Published on 10 June 2020

ADHD

• Lisdexamfetamine

  • Patiënten van 18 jaar en ouder met ADHD die voor hun 18e levensjaar bekend waren met klachten van ADHD.
• Molindone

ALL

• Blinatumomab

  • Extension of indication to include the treatment of Philadelphia chromosome positive CD19 positive B-cell precursor acute lymphoblastic leukaemia (ALL) in adult and paediatric patients with relapsed or refractory ALL and adult patients in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%

• 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.

ALS

• Arimoclomol

  • Amyotropic Lateral Sclerosis
• Ibudilast

AML / MDS

• Arseentrioxide

  • Geïndiceerd voor het induceren van remissie en consolidatie bij volwassen patiënten met: 1) nieuw gediagnosticeerde acute promyelocytaire leukemie (APL) met laag tot middelmatig risico (aantal witte bloedcellen ≤ 10 x 103/μl) in combinatie met all-trans-retinoïnezuur (ATRA), 2) recidiverende/refractaire acute promyelocytaire leukemie (APL) (tijdens een eerdere behandeling moet een retinoïde stof zijn toegediend en chemotherapie hebben plaatsgehad), gekenmerkt door de aanwezigheid van de translocatie t(15;17) en/of de aanwezigheid van het gen promyeolocitaire-leukemie-/retinoïnezuurreceptor-alfa (PML/RAR-alfa).
  • Geïndiceerd voor het induceren van remissie en consolidatie bij volwassen patiënten met: 1) nieuw gediagnosticeerde acute promyelocytaire leukemie (APL) met laag tot middelmatig risico (aantal witte bloedcellen ≤ 10 x 103/μl) in combinatie met all-trans-retinoïnezuur (ATRA), 2) recidiverende/refractaire acute promyelocytaire leukemie (APL) (tijdens een eerdere behandeling moet een retinoïde stof zijn toegediend en chemotherapie hebben plaatsgehad), gekenmerkt door de aanwezigheid van de translocatie t(15;17) en/of de aanwezigheid van het gen promyeolocitaire-leukemie-/retinoïnezuurreceptor-alfa (PML/RAR-alfa).
  • Geïndiceerd voor het induceren van remissie en consolidatie bij volwassen patiënten met: 1) nieuw gediagnosticeerde acute promyelocytaire leukemie (APL) met laag tot middelmatig risico (aantal witte bloedcellen ≤ 10 x 103/μl) in combinatie met all-trans-retinoïnezuur (ATRA), 2) recidiverende/refractaire acute promyelocytaire leukemie (APL) (tijdens een eerdere behandeling moet een retinoïde stof zijn toegediend en chemotherapie hebben plaatsgehad), gekenmerkt door de aanwezigheid van de translocatie t(15;17) en/of de aanwezigheid van het gen promyeolocitaire-leukemie-/retinoïnezuurreceptor-alfa (PML/RAR-alfa).

• Azacitidine

  • Geïndiceerd voor de behandeling van volwassen patiënten die niet in aanmerking komen voor hematopoëtische stamceltransplantatie (HSCT), met: • intermediair 2 en hoog risico myelodysplastische syndromen (MDS) volgens het International Prognostic Scoring System (IPSS), • chronische myelomonocytaire leukemie (CMML) met 10-29% beenmergblasten zonder myeloproliferatieve aandoening, • acute myeloïde leukemie (AML) met 20-30% blasten en multilineaire dysplasie, volgens de indeling van de Wereldgezondheidsorganisatie (WHO). • AML met >30% beenmergblasten volgens de indeling van de WHO.
  • Geïndiceerd voor de behandeling van volwassen patiënten die niet in aanmerking komen voor hematopoëtische stamceltransplantatie (HSCT), met: • intermediair 2 en hoog risico myelodysplastische syndromen (MDS) volgens het International Prognostic Scoring System (IPSS), • chronische myelomonocytaire leukemie (CMML) met 10-29% beenmergblasten zonder myeloproliferatieve aandoening, • acute myeloïde leukemie (AML) met 20-30% blasten en multilineaire dysplasie, volgens de indeling van de Wereldgezondheidsorganisatie (WHO). • AML met >30% beenmergblasten volgens de indeling van de WHO.
  • AML post-intensive chemotherapy maintenance therapy for patients in complete remission
  • Geïndiceerd voor de behandeling van volwassen patiënten die niet in aanmerking komen voor hematopoëtische stamceltransplantatie (HSCT), met: • intermediair 2 en hoog risico myelodysplastische syndromen (MDS) volgens het International Prognostic Scoring System (IPSS), • chronische myelomonocytaire leukemie (CMML) met 10-29% beenmergblasten zonder myeloproliferatieve aandoening, • acute myeloïde leukemie (AML) met 20-30% blasten en multilineaire dysplasie, volgens de indeling van de Wereldgezondheidsorganisatie (WHO). • AML met >30% beenmergblasten volgens de indeling van de WHO.
• Enasidenib

• Gilteritinib

  • Xospata is geïndiceerd als monotherapie voor de behandeling van volwassen patiënten die gerecidiveerde of refractaire acute myeloïde leukemie (AML) met een FLT3-mutatie hebben.
• Glasdegib
• Idasanutlin
• Imetelstat
• Iomab-B

• Ivosidenib

  • Acute myeloid leukaemia (AML), isocitrate dehydrogenase-1 (IDH1) mutation - first-line combination therapy.
  • Relapsed or refractory isocitrate dehydrogenase-1 (IDH-1) mutation-positive acute myeloid leukaemia

• Luspatercept

  • Treatment of adult patients with transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy and for the treatment of adult patients with transfusion-dependent anaemia associated with beta-thalassaemia.
• Sapacitabine

• Venetoclax

  • Venetoclax in combination with azacitidine is indicated for the treatment-naive patients with AML who are ineligible for intensive chemotherapy.

