Chronische immuunziekten

Chronische immuunziekten, overig

• 13-grass pollen extract
• Allergeenextract huisstofmijt ^IND
• Arachis hypogaea (pinda) allergenen ^IND
• Atrasentan

• Baricitinib

  • Extension of indication to include treatment of adolescent patients (12 to less than 18 years) with severe alopecia areata.

• 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 (see section 5.1).

• Berotralstat

  • Berotralstat monotherapy for prophylactic treatment of hereditary angioedema in children aged 2 to 12.
• Briquilimab

• Budesonide

  • Kinpeygo is indicated for the treatment of adults with a urine protein excretion-to-creatinine ratio (UPCR) ≥1,0g/dayg (or urine protein-to-creatinine ratio ≥0,8g/g).
• Deucrictibant
• Donidalorsen

• Dupilumab

  • Dupixent is geïndiceerd voor de behandeling van eosinofiele oesofagitis in volwassenen, adolescenten en kinderen van een jaar en ouder. Die ongecontroleerd zijn op, intolerant zijn voor, of die geen kandidaat zijn voor conventionele therapie.
• Garadacimab
• Ianalumab

• Imlifidase

  • Imlifidase in combination with standard of care for treatment of severe anti-glomerular basement membrane disease in adults and elderly.

• Iptacopan

  • Fabhalta is indicated for the treatment of adult patients with complement 3 glomerulopathy (C3G) in combination with a renin-angiotensin system (RAS) inhibitor, or in patients who are RAS-inhibitor intolerant, or for whom a RAS inhibitor is contraindicated.

• Leniolisib

  • Behandeling van Geactiveerd PI3 Kinase Delta-Syndroom (APDS) bij volwassenen en adolescenten van twaalf jaar en ouder.
  • Leniolisib monotherapy for treatment of Activated PI3 kinase delta syndrome in infants, toddlers and children between 1 to 12 years of age.
• Lonvoguran ziclumeran

• Masitinib

  • Masitinib in combination with best supportive care for third line or later treatment of severe Indolent systemic mastocytosis and of for the treatment of severe smouldering Systemic mastocytosis i in adults and elderly who are unresponsive to optimal symptomatic treatment.
• Mavorixafor
• Mycofenolaatmofetil ^IND

• Obinutuzumab

  • Gazyvaro in combination with mycophenolate mofetil (MMF), is indicated for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis (LN)

• Pegcetacoplan

  • Extension of indication to include treatment of adults and adolescents aged 12 to 17 years with C3 glomerulopathy or primary immune complex membranoproliferative glomerulopathy.

• Sarilumab

  • Kevzara is indicated for the treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who experience a relapse during corticosteroid taper.
• Sebetralstat
• Secukinumab-bthr ^BS
• Sibeprenlimab
• Tadekinig alfa

• Tezepelumab

  • Tezepelumab monotherapy for treatment of Eosinophilic oesophagitis in adolescents, adults and elderly with previously documented standard of care treatment.

• Upadacitinib

  • Moderate to severe Hidradenitis suppurativa in adolescents, adults and elderly who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy.
  • Severe Alopecia areata in adolescents and adults.

Darmziekten

• Apraglutide

• Etrasimod

  • Velsipity is geïndiceerd voor de behandeling van patiënten van 16 jaar en ouder met matig tot ernstig actieve colitis ulcerosa (CU) die onvoldoende reageren of niet meer reageren op of intolerant zijn voor conventionele behandeling of een biologisch middel.
• Glepaglutide

• Guselkumab

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

• Hydrocortison

  • Hydrocortisone monotherapy for treatment of active rectum Ulcerative colitis in adults and elderly.
• Ivarmacitinib

• Mirikizumab

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

• Risankizumab

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

• Teduglutide

  • Treatment of Short Bowel Syndrome.

• Ustekinumab

  • Extension of indication to include treatment of moderately to severely active Crohnʼs disease in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.

