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Published on
8 December 2020
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Mechanism of action
Any mechanism of action
Unknown
Alkylating agent
Allergen
Allogeneic modified cell therapy
Amino acid
Anesthetic
Angiogenesis inhibitor
Antiandrogen
Antibiotic
Antibody-drug conjugate
Anticoagulant
Antifungals
Antihistamine
Antioxidant
Antisense oligonucleotide
Autologous modified cell therapy
Bcl-2 inhibitor
BET inhibitor
Calcineurin inhibitor
Cancer vaccine
Cannabinoid
CAR-T therapy
CDK4 / 6 tyrosine kinase inhibitor
CFS1R inhibitor
CGRP-directed antibody
Chelating agent
Coagulant
Combination therapy
Complement inhibitor
Corticosteroid
CTLA-4 antibody
Cytostatic
Disinfectant
Enzyme
Enzyme inhibitor
Enzyme replacement therapy
Gene therapy
GLP-1 receptor agonist
Glucagon analogue
Growth factor
HIV inhibitor
Hormonal therapy
Immunostimulation
Immunosuppression
Insulin preparation
Interferon inhibitor
Interleukin inhibitor
Ion channel blocker
JAK tyrosine kinase inhibitor
LABA / ICS
LABA / LAMA
LABA / LAMA / ICS
LAMA
MEK kinase inhibitor
Neurotoxin
Neurotransmitter
Oncolytic adenovirus
Other
Other, see general comments
PARP inhibitor
PD-1 / PD-L1 inhibitor
Proteasome inhibitor
Protein chaperone
Receptor agonist
Receptor antagonist
Serine / threonine kinase inhibitor
SGLT inhibitor
Small interfering RNA (siRNA)
Sodium channel blocker
Thrombin inhibitor
TNF-alpha inhibitor
Tyrosine kinase inhibitor
Vasodilator
Virus inhibitor
Budgetting framework
Any budgetting framework
Unknown
Extramural (GVS)
Intermural (MSZ)
Particularity
Any particularity
Unknown
New medicine with Priority Medicines (PRIME)
New therapeutical formulation
Reason of inclusion
New medicines
Indication extensions
IND
Biosimilars / generics
BS
G
Download
ADHD
Lisdexamfetamine
IND
Molindone
ALL
Blinatumomab
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.
IND
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
IND
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.
G
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.
G
autologous anti-CD19-transduced CD3+ cells
IND
ALS
Arimoclomol
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).
G
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).
G
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).
G
Azacitidine
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.
G
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.
G
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.
G
Gilteritinib
Glasdegib
Guadecitabine
Idasanutlin
Imetelstat
Iomab-B
Ivosidenib
Relapsed or refractory isocitrate dehydrogenase-1 (IDH-1) mutation-positive acute myeloid leukaemia
Acute myeloid leukaemia (AML), isocitrate dehydrogenase-1 (IDH1) mutation - first-line combination therapy.
IND
Luspatercept
Sapacitabine
Venetoclax
IND
Aggressive non-Hodgkin?s lymphoma
Brentuximab vedotin
IND
Lisocabtagene maraleucel
Polatuzumab vedotin
Rituximab
IND
Tafasitamab
Tagraxofusp
Zanubrutinib
Allergy
Arachis hypogaea (pinda) allergenen (capsule)
Arachis hypogaea (pinda) allergenen (pleister)
Olopatadine / mometasone
Omalizumab
IND
Antithrombotic medications
Apixaban
G
Dabigatran
G
Dabigatran etexilate
IND
Ravulizumab
IND
Rivaroxaban
IND
Asthma
Beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium
IND
Budesonide / formoterol
IND
Fluticasone furoate / umeclidinium / vilanterol
IND
Indacaterol acetate/glycopyrronium bromide/mometasone furoate
Indacaterol acetate/mometasone furoate
Masitinib
IND
Omalizumab
Aanvullende behandeling om de astmacontrole te verbeteren bij patiënten met ernstig persistent allergisch astma.
