Lung diseases

Asthma

• Beclometason/formoterol/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.

• Benralizumab

  • Fasenra is geïndiceerd als aanvullende onderhoudsbehandeling bij volwassen patiënten met ernstig eosinofiel astma die onvoldoende onder controle is ondanks hoog gedoseerde inhalatiecorticosteroïden en langwerkende β-agonisten.
• Budesonide / formoterol ^IND
• Depemokimab

• Dupilumab

  • Dupixent is geïndiceerd bij kinderen van 6 tot 11 jaar als add-on onderhoudsbehandeling voor ernstige astma met type 2-ontsteking gekenmerkt door verhoogde eosinofiele in het bloed en/of verhoogde fractie uitgeademde stikstofmonoxide (FeNO), die onvoldoende onder controle zijn met inhalatiecorticosteroïden (ICS) in een gemiddelde tot hoge dosis plus een ander geneesmiddel voor onderhoudsbehandeling.
  • Dupixent is geïndiceerd bij volwassenen en adolescenten van 12 jaar en ouder als aanvullende onderhoudsbehandeling van ernstig astma met type 2 inflammatie gekenmerkt door verhoogde bloedeosinofielen en/of verhoogde FeNO, die onvoldoende kunnen worden behandeld met hooggedoseerde ICS plus een ander geneesmiddel voor onderhoudsbehandeling.
• Fevipiprant

• Fluticasone furoate / umeclidinium / vilanterol

  • Asthma in adults inadequately controlled with dual steroid/beta agonist therapy

• Formoterol / glycopyronium / budesonide

  • Maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium or high dose inhaled corticosteroid and a long-acting beta2-agonist.
• 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.
  • 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. Ook voor de behandeling van chronische idiopathische urticaria.

• Tezepelumab

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

• Tralokinumab

  • Severe asthma in adults and adolescents inadequately controlled on ICS + LABA.

COPD

• Beclometason/formoterol/glycopyrronium

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

• Beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium

  • Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting B2 agonist or a combination of a long-acting B2 agonst and a long-acting muscarinic antagonist.

• Benralizumab

  • Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) with exacerbation history.

• Dupilumab

  • Add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils for patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.
• Ensifentrine
• Fluticasone furoate / umeclidinium (bromide) / vilanterol (trifenatate)

• Fluticasone furoate / umeclidinium / vilanterol

  • Trelegy Ellipta is geïndiceerd als onderhoudsbehandeling bij volwassen patiënten met matige tot ernstige chronische obstructieve longziekte (COPD) die niet voldoende kunnen worden behandeld met een combinatie van een inhalatiecorticosteroïde en een langwerkende bèta2-agonist of een combinatie van een langwerkende bèta2-agonist en een langwerkende muscarine-antagonist (voor effecten op de symptoomcontrole en preventie van exacerbaties

• 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.
• Formoterol/glycopyronium
• Itepekimab

• Mepolizumab

  • Extension of indication to include treatment of Chronic Obstructive Pulmonary Disease (COPD).
• Revefenacin
• Tozorakimab ^IND

Cystic fibrosis

• Bamocaftor / tezacaftor / ivacaftor

• Elexacaftor / tezacaftor / ivacaftor

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

• Ivacaftor

  • Kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5kg to less than 25kg 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 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 tablets are indicated in a combination regimen with tezacaftor 100 mg/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 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.
  • Kalydeco granules are indicated for the treatment of children with cystic fibrosis (CF) aged 12-24 months and weighing 7 kg to less than 25 kg who have 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)
  • 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.
  • Kalydeco tablets are indicated in a combination regimen with ivacaftor /tezacaftor /elexacaftor tablets for the treatment of adults, and adolescents and children aged 6 years and older with cystic fibrosis (CF) who have at least one F508del mutation in the CFTR gene
• Ivacaftor / Tezacaftor / Elexacaftor ^IND

• Lumacaftor / ivacaftor

  • Cystische fibrose voor kinderen van 12 tot 24 maanden oud die homozygoot zijn voor de F508del CFTR genmutatie.
  • Extension of indication to include treatment of cystic fibrosis for children aged 1 to less than 2 years old of age who are homozygous for the F508del mutation in the CFTR gene.
  • Cystische fibrose voor kinderen van 2 tot 5 jaar oud die homozygoot zijn voor de F508del CFTR genmutatie

• Tezacaftor / ivacaftor

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

Lung diseases other

• Alpha-1 antitrypsin

• Ambrisentan

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

• Benralizumab

  • Patiënten met ernstige bilaterale neuspoliepen die nog steeds symptomatisch zijn ondanks de standaardbehandeling, dat wil zeggen het huidige gebruik van intra-nasale corticosteroïden (INCS) en eerdere chirurgie en/of het gebruik van systemische corticosteroïden.
  • Extension of indication to include treatment of eosinophilic granulomatosis.
• Brensocatib

• Ciclosporine

  • Ciclosporin in combination with standard therapy for the treatment of bronchiolitis obliterans syndrome in adults and the elderly after lung transplantation.
• Efzofitimod ^G
• Exoflo Extracellular Vesicles
• 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).
• Nerandomilast

• Nintedanib

  • Nintedanib Accord is a medicine used to treat adults with idiopathic pulmonary fibrosis (IPF), a disease of unknown cause in which fibrous tissue forms in the lungs; systemic sclerosis associated interstitial lung disease, a disease in which the immune system (the body’s natural defences) is overactive, causing production of fibrous tissue and progressive scarring of the lungs; other chronic fibrosing interstitial lung diseases which are progressive.
  • Ofev is indicated in children and adolescents aged 6 to 17 years for the treatment of clinically significant, progressive fibrosing interstitial lung diseases (ILDs).
• Pamrevlumab

• Pirfenidone

  • Extension of indication to include the treatment of unclassifiable interstitial lung disease (UILD) for Esbrie.
  • Extension of indication to include treatment of ‘advanced’ idiopathic pulmonary fibrosis (IPF) by the deletion of the current qualifier ‘mild to moderate’, in IPF patients with advanced lung function impairment (DLco < 40% of predicted) and at high risk of grade 3 pulmonary hypertension.

• Riociguat

  • Adempas is indicated for the treatment of PAH in paediatric patients aged less than 18 years of age and body weight ≥ 50 kg with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists.
  • Adempas is indicated for the treatment of PAH in paediatric patients aged 6 to less than 18 years with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists (see section 5.1).

• Sotatercept

  • Extension of indication to include in combination with other pulmonary arterial hypertension (PAH) therapies treatment of adult patients with PAH World Health Organisation Functional Class IV.
  • Treatment of pulmonary arterial hypertension.
• Tadalafil ^IND

• Tezepelumab

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

• Tocilizumab

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

• Treprostinil

  • Treprostinil monotherapy for treatment of idiopathic pulmonary fibrosis in adults over 40 years of age and elderly.
• Zinpentraxin alfa

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.
• Ciprofloxacin

• 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.

• 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.

• Pirfenidone

  • Asbestosis

• Rituximab

  • Refractaire (auto)immunologische longfibrose
• Sarizotan
• Selexipag

• Sirolimus

  • Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function

Unknown

• ARINA-1
• Colistimethaatnatrium ^IND
• Molgramostim ^IND

• Pirfenidone

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

Unknown

• Tanimilast