Aggressive non-Hodgkin’s lymphoma

• Brentuximab vedotin

  • Adcetris in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL).

• Lisocabtagene maraleucel

  • Recidief DLBCL na ASCT of niet in aanmerking komend voor ASCT.
• Mogamulizumab

• Polatuzumab vedotin

  • Polivy in combinatie met bendamustine en rituximab is geïndiceerd voor de behandeling van eerder behandelde volwassen patiënten met diffuus grootcellig B-cellymfoom (DLBCL) die niet in aanmerking komen voor hematopoëtische stamceltransplantatie.

• Rituximab

  • Advanced stage paediatric B-cell Non-Hodgkin’s Lymphoma (B-NHL)

• Tafasitamab

  • is indicated in combination with lenalidomide followed by monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT).
• Tagraxofusp

• Zanubrutinib

  • Mantelcel non-hodgkin lymfoom Waldenström's macroglobulinaemia (WM) Chronische Lymfatische Leukemie (CLL)
  • Mantle-cell lymphoma

Allergy

• Arachis hypogaea (pinda) allergenen (capsule)
• Arachis hypogaea (pinda) allergenen (pleister)
• Olopatadine / mometasone

• Omalizumab

  • Adjunct Therapy to Multi-Allergen OIT in Food Allergic Patients.

Antithrombotic medications

• Andexanet alfa

• Apixaban

  • Pevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

• Ravulizumab

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

Asthma

• Beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium

  • Maintenance treatment in adult patients with asthma who are not adequately treated by ICS/LABA or who are already treated with ICS/LABA/LAMA.
• Fevipiprant

• Fluticasone furoate / umeclidinium / vilanterol

  • Asthma in adults inadequately controlled with dual steroid/beta agonist therapy
• Indacaterol acetate/glycopyrronium bromide/mometasone furoate
• Indacaterol acetate/mometasone furoate

• Masitinib

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

• Omalizumab

  • Aanvullende behandeling om de astmacontrole te verbeteren bij patiënten met ernstig persistent allergisch astma. Ook voor de behandeling van chronische idiopathische urticaria.
  • Aanvullende behandeling om de astmacontrole te verbeteren bij patiënten met ernstig persistent allergisch astma.
  • Aanvullende behandeling om de astmacontrole te verbeteren bij patiënten met ernstig persistent allergisch astma.

Bacterial infections

• Amoxicilline / omeprazol / rifabutin

• Bedaquiline

  • Sirturo is indicated for use as part of an appropriate combination regimen for pulmonary multidrug‑resistant tuberculosis (MDR‑TB) in adults and adolescent patients (12 years to less than 18 years of age and weighing at least 30 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
• Cefiderocol

• Ceftaroline fosamil

  • Extension of indication for the treatment of community acquired pneumonia (CAP) to include concurrent bacteraemia due to Streptococcus pneumoniae (SP) for all age groups.
  • Indicatieuitbreiding voor de behandeling van kinderen jonger dan twee maanden voor gecompliceerde infecties van de huid en van de weke delen (Complicated Skin and Soft Tissue Infection, cSSTI) en buiten het ziekenhuis opgelopen pneumonie (Community-acquired pneumonia, CAP).

• Ceftazidime / avibactam

  • Extension of indication to include bacteraemia (in association with, or suspected to be associated with, the currently approved indications for complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI) and hospital-acquired pneumonia, including ventilator-associated pneumonia.
  • Extension of the complicated intra-abdominal infection (cIAI) and complicated urinary tract infection (cUTI) indications in paediatric patients (in children ≥ 3 months).
• Ceftolozaan / tazobactam ^IND

• Delafloxacin

  • Extension of indication to include treatment of Community Acquired Pneumonia (CAP) for Quofenix 450 mg tablets and 300 mg powder for concentrate for solution for infusion.
  • Quofenix is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
• Iclaprim

• Imipenem / cilastatin / relebactam

  • Recarbrio is indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.
• Lefamulin
• Liposomaal amikacine
• Obiltoxaximab
• Ozenoxacine
• Plazomicin

• Pretomanid

  • Pretomanid FGK is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (XDR), or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).

• Tedizolid

  • Hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), complex bacterial infections, caused by gram positive pathogens
• Tigecycline ^G

Bipolar disorder

• Lumateperone

• Lurasidone

  • Bipolar depression, as monotherapy and adjunct treatment.

Bladder cancer

• Atezolizumab

  • Adjuvant treatment after surgical resection of high-risk muscle-invasive bladder cancer (MIBC).
  • Tecentriq is als monotherapie geïndiceerd voor de behandeling van volwassen patiënten met lokaal gevorderd of gemetastaseerd urotheelcarcinoom (UC) na eerdere behandeling met platina-bevattende chemotherapie of voor wie cisplatine ongeschikt is.
  • Extension of indication to include, in combination with platinum-based chemotherapy, first-line treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) for Tecentriq.

• Avelumab

  • First line treatment of locally advanced or metastatic urothelial carcinoma (UC).

• Durvalumab

  • First line bladder cancer.

• 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
• Oportuzumab monatox

• Pembrolizumab

  • 1L bladder carcinoma stage III/IV, including cisplatin-eligible.