BS
Aanvullende behandeling om de astmacontrole te verbeteren bij patiënten met ernstig persistent allergisch astma.
BS
Aanvullende behandeling om de astmacontrole te verbeteren bij patiënten met ernstig persistent allergisch astma. Ook voor de behandeling van chronische idiopathische urticaria.
BS
Bacterial infections
Amoxicilline / omeprazol / rifabutin
Cefiderocol
Ceftaroline fosamil
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).
IND
Extension of indication for the treatment of community acquired pneumonia (CAP) to include concurrent bacteraemia due to Streptococcus pneumoniae (SP) for all age groups.
IND
Ceftazidime / avibactam
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).
IND
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.
IND
Ceftolozaan / tazobactam
IND
Delafloxacin
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.
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.
IND
Delamanid
IND
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.
IND
Lefamulin
Liposomaal amikacine
Obiltoxaximab
Ozenoxacine
Plazomicin
Pretomanid
Tedizolid
Hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), complex bacterial infections, caused by gram positive pathogens
IND
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.
IND
Tigecycline
G
Bipolar disorder
Lumateperone
Lurasidone
IND
Bladder cancer
Atezolizumab
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%.
IND
Adjuvant treatment after surgical resection of high-risk muscle-invasive bladder cancer (MIBC).
IND
Avelumab
IND
Durvalumab
IND
Enfortumab vedotin
Oportuzumab monatox
Pembrolizumab
IND
Ramucirumab
IND
Tremelimumab
IND
Bowel diseases
Adalimumab
IND
Alicaforsen
Pouchitis
Ulcerative colitis
Filgotinib
Remestemcel-L
IND
Tenapanor
Upadacitinib
IND
Brain cancer
Asunercept
Autologous glioma tumor cell lysates
Brain cancer vaccine
Tasadenoturev
Vocimagene amiretrorepvec
Breast cancer
Abemaciclib
IND
Alpelisib
Atezolizumab
Neoadjuvant treatment for patients with early TNBC in combination with nab-paclitaxel.
IND
Treatment of patients with previously untreated metastatic TNBC in combination with paclitaxel.
IND
Margetuximab
Neratinib
IND
Olaparib
IND
Paclitaxel
Palbociclib
Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery.
IND
Patients with HR+/HER2- invasive early breast cancer in combination with standard adjuvant endocrine therapy.
IND
Pembrolizumab
Breast cancer, metastatic, triple negative, 1L.
IND
Tripple Negative Breast Cancer - Neoadjuvant and adjuvant.
IND
Pertuzumab / trastuzumab
Sacituzumab govitecan
Trastuzumab deruxtecan
Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 therapies.
Patients with HER2 low, unresectable, and/or metastatic breast cancer previously treated with 1-2 prior lines of chemotherapy
IND
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.
IND
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.
IND
Trastuzumab entansine in combination with pertuzumab following anthracyclines as adjuvant therapy in patients with operable HER2-positive primary breast cancer.
IND
Tucatinib
Veliparib
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 to the existing chronic lymphocytic leukaemia (CLL) indication to include combination use with obinutuzumab for the treatment of adult patients with previously untreated CLL.
IND
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).
IND
Moxetumomab pasudotox
Ublituximab
Venetoclax
IND
ibrutinib
IND
COPD
Formoterol / glycopyronium / budesonide
Revefenacin
Cardiovascular diseases
Avacopan
Sutimlimab
Colon cancer
Eflornithine / sulindac
Encorafenib
IND
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.
IND
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 .
IND
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.
IND
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
IND
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 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.
IND
Dementia
Aducanumab
Leuco-methylthioninium
Alzheimer’s disease, mild-to-moderate.
Dementia, behavioural variant frontotemporal.
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.
