Published on 8 December 2020

ADHD

• Lisdexamfetamine

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

ALL

• Blinatumomab

  • Extension of indication to include the use of blinatumomab 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 consolidation therapy
  • Blincyto is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.

• 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

  • Behandeling van volwassen patiënten recidiverend of refractair na 2 of meer lijnen van therapie met refractaire B-cel acute lymfoblastaire leukemie (ALL).

ALS

• Arimoclomol

  • Amyotropic Lateral Sclerosis

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.

• 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
• Guadecitabine
• 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

  • Extension of indication for Venclyxto (venetoclax) in combination with Hypomethylating Agents (HMAs) or Low Dose Cytarabine (LDAC) for the treatment of adult patients with newly-diagnosed acute myeloid leukaemia (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

  • Recidiverend of refractair diffuus grootcellig B-cellymfoom (DLBCL), primair mediastinaal grootcellig B-cellymfoom (PMBCL) en follicularlymfoom, na tenminste twee eerdere behandelingen.

• 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

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

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

• 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.
• Dabigatran ^G
• Dabigatran etexilate ^IND

• Ravulizumab

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

• Rivaroxaban

  • Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Asthma

• Beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium

  • Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.
• Budesonide / formoterol ^IND

• 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
• 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.
  • Indicatie uitbreiding 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

  • Treatment of patients with bacteraemia that occurs in association with, or is 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.
  • Zavicefta is indicated in adults and children aged 3 months and older and adolescents for the treatment of the following infections in adults with Complicated intra-abdominal infection (cIAI), Complicated urinary tract infection (cUTI), including pyelonephritis, Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).
• 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.

• 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 30 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
• Iclaprim

• 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.
• 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

  • Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and adolescents 12 years of age and older.
  • 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 as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC), after prior platinum containing chemotherapy, or who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5%.

• Avelumab

  • Bavencio is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed with platinum-based induction chemotherapy.

• 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 (3L).
• Oportuzumab monatox

• Pembrolizumab

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

• Ramucirumab

  • Advanced urothelial cancer, second line.

• Tremelimumab

  • First line bladder cancer in combinatie met durvalumab

Bowel diseases

• Adalimumab

  • Humira is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

• Alicaforsen

  • Ulcerative colitis
  • Pouchitis

• Filgotinib

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

• Remestemcel-L

  • Ziekte van Crohn

• Tenapanor

  • Irritable bowel syndrome with constipation

• Upadacitinib

  • Moderately to Severely Active Ulcerative Colitis

Brain cancer

• Asunercept
• Autologous glioma tumor cell lysates
• Brain cancer vaccine
• 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 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 (OlympiA).

• Paclitaxel

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

• Palbociclib

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

• Pembrolizumab

  • Breast cancer, metastatic, triple negative, 1L.
  • Tripple Negative Breast Cancer - Neoadjuvant and adjuvant.
• Pertuzumab / trastuzumab

• Sacituzumab govitecan

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

• Trastuzumab deruxtecan

  • Patients with HER2 low, unresectable, and/or metastatic breast cancer previously treated with 1-2 prior lines of chemotherapy
  • 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.
  • 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

  • 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.

• Veliparib

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

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.

• Venetoclax

  • Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

• ibrutinib

  • In combinatie met venetoclax voor eerstelijns CLL.

COPD

• Formoterol / glycopyronium / budesonide

  • Trixeo Aerosphere is indicated as a 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 combination of a long-acting beta2‑agonist and a long‑acting muscarinic antagonist
• Revefenacin

Cardiovascular diseases

• Avacopan
• 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.
• Tegafur / gimeracil / oteraci ^IND

Cystic fibrosis

• Bamocaftor / tezacaftor / ivacaftor

• Elexacaftor / tezacaftor / ivacaftor

  • Extension of indication to extend the indication of Kalydeco (ivacaftor) tablets in combination regimen with Kaftrio (ivacaftor/tezacaftor/elexacaftor) tablets for the treatment of adults and adolescents aged 12 years and older with cystic fibrosis (CF) who have at least one F508del mutation in the CFTR gene
  • An Extension of indication for Sarclisa to add combination with carfilzomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

• 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 4 months, toddlers and children weighing 5 kg to less than 25 kg 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
  • Extension of indication to extend the indication of Kalydeco (ivacaftor) tablets in combination regimen with Kaftrio (ivacaftor/tezacaftor/elexacaftor) tablets for the treatment of adults and adolescents aged 12 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 150 mg 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.
  • 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