• Tremelimumab

  • First line bladder cancer i.c.m. durvalumab

Bowel diseases

• Adalimumab

  • Colitis ulcerosa treatment in pediatrics (4 Years to 17 Years)

• Alicaforsen

  • Ulcerative colitis
  • Pouchitis

• Remestemcel-L

  • Ziekte van Crohn

• Tenapanor

  • Irritable bowel syndrome with constipation

Brain cancer

• Asunercept
• Brain cancer vaccine
• ERC1671
• Vocimagene amiretrorepvec

Breast cancer

• Abemaciclib

  • Patients with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.

• Alpelisib

  • Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.

• Atezolizumab

  • treatment of patients with previously untreated metastatic TNBC in combination with paclitaxel
  • Neoadjuvant treatment for patients with early TNBC in combination with nab-paclitaxel.
• Margetuximab

• Neratinib

  • Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.

• Paclitaxel

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

• Pembrolizumab

  • Breast cancer, metastatic, triple negative, 1L.
  • Triple Negative Breast Cancer - Neoadjuvant
• Pertuzumab / trastuzumab ^IND

• Sacituzumab govitecan

  • Relapsed/refractory triple-negative breast cancer (TNBC)

• Talazoparib

  • Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.

• Trastuzumab deruxtecan

  • Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 therapies.
• Trastuzumab duocarmazine

• Trastuzumab emtansine

  • Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.
  • Trastuzumab entansine in combination with pertuzumab following anthracyclines as adjuvant therapy in patients with operable HER2-positive primary breast cancer.

• Tucatinib

  • Behandeling van HER2 positieve borstkanker in combinatie met Capecitabine en Trastuzumab (2L+)

• Veliparib

  • Breast cancer; HER2-negative metastatic or locally advanced unresectable BRCA-associated - first to third-line in combination with carboplatin and paclitaxel.

CLL

• Acalabrutinib

  • Behandeling van relapsed/refractory CLL (chronic lymphocytic leukemia).
  • 1L CLL in combinatie met obinutuzumab
• Duvelisib

• Ibrutinib

  • Extension of indication to the existing chronic lymphocytic leukaemia (CLL) indication to include combination use with obinutuzumab for the treatment of adult patients with previously untreated CLL.
• Moxetumomab pasudotox

• Venetoclax

  • Venclyxto in combinatie met rituximab is geïndiceerd voor de behandeling van volwassen patiënten met chronische lymfatische leukemie (CLL) die ten minste één andere therapie hebben gehad.
  • Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

COPD

• Formoterol / glycopyronium / budesonide

  • Chronic Obstructive Pulmonary Disease
• Formoterol/glycopyronium
• Revefenacin

Cardiovascular diseases

• Rituximab

  • MabThera, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥2 to <18 years old) with severe, active GPA (Wegener’s) and MPA.
• Sutimlimab

Colon cancer

• Eflornithine / sulindac

• Encorafenib

  • Extension of indication to include encorafenib in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy. 3L

Cystic fibrosis

• Bamocaftor / tezacaftor / ivacaftor

• Elexacaftor / tezacaftor / ivacaftor

  • For CF patients age 12 years and older who are - homozygous for the F508del mutation in the CFTR gene - heterozygous for F508del and a minimal function mutation in the CFTR gene

• Ivacaftor

  • Kalydeco tablets are indicated for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R .
  • Kalydeco granules are indicated for the treatment of infants aged at least 6 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (CF) who have one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R (see sections 4.4 and 5.1)

• Lumacaftor / ivacaftor

  • Cystische fibrose voor kinderen van 2 tot 5 jaar oud die homozygoot zijn voor de F508del CFTR genmutatie

• Tezacaftor / ivacaftor

  • Cystische fibrose voor patiënten van 6 tot en met 11 jaar met met een dubbele F508del-mutatie of één F508del plus één van de volgende 14 mutaties: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, 3849+10kbC→T.
  • Symkevi is indicated in a combination regimen with ivacaftor 150 mg tablets for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T.

Dementia

• Aducanumab

• Leuco-methylthioninium

  • Dementia, behavioural variant frontotemporal.
  • Alzheimer’s disease, mild-to-moderate.

Depression

• Brexanolone

• Esketamine

  • Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant major depressive disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.
  • Extension of indication to include a new indication for Spravato for the rapid reduction of depressive symptoms in adult patients with a moderate to severe depressive episode of MDD who have current suicidal ideation with intent.
• Zuranolone

Diabetes

• Canagliflozine

  • Invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications and in addition to other medicinal products for the treatment of diabetes
• Canagliflozine / metformine ^IND
• Dapagliflozin / saxagliptin / metformin

• Dapagliflozine

  • Extension of Indication to include type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.

• Dasiglucagon

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

• Empagliflozine

  • diabetes mellitus type 1, adjunct to insulin

• Exenatide

  • Diabetes type 2
• Finerenone

• Glucagon

  • Behandeling van ernstige hypoglykemie bij volwassenen, adolescenten en kinderen in de leeftijd van 4 jaar en ouder met diabetes mellitus.

• Insulin aspart

  • The treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
  • The treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
• Insulin glargine ^IND
• Insulin lispro (ultra rapid formulation)
• Insuline voor inhalatie

• Liraglutide

  • Extension of Indication to include treatment of children and adolescents (age 10-17 years) with type 2 diabetes.
• Polyethylene glycol loxenatide
• Reparixin

• Semaglutide

  • Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications or in combination with other medicinal products for the treatment of diabetes.

• Sotagliflozine

  • Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control
  • Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy.