IND
Zuranolone
Diabetes
Canagliflozine
IND
Canagliflozine / metformine
IND
Dapagliflozin / saxagliptin / metformin
Dapagliflozine
Extension of Indication to include type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
IND
Patients With Type 2 Diabetes Mellitus Aged 10 to Below 18 Years Old
IND
Dasiglucagon
Empagliflozine
IND
Exenatide
Finerenone
Glucagon
Insulin aspart
The treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
BS
The treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
BS
Insulin lispro (ultra rapid formulation)
Polyethylene glycol loxenatide
Reparixin
Semaglutide
Sotagliflozine
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.
Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control
IND
Teplizumab
Tirzepatide
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
IND
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.
IND
Cenobamate
Fenfluramine
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.
Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome
IND
Perampanel
IND
Eye disorders
Abicipar
Aflibercept
BS
Aganirsen
Brolucizumab
IND
Faricimab
Latanoprostene bunod
Lenadogene nolparvovec
Lifitegrast
Netarsudil / latanoprost
Polihexanide
Ranibizumab
Wet age-related macular degeneration (AMD).
BS
Wet age-related macular degeneration (AMD).
BS
Wet age-related macular degeneration (AMD).
BS
Wet age-related macular degeneration (AMD).
BS
Treatment of neovascular age-related macular degeneration (AMD)
Reproxalap
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 in combination with tremelimumab
IND
Squamous cell carcinoma of the head and neck, 1L PDL 1.
IND
Leukocyte interleukin
Pembrolizumab
IND
Headache
Eptinezumab
Erenumab
Fremanezumab
Galcanezumab
Lasmiditan
Hearing disorders
Brimapitide
Pioglitazone
Hemostasis promoting medication
Emicizumab
IND
Eptacog beta (activated)
Etranacogene dezaparvovec
Fibrinogen
Fidanacogene elaparvovec
Valoctocogene roxaparvovec
Hodgkin's lymphoma
Pembrolizumab
IND
Hormonal disorders
Levoketoconazole
Linzagolix
Lonapegsomatropin
Macimorelin
Octreotide
Osilodrostat
Relugolix
Patients With Endometriosis-Associated Pain
IND
Treatment of uterine fibroids.
Somapacitan
Somatrogon
Tenapanor
IND
Indolent non-Hodgkin?s lymphoma
Axicabtagene ciloleucel
IND
Copanlisib
Ibrutinib
Follicular lymphoma (FL), relapsed / refractory.
IND
Marginal zone lymphoma (MZL), relapsed / refractory.
IND
Umbralisib
Infectious diseases other
Anidulafungin
IND
Ibrexafungerp
IND
Posaconazol
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.
G
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.
G
Extension of indication to include treatment of invasive aspergillosis in adults
IND
Rezafungin
Kidney cancer
Avelumab
IND
Cabozantinib
IND
Ipilimumab
IND
Pembrolizumab
Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy.
IND
Advanced Renal Cell Carcinoma (1L) in combination with lenvatinib.
IND
Tivozanib
IND
Leukemia
Asciminib
Lipid-lowering medications
Bempedoic acid
Bempedoic acid / ezetimibe
Evinacumab
Inclisiran
Volanesorsen
Liver cancer
Atezolizumab
IND
Pembrolizumab
IND
Pemigatinib
Liver diseases
Givosiran
Maralixibat
Obeticholic acid
IND
Odevixibat
Seladelpar
Lung cancer
Amivantimab
Atezolizumab
For the 1L treatment of patients with metastatic, squamous NSCLC in combination with chemotherapy.
IND
Extension of indication to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours express PD-L1.
IND
Avelumab
IND
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.
IND
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.
IND
Canakinumab
IND
Cemiplimab
IND
Dacomitinib
Durvalumab
Non-small cell lung cancer (NSCLC) stage IV, in combination with tremelimumab and chemo,1L.
Non-small cell lung cancer (NSCLC) stage IV, in combination with chemo, 1L.
IND
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).
IND
1L advanced NSCLC
IND
Completely resected NSCLC
IND
Lokaal gevorderd, niet-resectabel NSCLC (stadium III)
IND
Entrectinib
Lurbinectedin
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.
IND
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.
IND
Osimertinib
IND
Pembrolizumab
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).
