen per maand migraine hebben.
• Lasmiditan
• Meloxicam / rizatriptan

• Rimegepant

  • Migraine Prevention

Huidkanker

• Cemiplimab

  • Libtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).
• Darleukin fibromun

• Lifileucel

  • Maliganant melanoma, advanced melanoma.

• Pembrolizumab

  • 1L treatment with pembrolizumab for advanced melanoma, in combination with lenvatinib.
  • Extension of indication to include the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, Stage IIC or stage III melanoma and to include the treatment of adolescents aged 12 years and older with advanced melanoma for Keytruda
• Relatlimab
• Seviprotimut-L
• Tavokinogene telseplasmid

Huidziekten

• Abrocitinib

  • Indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
• Beremagene geperpavec
• Berkenschorsextract

• Bimekizumab

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

• Deucravacitinib

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

• Lebrikizumab

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

• Risankizumab

  • Patients with Atopic Dermatitis 12 Years and older.

• Ruxolitinib

  • Treatment of non-segmental vitiligo

• Secukinumab

  • Hidradenitis Suppurativa (HS)

• Spesolimab

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

• Tapinarof

  • Adult Plaque Psoriasis
  • Atopische dermatitis
• Tirbanibulin

• Tralokinumab

  • Adtralza is indicated for treatment of moderate‑to‑severe atopic dermatitis in adult patients who are candidates for systemic therapy.

• Upadacitinib

  • Rinvoq is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

Infectieziekten, overig

• Fluticasone propionate

• Tixagevimab / cilgavimab

  • The prevention of COVID-19 in adults.

Leverkanker

• Durvalumab

  • In combination with tremelimumab in patients with HCC not eligible for locoregional therapy (1L).
  • Durvalumab (+/- bevacizumab) in combinatie met TACE in patiënten met locoregionale HCC.

• Lenvatinib

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

• Pembrolizumab

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

• Pemigatinib

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

• Tremelimumab

  • Durvalumab in combinatie met tremelimumab als eerste lijnsbehandeling bij unresectable HCC.

Leverziekten

• Cenicriviroc
• Givosiran

• Maralixibat

  • Treatment of cholestatic liver disease in patients with Alagille syndrome (ALGS) 1 year of age and older.
  • Progressive Familial Intrahepatic Cholestasis Type 2 Treatment of Progressive Familial Intrahepatic Cholestasis Type 2

• Obeticholic acid

  • Fibrosis due to Non-Alcoholic Steatohepatitis (NASH)

• Odevixibat

  • Treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older.
• Seladelpar

Lipidenverlagende medicatie

• Bempedoic acid

• Bempedoic acid / ezetimibe

  • Nustendi is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe, alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone or in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.

• Evinacumab

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

• Evolocumab

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

• Inclisiran

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

Long, overig

• Pirfenidone

  • Lichte tot matige idiopathische pulmonale fibrose (IPF) bij volwassenen.

Longkanker

• 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 for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a PD-L1 expression ≥ 50% tumour cells (TC) or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR mutant or ALK-positive NSCLC.
  • Extension of indication to include adjuvant treatment of non-small cell lung cancer (NSCLC) following resection and platinum-based chemotherapy for adult patients whose tumours have PD-L1 expression on ≥ 1% of tumour cells (TC).

• Avelumab

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

• Cemiplimab

  • Cemiplimab wordt onderzocht als eerstelijns behandeling in combinatie met chemotherapie voor volwassen patiënten met lokaal gevorderd of gemetastaseerde plaveiselcel en niet-plaveiselcel NSCLC (stadium IIIB/C-IV) onafhankelijk van PD-L1 expressie.
  • 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

  • Non-small cell lung cancer (NSCLC) stage IV, in combination with tremelimumab and chemo,1L.
  • 1L advanced NSCLC
  • Non-small cell lung cancer (NSCLC) stage IV, in combination with chemo, 1L.
  • Lokaal gevorderd, niet-resectabel NSCLC (stadium III)
  • Completely resected NSCLC
  • Imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
• Ensartinib

• Entrectinib

  • Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.

• Lorlatinib

  • Extension of indication to include the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.