Duchenne

• Edasalonexent

• Idebenone

  • Treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) not using glucocorticoids.

Epilepsy

• Cannabidiol

  • Indicated for use as adjunctive therapy of seizures associated with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older.
  • Seizures in Tuberous Sclerosis Complex.
• Cenobamate

• Fenfluramine

  • Seizures associated with Dravet syndrome (first-line, low-dose formulation)
• Perampanel ^IND
• Vigabatrin

Eye disorders

• Abicipar

• Aflibercept

  • Diabetic macular edema
• Aganirsen

• Brolucizumab

  • Treatment of neovascular (wet) age-related macular degeneration (AMD)
  • Diabetic Macular Edema (DME)

• Ciclosporin

  • Treatment of severe vernal keratoconjunctivitis in children from 4 years of age and adolescents.
• Latanoprostene bunod
• Lenadogene nolparvovec
• Lifitegrast
• Netarsudil / latanoprost
• Netarsudil mesylate
• Polihexanide

• 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).

• Reproxalap

  • Allergic conjunctivitis
• Tivanisiran
• Voretigene neparvovec

Head and neck cancer

• Afatinib ^IND

• Avelumab

  • Definitive Treatment In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck
• Brilacidin

• Durvalumab

  • Squamous cell carcinoma of the head and neck, 1L PDL 1

• Leukocyte interleukin

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

• Pembrolizumab

  • Keytruda, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a CPS ≥ 1.

• Tremelimumab

  • Squamous cell carcinoma of the head and neck, 1L PDL 1 in combination with durvalumab

Headache

• Eptinezumab

  • Migraine profylaxe van 'frequent episodic migraine' (EM) en 'chronic migraine' (CM).
• Erenumab

• Fremanezumab

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

• Galcanezumab

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

Hearing disorders

• Brimapitide
• Pioglitazone

Hemostasis promoting medication

• Emicizumab

  • Hemlibra is geïndiceerd voor de routinematige profylaxe van bloedingen bij patiënten met hemofilie A zonder remmers tegen factor VIII.
• Entranacogene dezaparvovec
• Eptacog beta (activated)
• Fibrinogen
• Fidanacogene elaparvovec

• Turoctocog alfa pegol

  • Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).
• Valoctocogene roxaparvovec

Hormonal disorders

• Levoketoconazole
• Macimorelin

• Octreotide

  • Acromegalie
• Osilodrostat

• Somapacitan

  • Growth hormone deficiency in adults and pre-pubertal children

• Tenapanor

  • Hyperphosphatemia
• TransCon Growth Hormone

Indolent non-Hodgkin’s lymphoma

• Axicabtagene ciloleucel

  • Recidiverend of refractair na 2 of meer lijnen van therapie iNHL (alleen FL en MZL).
• Copanlisib

• Ibrutinib

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

• Lenalidomide

  • Revlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).
• Umbralisib

Infectious diseases other

• Anidulafungin ^IND

• Ibrexafungerp

  • Patients with acute Vulvovaginal Candidiasis

• Posaconazole

  • Posaconazole AHCL is indicated for treatment of the following fungal infections in adults: - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. - Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Posaconazole AHCL is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
  • Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults: - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Posaconazole Accord is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
• Rezafungin

Kidney cancer

• Avelumab

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

• Ipilimumab

  • Yervoy is in combinatie met nivolumab geïndiceerd voor de eerstelijnsbehandeling van gevorderd niercelcarcinoom met intermediair/ongunstig risicoprofiel bij volwassenen.

• Pembrolizumab

  • Keytruda, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma (RCC) in adults.
• Tivozanib ^IND

Leukemia

• Asciminib

  • Philadelphia chromosoom positieve (Ph+) Chronische Myeloïde Leukemie (CML) in 3e lijn.

Lipid-lowering medications

• Alirocumab

  • Indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: • in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
• 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.

• Inclisiran

  • Hypercholesterolaemia, elevated LDL-cholesterol (LDL-C) despite maximum tolerated doses of LDL-C lowering therapies.

• Volanesorsen

  • Waylivra is geïndiceerd als een aanvulling op het dieet bij volwassen patiënten met genetisch bevestigd familiair chylomicronemiesyndroom (FCS) met een hoog risico van pancreatitis bij wie de respons op dieet en triglyceridenverlagende behandeling onvoldoende was.

Liver cancer

• Atezolizumab

  • Extension of indication to include, in combination with bevacizumab, the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

• Pemigatinib

  • Treatment of locally advanced or metastatic cholangiocarcinoma relapsed or refractory after at least one line of systemic therapy.

Liver diseases

• Givosiran

• Obeticholic acid

  • Fibrosis due to Non-Alcoholic Steatohepatitis (NASH)

• Odevixibat

  • Treatment of Progressive Familial Intrahepatic Cholestasis
• Seladelpar

Lung cancer

• Atezolizumab

  • For the 1L treatment of patients with metastatic, squamous NSCLC in combination with chemotherapy
  • Extension of indication to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours express PD-L1.

• Avelumab

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

• Brigatinib

  • Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor

• Canakinumab

  • Gevorderd niet-kleincellig longcarcinoom, als toevoeging aan pembrolizumab en chemotherapie
• Dacomitinib

• Durvalumab

  • Non-small cell lung cancer (NSCLC) stage IV, in combination with chemo, 1L.
  • Extension of indication to include the use of IMFINZI in combination with etoposide and either carboplatin or cisplatin for the first-linetreatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

• 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

  • Lorlatinib as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or crizotinib and at least one other ALK TKI.