IND
Pembrolizumab in Combination with Etoposide/Platinum (Cisplatin or Carboplatin) for the treatmen of extensive stage Small Cell Lung Cancer (SCLC) (1L).
IND
Pralsetinib
Selpercatinib
Sotorasib
Tepotinib
Trilaciclib
Lung other
Ambrisentan
G
Benralizumab
IND
Gefapixant
Mepolizumab
Extension of indication to include Eosinophilic Granulomatosis with Polyangiitis (EGPA) to Nucala
IND
Extension of indication to include Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) for Nucala (mepolizumab).
IND
Molgramostim
Nintedanib
Ofev is indicated in adults for the treatment of systemic sclerosis associated interstitial lung disease.
IND
Ofev is indicated in adults for the treatment of other chronic fibrosing interstitial lung diseases with a progressive phenotype.
IND
Omalizumab
IND
Sarizotan
Mesothelioma
Nivolumab
IND
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
IND
Chenodeoxycholzuur
Elivaldogene autotemcel
Hydrocortisone
Kaliumcitraat / kaliumwaterstofcarbonaat
Lonafarnib
Nitisinone
IND
Olipudase alfa
Pegvaliase
Reloxaliase
Trientine
Vestronidase alfa
Veverimer
Volanesorsen
IND
Multiple Myeloma
Belantamab mafodotin
Carfilzomib
IND
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).
IND
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).
IND
Amyloidose eerstelijnsbehandeling in combinatie met bortezomib, cyclofosfamide en dexamethason.
IND
In combinatie met pomalidomide en dexamethason voor patiënten met multipel myeloom die tenminste een eerdere lijn van behandeling hebben gehad.
IND
Subcutaneous formulation indicates for Relapsed or Refractory Multiple Myeloma.
IND
Multipel myeloom frontline behandeling i.c.m. VRd voor patiënten die niet in aanmerking komen voor een ASCT.
IND
Multipel myeloom frontline behandeling in combinatie met VRd voor patiënten die in aanmerking komen voor een ASCT.
IND
Multipel myeloom frontline onderhoudsbehandeling na DVTd, voor patiënten die in aanmerking komen voor een ASCT.
IND
Smouldering multipel myeloom.
IND
Ibrutinib
IND
Idecabtagene vicleucel
Isatuximab
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.
Combinatie van isatuximab met carfilzomib en dexamethason bij patiënten met gerecidiveerd en refractair multipel myeloom na 1 tot maximaal 3 eerdere behandellijnen.
IND
JNJ-4528
Lenalidomide
IND
Pomalidomide
IND
Selinexor
Zanubrutinib
Multiple sclerosis
Fampridine
G
Fingolimod
G
Masitinib
Natalizumab
Ofatumumab
Ozanimod
Ponesimod
Siponimod
Teriflunomide
IND
Muscular diseases
Sugammadex
G
Muscular diseases other
AMDC-USR
Mexiletine HCl
Myeloproliferative disorders
Fedratinib
Ropeginterferon alfa-2b
Neuroendocrine cancer
Selumetinib
Surufatinib
Neurological disorders other
Buprenorphine
Eculizumab
IND
Eladocagene exuparvovec
Inebilizumab
Remimazolam
Ronopterin
Satralizumab
Oncology other
131I-omburtamab
Dostarlimab
Entrectinib
Glucarpidase
Ivosidenib
IND
Larotrectinib
Lipegfilgrastim
IND
Nivolumab
IND
Pembrolizumab
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.
IND
Advanced Endometrial Cancer (2L+) in combination with lenvatinib.
IND
Locally advanced or metastatic esophageal carcinoma (1L)
IND
Women With Persistent, Recurrent, or Metastatic Cervical Cancer (1L).
IND
Pexidartinib
Sodium thiosulfate
Other chronic immune diseases
Anakinra
IND
Belatacept
IND
Belimumab
IND
Berotralstat
Elobixibat
Emapalumab
Forigerimod
Icatibant
G
Imlifidase
Lanadelumab
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.