• Lurbinectedin

  • Small cell lung cancer (SCLC)
• Mobocertinib

• Nivolumab

  • Opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.
• OSE-2101

• Osimertinib

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

• Pralsetinib

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

• Selpercatinib

  • Advanced RET fusion-positive non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
• Sotorasib
• Tepotinib

• Trastuzumab deruxtecan

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

• pembrolizumab

  • 1L Treatment with pembrolizumab for treatment-naïve adults with no prior systemic therapy for metastatic non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expresssion of TPS ≥1%, in combination with lenvatinib

Longziekten, overig

• Ambrisentan

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

• Benralizumab

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

• Mepolizumab

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

• Pirfenidone

  • Extension of indication to include the treatment of unclassifiable interstitial lung disease (UILD) for Esbrie.

Maagkanker

• Avapritinib

  • AYVAKYT is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) harbouring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation.

• Nivolumab

  • Extension of indication to use Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy, in first-line treatment of adult patients with advanced or metastatic gastric, gastro-oesophageal junction (GEJ) or oesophageal adenocarcinoma.
• Ripretinib
• Rivoceranib

• Trastuzumab deruxtecan

  • Extension of indication to include monotherapy treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior anti-HER2-based regimen
• Zolbetuximab

Multipel Myeloom

• Belantamab mafodotin

  • Blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
  • 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

  • Adult patients with relapsed or refractory multiple myeloma, whose prior regimens included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody and who had disease progression on the last regimen.​

• Daratumumab

  • Extension of indication to extend the existing therapeutic indication for daratumumab in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).
  • Multipel myeloom frontline behandeling in combinatie met VRd voor patiënten die niet in aanmerking komen voor een ASCT.
  • Darzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis.
  • In combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy.
  • Extension of indication to extend the existing therapeutic indication for daratumumab in combination with lenalidomide and dexamethasone (Rd) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

• 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.

• Lenalidomide

  • Revlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

• Melphalan flufenamide

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

• Pomalidomide

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

• Selinexor

  • Extension of indication for Nexpovio in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
  • Nexpovio is indicated in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
• Thalidomide ^G
• Zevorcabtagene autoleucel

Multiple sclerose

• Dimethyl fumarate

  • Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).
  • Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).
  • Extension of indication to include treatment of relapsing remitting multiple sclerosis (RRMS) in paediatrics patients from 10 years of age and over.
  • Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).
• Diroximel fumarate

• Natalizumab

  • TYSABRI is geïndiceerd als enkelvoudige ziekte modificerende therapie bij volwassenen met zeer actieve relapsing-remitting multiple sclerose in de volgende patiëntengroepen: • Patiënten met zeer actieve ziekte ondanks een volledige en adequate behandeling met ten minste één ziekte modificerende therapie (disease modifying therapy, DMT) of • Patiënten met zich snel ontwikkelende ernstige relapsing-remitting multiple sclerose, gedefinieerd door 2 of meer invaliderende relapses in één jaar, en met 1 of meer gadolinium aankleurende laesies op de hersen-MRI of een significante toename van de lading van T2-laesies in vergelijking met een eerdere recente MRI.
• Ofatumumab
• Ponesimod

• Teriflunomide

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

• Ublituximab

  • Relapsing multiple sclerosis

Myeloproliferatieve aandoeningen

• Fedratinib

  • Inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are JAK inhibitor naïve or who have been treated with ruxolitinib.
• Momelotinib
• Ropeginterferon alfa-2b

Neuro-endocriene kanker

• Selumetinib

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

Neurologie, overig

• Cannabidiol gel/intradermaal
• Eladocagene exuparvovec

• Inebilizumab

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

• Satralizumab

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

• Tiratricol

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

• Vutrisiran

  • Hereditary transthyretin-mediated amyloidosis.

Nierkanker

• Avelumab

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

• Cabozantinib

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

• Lenvatinib

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

• Pembrolizumab

  • Adjuvant treatment in monotherapy of adults with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
  • Extension of indication for Keytruda to include in combination with lenvatinib first line treatment of adults with advanced renal cell carcinoma (RCC).
• Tivozanib ^IND

Non-hodgkin lymfoom agressief

• Axicabtagene ciloleucel

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

• Crizotinib

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

• Ibrutinib

  • Mantle cell lymphoma (MCL), 1L.

• 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).

• Pirtobrutinib

  • Mantle Cell Lymphoma (MCL)

• 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).
• Tagraxofusp

• Zanubrutinib

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

• loncastuximab tesirine

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

Non-hodgkin lymfoom indolent

• Axicabtagene ciloleucel

  • Extension of indication to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.
• Copanlisib
• Hypericin

• Mosunetuzumab

  • Refractory follicular lymphoma (FL)
• Umbralisib

Onbekend

• Olopatadine / mometasone

Oncologie, overig

• 131I-omburtamab

• 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

  • Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer.