• Lurbinectedin

  • Small cell lung cancer (SCLC)

• Nivolumab

  • Extension of Indication to include first-line treatment of adult patients with metastatic Non-Small Cell Lung Carcinoma (NSCLC) in combination with ipilimumab.

• Osimertinib

  • First-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.

• Pembrolizumab

  • Pembrolizumab in Combination with Etoposide/Platinum (Cisplatin or Carboplatin) for the treatmen of extensive stage Small Cell Lung Cancer (SCLC) (1L)
  • Extension of Indication to include 1st line treatment of locally advanced or metastatic non-small cell lung cancer tumours expressing PD-L1 with a ≥ 1% tumour proportion score (TPS).

• Ramucirumab

  • Cyramza in combination with erlotinib is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) mutations.

• Selpercatinib

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

• Tremelimumab

  • Non-small cell lung cancer (NSCLC) stage IV, in combination with durvalumab and chemo, 1L.
  • Untreated extensive-stage small cell lung cancer (SCLC) in combination with durvalumab and chemotherapy.

Lung other

• Ambrisentan

  • Behandeling van pulmonale arteriële hypertensie (PAH) bij volwassen patiënten geclassificeerd als WHO functionele klasse (FC) II of III, waaronder gebruik in een combinatietherapie.
  • Behandeling van pulmonale arteriële hypertensie (PAH) bij volwassen patiënten geclassificeerd als WHO functionele klasse (FC) II of III, waaronder gebruik in een combinatietherapie.

• 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.

• Dupilumab

  • Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.

• Mepolizumab

  • Eosinofile granulomatueze poly angiitis (EGPA) (voorheen Churg Strauss syndroom).
• Molgramostim

• Nintedanib

  • Ofev is indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases with a progressive phenotype.
  • Ofev is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease.

• Omalizumab

  • Extension of indication to include treatment of nasal polyps in adult patients with inadequate response to intranasal corticosteroids.
• Sarizotan
• Selexipag

Mesothelioma

• Nivolumab

  • Mesothelioom (in combinatie met ipilimumab).

Metabolic diseases

• Arimoclomol citraat
• Asfotase alfa
• 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
• Autologous CD34+ haematopoietic stem cells (HSCs) transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA
• Avalglucosidase alfa

• Burosumab

  • Extension of indication to include treatment of adults with X-linked hypophosphataemia (XLH), and modification of the currently approved indication in children and adolescents, by removing the qualification ‘with growing skeletons’, in order to include treatment in all children with radiographic evidence of bone disease.
• Chenodeoxycholzuur
• Kaliumcitraat / kaliumwaterstofcarbonaat

• Lonafarnib

  • Hutchinson-Gilford Progeria Syndrome and Progeroid Laminopathies.
• Metreleptin
• Nitisinone ^IND
• Olipudase 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 600 micromol/l) ondanks voorgaande behandeling met beschikbare behandelopties.
• Reloxaliase
• Trientine
• Vestronidase alfa
• Veverimer

• Volanesorsen

  • Familial Partial Lipodystrophy

Multiple Myeloma

• Belantamab mafodotin

  • Patients With Multiple Myeloma Who Had 3 or More Prior Lines of Treatment, Are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed an Anti-CD38 Antibody

• Carfilzomib

  • Combinatie van carfilzomib met daratumumab en dexamethason (KdD) bij patienten met multipel myeloom die tenminste één eerdere lijn van behandeling hebben gehad.

• 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).
  • Subcutaneous formulation indicates for Relapsed or Refractory Multiple Myeloma
  • Amyloidose eerstelijnsbehandeling in combinatie met bortezomib, cyclofosfamide en dexamethason
  • In combinatie met pomalidomide en dexamethason voor patiënten met multipel myeloom die tenminste een eerdere lijn van behandeling hebben gehad.
  • 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).

• Ibrutinib

  • Extension of indication to include treatment of adult patients with Waldenström's macroglobulinaemia (WM) in combination with rituximab.

• Idecabtagene vicleucel

  • Multiple Myeloom Relapsed and Refractory

• Isatuximab

  • Combinatie van isatuximab met carfilzomib en dexamethason bij patiënten met gerecidiveerd en refractair multipel myeloom na 1 tot maximaal 3 eerdere behandellijnen.
  • Sarclisa is indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) and have demonstrated disease progression on the last therapy.

• Ixazomib

  • Non-ASCT maintenance  Multiple Myeloma (MM)
  • Newly diagnosed Multiple Myeloma (MM)

• 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.

• 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

  • Patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy and whose disease is refractory to at least one PI, one IMiD, and one anti-CD38 monoclonal antibody, and to their most recent treatment regimen.

Multiple sclerosis

• Fampridine ^G

• Fingolimod

  • Enkelvoudige ziekte modificerende therapie bij zeer actieve relapsing remitting multiple sclerose in de volgende groepen van volwassen patiënten en pediatrische patiënten van 10 jaar en ouder: -Patiënten met zeer actieve ziekte ondanks een volledige en adequate behandeling met ten minste één ziekte modificerend middel. -Patiënten met zich snel ontwikkelende ernstige relapsing/remitting multiple sclerose, gedefinieerd door 2 of meer invaliderende schubs 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.
  • Enkelvoudige ziekte modificerende therapie bij zeer actieve relapsing remitting multiple sclerose in de volgende groepen van volwassen patiënten en pediatrische patiënten van 10 jaar en ouder: -Patiënten met zeer actieve ziekte ondanks een volledige en adequate behandeling met ten minste één ziekte modificerend middel. -Patiënten met zich snel ontwikkelende ernstige relapsing/remitting multiple sclerose, gedefinieerd door 2 of meer invaliderende schubs 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.