  • Patients With Type 2 Diabetes Mellitus Aged 10 to Below 18 Years Old
  • 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 lispro (ultra rapid formulation)
• 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.
• Teplizumab

• Tirzepatide

  • In Combination With Monotherapy of Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus

Duchenne

• Edasalonexent

• Idebenone

  • Treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) NOT using glucocorticoids. Respiratory dysfunction is defined when PEF%p or FVC%p fall below 80% of the predicted value
  • Treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) using glucocorticoids. Respiratory dysfunction is defined when PEF%p or FVC%p fall below 80% of the predicted value

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.
  • Extension of indication for use as adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC) for patients 1 year 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.
• Perampanel ^IND

Eye disorders

• Abicipar

• Aflibercept

  • Diabetic macular edema
• Aganirsen

• Brolucizumab

  • Diabetic Macular Edema (DME)

• Faricimab

  • Wet age-related macular degeneration (AMD) & Diabetic Macular Edema (DME)
• Latanoprostene bunod
• Lenadogene nolparvovec
• Lifitegrast
• Netarsudil / latanoprost
• 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).
  • Treatment of neovascular age-related macular degeneration (AMD)

• Reproxalap

  • Allergic conjunctivitis
• Sepofarsen
• Timrepigene emparvovec
• Tivanisiran
• Voretigene neparvovec

Head and neck cancer

• Afatinib ^IND
• Brilacidin

• Durvalumab

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

• 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.

Headache

• Eptinezumab

  • Migraine profylaxe
• 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

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.
• Eptacog beta (activated)
• Etranacogene dezaparvovec
• Fibrinogen
• Fidanacogene elaparvovec
• Valoctocogene roxaparvovec

Hodgkin's lymphoma

• Pembrolizumab

  • Extension of the currently approved therapeutic indication for the treatment of relapsed or refractory classical Hodgkin lymphoma (rrcHL) in adults to an earlier line of therapy and to include paediatric patients (2L).

Hormonal disorders

• Levoketoconazole

• Linzagolix

  • Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids
• Lonapegsomatropin
• Macimorelin

• Octreotide

  • Acromegalie
• Osilodrostat

• Relugolix

  • Patients With Endometriosis-Associated Pain
  • Treatment of uterine fibroids.

• Somapacitan

  • Growth hormone deficiency in adults and pre-pubertal children

• Somatrogon

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

• Tenapanor

  • Hyperphosphatemia

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.
• Umbralisib

Infectious diseases other

• Anidulafungin ^IND

• Ibrexafungerp

  • Patients with acute Vulvovaginal Candidiasis

• Posaconazol

  • 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.
  • Extension of indication to include treatment of invasive aspergillosis in adults
• 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).

• Cabozantinib

  • Cabozantinib combined with nivolumab in patients with previously untreated advanced or metastatic renal cell carcinoma.

• Ipilimumab

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

• Pembrolizumab

  • Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy.
  • Advanced Renal Cell Carcinoma (1L) in combination with lenvatinib.
• Tivozanib ^IND

Leukemia

• Asciminib

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

Lipid-lowering medications

• 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

  • Treatment of homozygous familial hypercholesterolemia (HoFH)

• 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.

• 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 triglyceriden verlagende 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.

• Pembrolizumab

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

• Pemigatinib

  • Treatment of locally advanced or metastatic cholangiocarcinoma relapsed or refractory after at least one line of systemic therapy. Alleen de patiënten met een FGFR2 mutatie komen in aanmerking.

Liver diseases

• Givosiran

• Maralixibat

  • Pediatric patients with Progressive Familial Intrahepatic Cholestasis (PFIC).

• Obeticholic acid

  • Fibrosis due to Non-Alcoholic Steatohepatitis (NASH)

• Odevixibat

  • Treatment of Progressive Familial Intrahepatic Cholestasis
• Seladelpar

Lung cancer

• Amivantimab

• 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.
  • Geïndiceerd voor gebruik als monotherapie voor de behandeling van volwassen patiënten met ALK‑positief (anaplastisch lymfoom kinase) gevorderd niet‑kleincellig longcarcinoom (NSCLC) die eerder zijn behandeld met alectinib.