Hart- en vaatziekten

• Secukinumab

  • Secukinumab in combination with glucocorticoid taper regimen for treatment of giant cell arteritis in adults over 50 and elderly.

Huidziekten

• Afamelanotide

  • Afamelanotide in combination with Narrow-Band Ultraviolet B (NB-UVB) light for treatment of stable or active generalized Vitiligo in adolescents, adults and elderly.
• Beremagene geperpavec
• Clascoterone
• Deuruxolitinib
• Dipalmitoyl Hydroxyproline

• Dupilumab

  • Dupixent is geindiceerd voor de behandeling van volwassenen met matig-ernstig bulleus pemfigoid (BP).
  • Extension of indication to include treatment of moderate to severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years whose disease is inadequately controlled by H1 antihistamines and who are naive to anti-IgE therapy for CSU.
  • Extension of indication to include treatment of moderate to severe chronic spontaneous urticaria in adults and adolescents 12 years and older, whose disease is inadequately controlled by H1 antihistamines and who are naive to anti-IgE therapy for CSU.

• Guselkumab

  • Tremfya 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
• Humane allogene, uit de huid afkomstige ABCB5+ mesenchymale stromale cellen
• Icotrokinra
• Imsidolimab

• Lebrikizumab

  • Lebrikizumab in combination with topical corticosteroid for treatment of moderate to severe atopic dermatitis in infants, toddlers over 6 months, children and adolescents.

• Minocycline

  • Minocycline monotherapy for treatment of moderate to severe inflammatory lesions of Papulopustular rosacea in adults and elderly.
• Nemolizumab
• Povorcitinib ^IND
• Prademagene zamikeracel
• Remibrutinib

• Risankizumab

  • Extension application to include treatment of paediatric plaque psoriasis (6 to 18 years)

• Ritlecitinib

  • Treatment of patients with non-segmental vitiligo

• Roflumilast topicaal

  • Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age.

• Ruxolitinib (als fosfaat)

  • Volwassenen met matige atopische dermatitis die eerder zijn behandeld met topische corticosteroïden of topische calcineurine remmers of waarbij deze middelen zijn gecontra-indiceerd.
• Tirbanibuline ^IND

• Upadacitinib

  • Non-segmental Vitiligo in adolescents, adults and elderly who are eligible for systemic therapy.
• Zasocitinib

Oogaandoeningen

• Veligrotug

Reuma

• Anifrolumab

  • Subcutaneous Anifrolumab in Adult Patients with Systemic Lupus Erythematosus (SubQ Tulip).
• Dapansutrile

• Deucravacitinib

  • Sotyktu, alone or in combination with conventional synthetic disease modifying antirheumatic drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior DMARD therapy.

• Emapalumab

  • Emapalumab monotherapy for treatment of glucocorticoid-refractory Macrophage activation syndrome in infants, toddlers over 6 months of age, children, adolescents, adults and elderly with Stillʼs Disease.

• Filgotinib

  • Axial spondyloarthritis
• Golimumab ^BS

• Inebilizumab

  • Uplizna is indicated for the treatment of adult patients with active IgG4-RD (see section 5.1).

• Ixekizumab

  • Juvenile idiopathic arthritis (JIA). Juvenile psoriatic arthritis (JPsA): Taltz, alone or in combination with methotrexate, is indicated for the treatment of active JPsA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy. Enthesitis-related arthritis (ERA): Taltz, alone or in combination with methotrexate, is indicated for the treatment of active ERA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy.
• Lingolinurad
• Litifilimab

• Secukinumab

  • Extension of indication to include polymyalgia rheumatica in adults whose disease has responded inadequately to, or cannot tolerate conventional therapy.

• Tildrakizumab

  • Tildrakizumab monotherapy for treatment of active psoriatic arthritis in adults and elderly who have prior or no prior exposure to an anti-tumor necrosis factor agent.

• Upadacitinib

  • Extension of indication to include the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older
  • Rinvoq is indicated for the treatment of giant cell arteritis in adult patients.

Onbekend

• Atacicept