• Masitinib

  • Multiple sclerosis, primary-progressive or relapse-free secondary progressive
• Ofatumumab ^IND

• Ozanimod

  • Adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.
• Ponesimod
• Siponimod

• Teriflunomide

  • Multiple sclerosis bij kinderen en adolescenten van 10 jaar en ouder.

Muscular diseases other

• Mexiletine HCl

Myeloproliferative disorders

• Fedratinib

  • Myelofibrosis
• Ropeginterferon alfa-2b

Neuroendocrine cancer

• L-lysine / L-arginine

• Selumetinib

  • Paedriatric (12-18 years of age) neurofibromatosis type-1.
• Surufatinib

Neurological disorders other

• Botulinum A toxin

  • Nuceiva is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.

• Buprenorphine

  • Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.

• Dexmedetomidine

  • Voor sedatie van volwassen IZ-patiënten (Intensieve Zorgpatiënten) bij wie het noodzakelijk is dat de diepte van het sedatieniveau het nog mogelijk maakt de patiënt met een verbale prikkel te wekken (overeenkomend met Richmond Agitation-Sedation Scale (RASS) 0 tot -3). Voor sedatie van niet-geïntubeerde volwassen patiënten voor en/of tijdens diagnostische of chirurgische procedures die sedatie vereisen, dat wil zeggen procedurele/bewuste sedatie.

• Eculizumab

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

• Inebilizumab

  • Adult patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.
• Inotersen
• Remimazolam
• Ronopterin

• Satralizumab

  • Patients with neuromyelitis optica (NMO) or neuromyelitis optica spectrum disorders (NMOSD). (Vanaf 12 jaar.)

Oncology other

• Dostarlimab

  • Monotherapy in women with advanced or recurrent MSI-H and MSS endometrial cancer who progressed on or after a platinum-based regimen.

• Entrectinib

  • Locally advanced or metastatic solid tumors with NTRK gene fusion in adult and pediatric patients
• Erlotinib ^G

• Ivosidenib

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

• Nivolumab

  • Extension of indication to include treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

• Pembrolizumab

  • Treatment of recurrent locally advanced or metastatic oesophageal cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have received prior systemic therapy.
  • 1L Colorectaalcarcinoom, MSI-High
• Pexidartinib
• Sodium thiosulfate

Other chronic immune diseases

• Anakinra

  • Kineret is indicated for the treatment of Familial Mediterranean Fever (FMF). Kineret should be given in combination with colchicine, if appropriate.

• Apremilast

  • Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy.

• Belimumab

  • Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody- positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti dsDNA and low complement) despite standard therapy.
  • Adult Patients With Active Lupus Nephritis

• Berotralstat

  • Treatment for the Prevention of Attacks in patients with Type I and II Hereditary Angioedema
• Elobixibat

• Emapalumab

  • Gamifant is indicated for the treatment of pediatric patients aged under 18 years with primary haemophagocytic lymphohistiocytosis (pHLH).
• Forigerimod

• Imlifidase

  • Prevention of graft rejection (desensitisation) following kidney transplantation.

• Lanadelumab

  • Takhzyro is geïndiceerd voor de routinematige preventie van terugkerende aanvallen van hereditair angio-oedeem (HAE) bij patiënten van 12 jaar en ouder.
• Lesinurad / allopurinol
• Naldemedine
• RP-L201
• Teprasiran
• Teprotumumab
• Triamcinolone
• Voclosporin

Other hematology

• Carmustine ^G
• Fostamatinib
• Lusutrombopag
• pegfilgrastim

Other medication for cardiovascular diseases

• Allogenic immunomodulatory progenitor cells
• Angiotensin II
• Apabetalon

• Dapagliflozine

  • Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

• Empagliflozine

  • Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
  • Chronic Heart Failure With Preserved Ejection Fraction (HFpEF).
• Icosapent ethyl
• PLX-PAD
• Regadenoson ^IND
• Tafamidis ^IND

• Ticagrelor

  • Reducing recurrent stroke and death in patients who have already suffered an acute ischaemic stroke or high-risk transient ischaemic attack (TIA) in the previous 24 hours.
  • Extension of indication to include, in co administration with acetylsalicylic acid (ASA), the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD)and type 2 diabetes mellitus (T2DM) without a history of myocardial infarction who have undergone percutaneous coronary intervention (PCI).

• Treprostinil

  • Treatment of adults with chronic thromboembolic pulmonary hypertension (CTEPH) who cannot have surgery, and in patients whose CTEPH continues or has come back after surgery.
• Udenafil

• Valsartan / sacubitril

  • Post acute Myocardial Infarction
  • Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with ejection fraction below 55/60%

• Vericiguat

  • Hartfalen met verminderde ejectiefractie (HFrEF)

Other metabolism and Endocrinology

• Dapagliflozine

  • Renal outcomes and cardiovascular mortality in patients with chronic kidney disease.

• Elamipretide

  • Barth syndrome

• 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 60 kg and obesity (BMI corresponding to ≥30 kg/m2 for adults).
• Lumasiran
• Nolasiban
• Romosozumab

• Setmelanotide

  • Rare genetic obesity disorders including pro-opiomelanocortin (POMC) deficiency, LepR deficiency, Bardet-Biedl syndrome, Prader-Willi syndrome and Alstrom syndrome.