• Entrectinib

  • Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older, with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor or who have no satisfactory treatment options.
• Futibatinib
• Glucarpidase

• Ivosidenib

  • Cholangiocarcinoma in patients with an isocitrate dehydrogenase 1 (IDH1) mutation, whose disease has progressed after one or two systemic therapies.
• Larotrectinib

• Lenvatinib

  • Advanced or Recurrent Endometrial Cancer (1L) in combination with pembrolizumab
  • Extension of indication to include lenvatinib in combination with pembrolizumab for the treatment of adult patients with advanced endometrial carcinoma (EC) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation
• Lipegfilgrastim ^IND
• NY-ESO-1 autologous engineered TCR-T cells

• Nivolumab

  • Opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy
  • Extension of indication to include in combination with fluoropyrimidineand platinum-based combination chemotherapy the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) for OPDIVO.
  • Opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.

• Pembrolizumab

  • Extension of indication for Keytruda as monotherapy in the treatment of unresectable or metastatic MSI-H or dMMR colorectal, endometrial, gastric, small intestine, biliary, or pancreatic cancer in adults who have received prior therapy.
  • Extension of indication to include a new indication for Keytruda, in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent, or metastatic cervical cancer in adults.
  • 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.

• Retifanlimab

  • Patients With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma.

• Selinexor

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

• Tebentafusp

  • Advanced Uveal Melanoma

Oogaandoeningen

• Aflibercept

  • Retinopathy of prematurity
• Avacincaptad pegol
• Bevacizumab-vikg

• Brolucizumab

  • Extension of indication to include treatment of visual impairment due to DME for Beovu

• Faricimab

  • Treatment of neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DME).
• Lenadogene nolparvovec
• Netarsudil / latanoprost
• Perfluorohexyloctane
• Phentolamine

• Ranibizumab

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

• Reproxalap

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

Overige medicatie hart-en vaatziekten

• Allogenic immunomodulatory progenitor cells
• Angiotensin II
• Apabetalon

• Dapagliflozine

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

• Empagliflozine

  • Jardiance is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.
  • Chronic Heart Failure With Preserved Ejection Fraction (HFpEF, LVEF >40%).
• Etripamil
• Icosapent ethyl

• Macitentan

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

• Mavacamten

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

• Rilonacept

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

• Sotagliflozine

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

• Vericiguat

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

Overige niet-oncologische hematologische medicatie

• Avatrombopag

• Betibeglogene autotemcel

  • Zynteglo is geïndiceerd voor gebruik bij patiënten in de leeftijd van 12 jaar en ouder met transfusie-afhankelijke β-thalassemie (transfusion-dependent β-thalassaemia - TDT) die geen β0/β0-genotype hebben, voor wie transplantatie van hematopoëtische stamcellen (HSC) gepast is, maar geen humaan leukocytenantigeen (HLA)-compatibele gerelateerde HSC-donor beschikbaar is.
  • Behandeling van patiënten jonger dan 12 jaar met transfusie-afhankelijke β-thalassemie (TDT) die geen β0/β0-genotype hebben en voor wie hematopoïetische stamceltransplantatie (HSC) gepast is, maar voor wie geen humaan leukocyt antigeen (HLA)-compatibele verwante HSC-donor beschikbaar is.
  • Behandeling van patiënten met transfusie-afhankelijke β-thalassemie (TDT) die een β0 mutatie op beide allelen van het β-globuline (HBB) hebben en voor wie hematopoïetische stamceltransplantatie (HSC) gepast is, maar voor wie geen humaan leukocyt antigeen (HLA)-compatibele verwante HSC-donor beschikbaar is
• Crizanlizumab
• Daprodustat

• Efgartigimod

  • Idiopathic thrombocytopenic purpura (ITP)

• Eptacog alfa (activated)

  • Extension of indication to include treatment of severe postpartum haemorrhage
• Horse anti-human T lymphocyte immunoglobulin

• Hydroxycarbamide

  • Extension of indication to include treatment of severe chronic anemia (haemoglobin level <6 g/dL or <7 g/dL with poor clinical or functional tolerance) in adults, adolescents and children older than 2 years suffering from sickle cell syndrome.