• Canakinumab

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

• Cemiplimab

  • Eerstelijns behandeling voor volwassen patiënten met lokaal gevorderd of gemetastaseerde plaveiselcel en niet-plaveiselcel NSCLC (stadium IIIB/C-IV) met een PD-L1 over expressie ≥50%.
• Dacomitinib

• 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).

• 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.

• Lurbinectedin

  • Small cell lung cancer (SCLC)
• Mobocertinib

• Nivolumab

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

• Osimertinib

  • Extension of indication of Tagrisso to include the adjuvant treatment after complete tumour resection in EGFR mutant non-small cell lung cancer (NSCLC) patients.

• 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).

• Pralsetinib

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

• Selpercatinib

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

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.

• 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).
• Molgramostim

• Nintedanib

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

• Omalizumab

  • Xolair is indicated as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe CRSwNP for whom therapy with INC does not provide adequate disease control.
• Sarizotan

Mesothelioma

• Nivolumab

  • Mesothelioom (in combinatie met ipilimumab).

Metabolic diseases

• Arimoclomol citraat
• 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

• Burosumab

  • Crysvita is indicated for the treatment of X-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults.
• Chenodeoxycholzuur
• Elivaldogene autotemcel
• Hydrocortisone
• Kaliumcitraat / kaliumwaterstofcarbonaat

• Lonafarnib

  • Hutchinson-Gilford Progeria Syndrome and Progeroid Laminopathies.
• 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

  • 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.

• 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.

• 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 i.c.m. VRd voor patiënten die niet in aanmerking komen voor een ASCT.
  • Smouldering multipel myeloom.
  • Subcutaneous formulation indicates for Relapsed or Refractory Multiple Myeloma.
  • Amyloidose eerstelijnsbehandeling in combinatie met bortezomib, cyclofosfamide en dexamethason.
  • Multipel myeloom frontline behandeling in combinatie met VRd voor patiënten die in aanmerking komen voor een ASCT.
  • 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

  • Treatment of adult patients with relapsed/refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

• 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.
• JNJ-4528

• 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.

• 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.

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.

• Masitinib

  • Multiple sclerosis, primary-progressive or relapse-free secondary progressive

• Natalizumab

  • "Tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: •Patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods) •Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
• Ofatumumab

• 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

• Sugammadex

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

Muscular diseases other

• Mexiletine HCl

Myeloproliferative disorders

• Fedratinib

  • Myelofibrose, JAK inhibitor naïve patients and post ruxolitinib.
• Ropeginterferon alfa-2b

Neuroendocrine cancer

• Selumetinib

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

Neurological disorders other

• 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.

• Eculizumab

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

• Inebilizumab

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

• Satralizumab

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

Oncology other

• 131I-omburtamab

• Dostarlimab

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

• 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.
• Glucarpidase

• Ivosidenib

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

• Nivolumab

  • 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

  • Women With Persistent, Recurrent, or Metastatic Cervical Cancer (1L).
  • Advanced Endometrial Cancer (2L+) in combination with lenvatinib.
  • Locally advanced or metastatic esophageal carcinoma (1L)
  • Extension of indication to include first-line treatment of unresectable or metastatic microsatellite instability-high (MSI H) or mismatch repair deficient (dMMR) colorectal cancer in adults for Keytruda.
• 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.
• Belatacept ^IND

• Belimumab

  • Extension of indication to include treatment of lupus nephritis for belimumab

• 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

• 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.

• Lanadelumab

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

Other hematology

• Carmustine ^G

Other medication for cardiovascular diseases

• Allogenic immunomodulatory progenitor cells
• Angiotensin II
• Apabetalon

• Dapagliflozine

  • Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.
  • Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
• Emiplacel

• Empagliflozine

  • Extension of indication to include treatment of adult patients with heart failure and reduced ejection fraction for Jardiance
  • Chronic Heart Failure With Preserved Ejection Fraction (HFpEF).
• Icosapent ethyl
• Regadenoson ^IND
• Tafamidis ^IND

• Ticagrelor

  • Extension of indication to include, in co-administration with acetylsalicylic acid (ASA), the prevention of stroke in adult patients with acute ischaemic stroke or 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

• Vericiguat

  • Hartfalen met verminderde ejectiefractie (HFrEF)

Other metabolism and Endocrinology

• Autologous human chondrocytes in vitro expanded

• Dapagliflozine

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

• Elamipretide

  • Barth syndrome
• Fexapotide

• 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

• Semaglutide

  • Obesitas bij volwassenen

• Setmelanotide

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

• Vosoritide

  • Treatment of achondroplasia for children 2 years and older, whose epiphyses are not closed.