Other non-oncological hematological medications

• Autologe CD34-positieve cellen die het gen voor βA-T87Q-globine coderen

  • 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
• Avatrombopag
• Crizanlizumab
• Daprodustat

• Deferasirox

  • Geïndiceerd voor de behandeling van: 1) chronische ijzerstapeling als gevolg van veelvuldige bloedtransfusies bij patiënten van 6 jaar en ouder met bètathalassemie major. 2) chronische ijzerstapeling als gevolg van bloedtransfusies wanneer deferoxamine behandeling gecontra-indiceerd of inadequaat is in de volgende patiëntengroepen: pediatrische patiënten met bètathalassemie major met ijzerstapeling als gevolg van veelvuldige bloedtransfusies in de leeftijd van 2 tot 5 jaar, volwassen en pediatrische patiënten met bètathalassemie major met ijzerstapeling als gevolg van occasionele bloedtransfusies (<7 ml/kg/maand rode bloedcellen) in de leeftijd van 2 jaar en ouder en volwassen en pediatrische patiënten met andere anemieën in de leeftijd van 2 jaar en ouder. 3) chronische ijzerstapeling waarbij chelatietherapie noodzakelijk is en wanneer deferoxaminebehandeling gecontra-indiceerd of inadequaat is bij patiënten in de leeftijd van 10 jaar en ouder met niet-transfusie-afhankelijke thalassemiesyndromen.
  • Geïndiceerd voor de behandeling van: 1) chronische ijzerstapeling als gevolg van veelvuldige bloedtransfusies bij patiënten van 6 jaar en ouder met bètathalassemie major. 2) chronische ijzerstapeling als gevolg van bloedtransfusies wanneer deferoxamine behandeling gecontra-indiceerd of inadequaat is in de volgende patiëntengroepen: pediatrische patiënten met bètathalassemie major met ijzerstapeling als gevolg van veelvuldige bloedtransfusies in de leeftijd van 2 tot 5 jaar, volwassen en pediatrische patiënten met bètathalassemie major met ijzerstapeling als gevolg van occasionele bloedtransfusies (<7 ml/kg/maand rode bloedcellen) in de leeftijd van 2 jaar en ouder en volwassen en pediatrische patiënten met andere anemieën in de leeftijd van 2 jaar en ouder. 3) chronische ijzerstapeling waarbij chelatietherapie noodzakelijk is en wanneer deferoxaminebehandeling gecontra-indiceerd of inadequaat is bij patiënten in de leeftijd van 10 jaar en ouder met niet-transfusie-afhankelijke thalassemiesyndromen.

• Eculizumab

  • Paroxysmal nocturnal haemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS)
  • Paroxysmal nocturnal haemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS)
  • Paroxysmal nocturnal haemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
• Ferumoxytol

• Hydroxycarbamide

  • Geïndiceerd voor de preventie van recidiverende, pijnlijke vaso-occlusieve crises waaronder het 'acute chest syndrome' bij volwassenen, adolescenten en kinderen ouder dan 2 jaar met symptomatische sikkelcelziekte.

• Luspatercept

  • Adult patients with Beta-thalassemia, who are transfusion dependent.

• Mepolizumab

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

• 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.
• Roxadustat
• Thrombomodulin alfa
• Vadadustat
• Voxelotor

Ovarian cancer

• Atezolizumab

  • 1L OC (ovarian, fallopian tube, and primary peritoneal cancer) in combination with carboplatin+paclitaxel+bevacizumab

• Niraparib

  • Extension of indication to include the maintenance treatment of adult patients with advanced high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy for Zejula in monotherapy.

• Olaparib

  • Maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
  • Extension of indication to include the use of Lynparza tablets in combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy with bevacizumab.

• Veliparib

  • Serous epithelial ovarian, fallopian tube or primary peritoneal cancer with BRCA1 mutation, stage III or IV high-grade - first-line with carboplatin and paclitaxel.

Pain

• Bupivacaine

  • Indicated for prolonged acute pain management and reduction in need for opioids in adults.
• Bupivacaine / meloxicam
• Neridronic Acid

• Tanezumab

  • Moderate to severe chronic pain associated with osteoarthitis.

Pancreatic cancer

• Eryaspase (Asparaginase)

  • Behandeling van pancreatic adenocarcinoma die gefaald hebben op eerstelijns therapie

• Olaparib

  • Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.

Parkinson's

• Amantadine
• Apomorphine
• Istradefylline
• Levodopa

• Levodopa / carbidopa

  • Parkinson
• Pimavanserin

Prostate cancer

• 177Lu-PSMA617

• 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 voorwie behandeling met chemotherapie nog niet klinisch geïndiceerd is ; - de behandeling van mCRPC bij volwassen mannenbij wie de ziekte progressief was tijdens of na een chemotherapieschema op basis van docetaxel.
• Abiraterone / apalutamide

• Apalutamide

  • Erleada is indicated in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).

• Cabazitaxel

  • Cabazitaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of adult patients with metastatic castration resistant prostate cancer previously treated with a docetaxel containing regimen.
• 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.

• Enzalutamide

  • Adult men with metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen depreviation therapy.

• Niraparib

  • mCRPC met DNA repair anomalies na 2-3 eerdere lijnen van behandeling waarvan 1 taxaan-bevattend regime en 1 androgeen-receptor (AR)-gerichte behandeling (abiraterone, enzalutamide of apalutamide).

• Olaparib

  • Extension of indication to include the use of Lynparza tablets as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene mutations (germline and/or somatic) who have progressed following a prior new hormonal agent.