• Luspatercept

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

• Mepolizumab

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

• Mitapivat

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

• Pegcetacoplan

  • Paroxysmal nocturnal haemoglobinuria (PNH)
• RP-L102

• Ravulizumab

  • 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.
  • Extension of indication to include treatment of paediatric patients with paroxysmal nocturnal haemoglobinuria (PNH) for Ultomiris (>10 kg).
• Roxadustat

• UM171

  • Patients With Sickle-Cell Disease
• Vadadustat
• Voxelotor

Parkinson

• Amantadine
• Istradefylline

• Levodopa / carbidopa

  • Parkinson

Pijn

• Bupivacaine extended release ^IND
• Fasinumab
• Lidocaïne
• Neridronic Acid
• SDN037

• Tanezumab

  • Treatment of moderate to severe chronic pain associated with OA of the hip or knee in adult patients for whom treatment with NSAIDs and/or any opioid is ineffective, not tolerated or inappropriate

Prostaatkanker

• Abiraterone

  • Geïndiceerd met prednison of prednisolon voor: - de behandeling van nieuw gediagnosticeerde hoog-risico gemetastaseerde hormoongevoelige prostaatkanker (mHSPC) bij volwassen mannen, in combinatie met androgeendeprivatietherapie (ADT); - de behandeling van gemetastaseerde castratieresistente prostaatkanker (mCRPC) bij volwassen mannen die asymptomatisch of licht symptomatisch zijn na falen van androgeendeprivatietherapie en voor wie behandeling met chemotherapie nog niet klinisch geïndiceerd is; - de behandeling van mCRPC bij volwassen mannen bij wie de ziekte progressief was tijdens of na een chemotherapieschema op basis van docetaxel.
  • Geïndiceerd met prednison of prednisolon voor: - de behandeling van nieuw gediagnosticeerde hoog-risico gemetastaseerde hormoongevoelige prostaatkanker (mHSPC) bij volwassen mannen, in combinatie met androgeendeprivatietherapie (ADT). - de behandeling van gemetastaseerde castratieresistente prostaatkanker (mCRPC) bij volwassen mannen die asymptomatisch of licht symptomatisch zijn na falen van androgeendeprivatietherapie en voor wie behandeling met chemotherapie nog niet klinisch geïndiceerd is. - de behandeling van mCRPC bij volwassen mannen bij wie de ziekte progressief was tijdens of na een chemotherapieschema op basis van docetaxel.
• DCVAC

• Darolutamide

  • Nubeqa is indicated for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.
  • Adult men with metastatic hormone senstive prostate cancer (mHSPC) in combination with docetaxel en ADT.

• Degarelix

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

• Enzalutamide

  • The treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
• Gozetotide

• Lutetium (177lu) vipivotide tetraxetan

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

• Masitinib

  • Metastatic Castration-resistant Prostate Cancer
• Niraparib / abiraterone

• Olaparib

  • Treatment in combination with abiraterone acetate in patients with metastatic Castration-resistant Prostate Cancer (mCRPC) who have not received prior chemotherapy or new hormonal agents (NHAs) for metastatic castration-resistant prostate cancer (mCRPC) (first-line setting).

• Pembrolizumab

  • 3L treatment of metastatic castration-resistant prostate cancer (mCRPC), after NHa and chemotherapy treatment (extensively pretreated mCRPC )  combined with Olaparib

• Relugolix

  • Treatment of adult patients with advanced prostate cancer.

• 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).

Psychiatrie, overig

• Dexmedetomidine

  • Agitation in Schizophrenia, Bipolar Disorder

Reuma

• Anifrolumab

  • Indicated as an add-on therapy for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), despite standard therapy.
• Cyclobenzaprine hydrochloride

• Risankizumab

  • Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).

• Sarilumab

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

• Secukinumab

  • Extension of indication to include treatment of Juvenile Idiopathic Arthritis (EnthesitisRelated Arthritis and Juvenile Psoriatic Arthritis) in patients 2 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy for Cosentyx.

• Tofacitinib

  • Extension of indication for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.
  • Tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive or negative polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs. Tofacitinib can be given in combination with methotrexate (MTX) or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.

SMA

• Onasemnogene abeparvovec

  • Patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type 1, or patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to 3 copies of the SMN2 gene.

• Risdiplam

  • 5q SMA in patients 2 months of age and older, with a clinical diagnosis of Type 1, Type 2 or Type 3 SMA or with one to four SMN2 copies.