Other non-oncological hematological medications

• 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

• 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.
  • 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

  • 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.

• 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.

• Romiplostim

  • Extension of indication to add the use of romiplostim in adult patients who have had idiopathic thrombocytopenic purpura (ITP) for ≤ 12 months and who have had an insufficient response to corticosteroids or immunoglobulins.
• Roxadustat
• Thrombomodulin alfa
• Vadadustat
• Voxelotor

Ovarian cancer

• Atezolizumab

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

• 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.

• Olaparib

  • Lynparza in combination with bevacizumab is indicated 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 in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability.

• 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

  • Exparel is indicated as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults
• Bupivacaine / meloxicam
• Lidocaïne
• Neridronic Acid

• Tanezumab

  • Chronic Low Back Pain for ≥3 months
  • 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

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 / carbidopa

  • Parkinson
• Pimavanserin

Prostate cancer

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

• Enzalutamide

  • Adult men with metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy.
  • De behandeling van volwassen mannen met niet-gemetastaseerd hoog risico-CRPC (castratieresistent prostaatcarcinoom).

• 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 patients with metastatic castration-resistant prostate cancer (mCRPC) with breast cancer susceptibility gene 1/2 (BRCA1/2) mutations, a subpopulation of homologous recombination repair (HRR) gene mutations.

• Relugolix

  • Advanced Prostate Cancer.

Rheumatism

• Anifrolumab

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

• Filgotinib

  • Jyseleca 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). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX).

• Guselkumab

  • Addition of a new indication for the treatment of active 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

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

• Upadacitinib

  • RINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who haveresponded inadequately to, or who are intolerant to one or more DMARD. RINVOQ may be used as monotherapy or in combination with nonbiologic DMARDs.​
  • Extension of indication to include the treatment of active ankylosing spondylitis in adult patient for Rinvoq

• 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

  • Latuda is indicated for the treatment of schizophrenia in adults and adolescent aged 13 years and over.
• Olanzapine / samidorphan

Skin cancer

• Atezolizumab

  • 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.
• Darleukin fibromun

• Lifileucel

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

Skin diseases

• 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.

• Baricitinib

  • Olumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy.
• Beremagene geperpavec
• Berkenschorsextract ^IND

• Bimekizumab

  • Treatment of plaque psoriasis
• Clascoterone
• Crisaborole
• Difelikefalin

• Dupilumab

  • Severe atopic dermatitis in children 6 to 11 years old who are candidates for systemic therapy.
• 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
• Nemolizumab

• 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
• 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.

Sleep disorders

• JZP-258
• Lemborexant

• Natriumoxybaat

  • Treatment of narcolepsy with cataplexy in adult patients, adolescents and children from the age of 7 years.
• Solriamfetol

• Tasimelteon

  • Jet lag disorder

Stem cell transplants

• Axicabtagene ciloleucel

  • Recidiverend of refractair na 1 of meer lijnen van therapie DLBCL.
• BL-8040

• Ibrutinib

  • Chronische graft-versus-host disease.
• Inolimomab
• Itacitinib
• Narsoplimab
• Omidubicel

• 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
• Thiotepa ^G

• 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.

Stomach cancer

• 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.

• Masitinib

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

• Trastuzumab deruxtecan

  • Treatment of ER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens

Thyroid cancer

• 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).

Unknown

• Vibegron

Viral infections other

• APN01
• Atazanavir / cobicistat

• 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.

• 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

• Dapagliflozine

  • Treatment of hospitalized adult patients with COVID-19 to prevent organ damage and to improve survival
• Dexamethasone ^IND
• Etravirine ^IND
• Fostemsavir

• Glecaprevir / pibrentasvir

  • Extension of indication variation to include the treatment of children from 3 to 12 years of age for the approved Maviret indication

• Human normal immunoglobulin

  • Replacement therapy in adults, children and adolescents (0‑18 years) in: Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF) or serum IgG level of <4 g/l.
• Ibalizumab
• Maribavir

• Remdesivir

  • Veklury is geïndiceerd voor de behandeling van coronavirus disease 2019 (COVID-19) bij volwassenen en jongeren (vanaf 12 jaar die minstens 40 kg wegen) met pneumonie die aanvullende zuurstof nodig hebben.
• Tecovirimat
• Zanamivir