• Relugolix

  • Advanced Prostate Cancer

Rheumatism

• Anifrolumab

  • Adult Patients With moderately to severely Active Systemic Lupus Erythematosus

• Filgotinib

  • Behandeling van matige tot ernstige reumatoïde artritis bij volwassen patiënten, die onvoldoende reageren op één of meer DMARD's of deze niet verdragen.

• Guselkumab

  • Psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.

• Ixekizumab

  • Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy and patients 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 to nonsteroidal anti-inflammatory drugs (NSAIDs).
• Olokizumab

• Secukinumab

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

• Tocilizumab

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

• Tofacitinib

  • Treatment of active polyarticular course juvenile idiopathic arthritis patients 2 years of age and older.

• Upadacitinib

  • Patients With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD).
  • Ankylosing Spondylitis
  • Rinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Rinvoq may be used as monotherapy or in combination with methotrexate.

• Ustekinumab

  • Matig tot ernstige systemische lupus erythematodes (SLE).

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

  • Treatment of spinal muscular atrophy (SMA) in pediatric and adult patients (wordt onderzocht voor type 1 en daarnaast voor type 2 en 3)

Schizophrenia, psychosis

• Lurasidone

  • Extension of indication for the treatment of schizophrenia in adolescent from 13 to less than 18 years.
• Olanzapine / samidorphan

Skin cancer

• Atezolizumab

  • mM 1L BRAF wild type in combinatie met cobimetinib
  • mM 1L BRAF+ in combinatie met cobimetinib en vemurafenib.

• Cemiplimab

  • Libtayo wordt onderzocht in patiënten met gevorderd basaalcelcarcinoom van de huid (cBCC) die progressie vertonen onder behandeling met hedgehog inhibitor therapie of intolerant waren voor eerdere behandeling met hedgehog inhibitor therapie.
  • Monotherapy treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.

• Dabrafenib / Trametinib

  • Dabrafenib in combinatie met trametinib is geïndiceerd voor de adjuvante behandeling van volwassen patiënten met melanoom in stadium III met een BRAF V600-mutatie, na complete resectie.

• Lifileucel

  • Maliganant melanoma, advanced melanoma
• Seviprotimut-L
• Spartalizumab
• Tavokinogene telseplasmid

Skin diseases

• Abrocitinib

  • Moderate-to-severe atopic dermatitis in adult and adolescent patients (from 12 years of age).

• Baricitinib

  • Extension of Indication to include a new indication in the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy.

• Bimekizumab

  • Psoriasis
• Clascoterone
• Crisaborole
• Difelikefalin
• Glycopyrronium tosylate

• Ixekizumab

  • Taltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for systemic therapy.

• Lebrikizumab

  • Moderate to Severe Atopic Dermatitis in patients aged 12 years and older
• Ligelizumab
• Nemolizumab

• Omalizumab

  • Chronische Induceerbare Urticaria (CINDU)

• Risankizumab

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

• Secukinumab

  • Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.

• Tapinarof

  • Adult Plaque Psoriasis
  • Atopische dermatitis

• Tildrakizumab

  • Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
• Tirbanibulin

• Tralokinumab

  • treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.
• Trifarotene

• Upadacitinib

  • Upadacitinib is indicated for the treatment of moderate to severe atopic dermatitis in patients who have failed to respond to conventional (topical) therapies.

• Ustekinumab

  • Stelera is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Sleep disorders

• JZP-258
• Lemborexant
• Melatonin

• Natriumoxybaat

  • Narcolepsy with cataplexy in children (ages 7-17)
• Solriamfetol

• Tasimelteon

  • Jet lag disorder

Stem cell transplants

• Axicabtagene ciloleucel

  • Yescarta is geïndiceerd voor de behandeling van volwassen patiënten met recidiverend of refractair diffuus grootcellig B-cellymfoom (DLBCL) en primair mediastinaal grootcellig B-cellymfoom (PMBCL), na twee of meer lijnen systemische therapie.
  • Recidiverend of refractair na 1 of meer lijnen van therapie DLBCL.
• BL-8040

• Ibrutinib

  • Chronische graft-versus-host disease
• Inolimomab
• Itacitinib
• KTE-X19
• LCAR-B38M CAR-T cell therapy
• Narsoplimab

• Remestemcel-L

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

• Ruxolitinib

  • Acute en chronische steroïd-refractaire ‘Graft-versus-host-ziekte’ na hematopoietische stamceltransplantatie.
• Tabelecleucel

• Tisagenlecleucel-T

  • Behandeling van volwassen patiënten met een recidief of refractair diffuus grootcellig B-cellymfoom (DLBCL) na twee of meer lijnen systemische therapie.

• Treosulfan

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

Stomach cancer

• Avapritinib

  • Treatment of patients with unresectable or metastatic gastrointestinal stromal tumors (GIST)

• Masitinib

  • Gastro Intestinale Stroma Tumor (GIST)
• Ripretinib
• Rivoceranib

Thyroid cancer

• Selpercatinib

  • Patients With RET-Mutant Medullary Thyroid Cancer

Unknown

• Vibegron

Viral infections other

• Baloxavir marboxil

  • Treatment of influenza in patients aged 12 and above, including patients at high risk of developing influenza-related complications and for post-exposure prophylaxis of influenza in individuals aged 12.

• 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.
• Cabotegravir

• Darunavir / cobicistat

  • Rezolsta is indicated, in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus‑1 (HIV‑1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg).
• Etravirine
• Fostemsavir
• Ibalizumab
• Maribavir

• Remdesivir

  • The treatment of hospitalised patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation)
• Zanamivir