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

• Selpercatinib

  • Patients With RET-Mutant Medullary Thyroid Cancer.
  • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Schizofrenie, psychose, bipolaire stoornis

• Lumateperone

Slaapstoornissen

• Daridorexant
• JZP-258
• Natriumoxybaat controlled release

• Pitolisant

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

Spierziekten, overig

• Amifampridine ^G
• Bidridistrogene xeboparvovec

• Sugammadex

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

Stamceltransplantaties

• Inolimomab
• Motixafortide
• Narsoplimab
• Omidubicel

• Remestemcel-L

  • Acute steroid-refractory graft versus host disease (GvHD) in adults and children - second-line following allogeneic bone marrow transplant (BMT).

• Ruxolitinib

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

• Tisagenlecleucel-T

  • Extension of indication for Kymriah, to include treatment of adult patients with follicular lymphoma (FL) after two or more lines of therapy who are refractory, or relapsed during or within 6 months after completion of anti -CD20 antibody maintenance, or relapsed after autologous haematopoietic stem cell transplantation (HSCT) .

• autologous anti-CD19-transduced CD3+ cells

  • 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.

Stofwisseling en Endocrinologie, overig

• 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

• Dapagliflozine

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

• Empagliflozine

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

• Linzagolix

  • For the management of heavy menstrual bleeding (HMB) associated with uterine fibroids.
• Lonapegsomatropin
• Lumasiran
• Osilodrostat
• Ospemifene

• Relugolix

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

• Semaglutide

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

• Somapacitan

  • Sogroya is indicated for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (AGHD).
• Spheroids of human autologous matrix-associated chondrocytes ^IND

• Vosoritide

  • Anticipated indication is the treatment of achondroplasia for children.

Stofwisselingsziekten

• Arimoclomol

  • Treatment of Niemann-Pick disease type C (NPC).
• Autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene
• Avalglucosidase alfa
• Bardoxolone Methyl
• Betaine ^G
• Cipaglucosidase alfa / Miglustat

• Elamipretide

  • Barth syndrome
• Elivaldogene autotemcel
• Fexapotide
• Fosdenopterin

• Hydrocortison

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

• Liraglutide

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

• Lonafarnib

  • Hutchinson-Gilford Progeria Syndrome and Progeroid Laminopathies.

• Migalastat

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

• Octreotide

  • Acromegalie
• Olenasufligene relduparvovec
• Olipudase alfa
• Palovarotene
• Pegunigalsidase alfa

• Pegvaliase

  • Palynziq is geïndiceerd voor de behandeling van patiënten met fenylketonurie (PKU) van 16 jaar en ouder met onvoldoende onder controle gebrachte fenylalanineconcentraties in het bloed (concentraties fenylalanine in het bloed hoger dan 600micromol/l) ondanks voorgaande behandeling met beschikbare behandelopties.
• Reloxaliase
• Sapropterin ^G

• Somatrogon

  • Somatrogon is indicated for the long-term treatment of children with growth disturbance due to insufficient secretion of growth hormone.

• Sparsentan

  • Focal Segmental Glomerulosclerosis

• Tenapanor

  • Hyperphosphatemia
• Trientine
• Triheptanoin
• Veverimer

Taaislijmziekte

• Elexacaftor / tezacaftor / ivacaftor

  • Kaftrio is indicated in a combination regimen with ivacaftor 150mg tablets for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
  • Kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene

• Ivacaftor

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

• Tezacaftor / ivacaftor

  • Symkevi is indicated in a combination regimen with ivacaftor 150mg tablets for the treatment of patients with cystic fibrosis (CF) aged 6 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272‑26A→G, and 3849+10kbC→T.

Virale infecties, overig

• Baloxavir marboxil

  • Treatment of influenza: Xofluza is indicated for the treatment of uncomplicated influenza in patients aged 12 years and above. Post‑exposure prophylaxis of influenza Xofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 12 years and above. Xofluza should be used in accordance with official recommendations.
• 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.
• Doravirine / ​lamivudine / ​tenofovirdisoproxil ^IND
• Elbasvir / grazoprevir ^IND

• Glecaprevir / pibrentasvir

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

• Lonafarnib

  • Hepatitis D infection with ritonavir
• Maribavir

• Nirsevimab

  • Respiratory syncytial virus infection prevention in Immunocompromised newborns and infants ≤ 24 months.
• Sofosbuvir / velpatasvir / voxilaprevi ^IND
• Tecovirimat
• sofosbuvir / velpatasvir ^IND