IND
Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)
IND
Emiplacel
Empagliflozine
Chronic Heart Failure With Preserved Ejection Fraction (HFpEF).
IND
Extension of indication to include treatment of adult patients with heart failure and reduced ejection fraction for Jardiance
IND
Icosapent ethyl
Regadenoson
IND
Tafamidis
IND
Ticagrelor
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).
IND
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.
IND
Treprostinil
Udenafil
Valsartan / sacubitril
IND
Vericiguat
Other metabolism and Endocrinology
Autologous human chondrocytes in vitro expanded
Dapagliflozine
IND
Elamipretide
Fexapotide
Liraglutide
IND
Lumasiran
Nolasiban
Romosozumab
Semaglutide
IND
Setmelanotide
IND
Vosoritide
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.
IND
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
IND
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.
G
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.
G
Eculizumab
Paroxysmal nocturnal haemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS)
BS
Paroxysmal nocturnal haemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS)
BS
Paroxysmal nocturnal haemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
BS
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.
G
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.
IND
Luspatercept
Mepolizumab
IND
Pegcetacoplan
RP-L102
Ravulizumab
Romiplostim
IND
Roxadustat
Thrombomodulin alfa
Vadadustat
Voxelotor
Ovarian cancer
Atezolizumab
IND
Niraparib
IND
Olaparib
IND
Veliparib
Pain
Bupivacaine
Bupivacaine / meloxicam
Lidocaïne
Neridronic Acid
Tanezumab
Treatment of moderate to severe chronic pain associated with OA of the hip or knee in adult patients for whom treatment with NSAIDs and/or any opioid is ineffective, not tolerated or inappropriate
Chronic Low Back Pain for ≥3 months
IND
Pancreatic cancer
Eryaspase (Asparaginase)
Olaparib
IND
Parkinson's
Amantadine
Apomorphine
Istradefylline
Levodopa / carbidopa
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.
G
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.
G
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.
G
Abiraterone / apalutamide
Apalutamide
IND
Cabazitaxel
G
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.
IND
Enzalutamide
Adult men with metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy.
IND
De behandeling van volwassen mannen met niet-gemetastaseerd hoog risico-CRPC (castratieresistent prostaatcarcinoom).
IND
Niraparib
IND
Olaparib
IND
Relugolix
Rheumatism
Anifrolumab
Filgotinib
Guselkumab
IND
Ixekizumab
IND
Olokizumab
Secukinumab
IND
Tocilizumab
BS
Tofacitinib
Treatment of active polyarticular course juvenile idiopathic arthritis patients 2 years of age and older.
IND
Ankylosing Spondylitis
IND
Upadacitinib
Extension of indication to include the treatment of active ankylosing spondylitis in adult patient for Rinvoq
IND
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.
IND
Ustekinumab
IND
SMA
Onasemnogene abeparvovec
Risdiplam
Schizophrenia, psychosis
Lurasidone
IND
Olanzapine / samidorphan
Skin cancer
Atezolizumab
IND
Cemiplimab
Monotherapy treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.
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.
IND
Dabrafenib / Trametinib
IND
Darleukin fibromun
Lifileucel
Relatlimab
Seviprotimut-L
Spartalizumab
Tavokinogene telseplasmid
Skin diseases
Abrocitinib
Baricitinib
IND
Beremagene geperpavec
Berkenschorsextract
IND
Bimekizumab
Clascoterone
Crisaborole
Difelikefalin
Dupilumab
IND
Glycopyrronium tosylate
Ixekizumab
IND
Lebrikizumab
Nemolizumab
Secukinumab
IND
Tapinarof
Adult Plaque Psoriasis
Atopische dermatitis
Tirbanibulin
Tralokinumab
Trifarotene
Upadacitinib
IND
Sleep disorders
JZP-258
Lemborexant
Natriumoxybaat
IND
Solriamfetol
Tasimelteon
IND
Stem cell transplants
Axicabtagene ciloleucel
IND
BL-8040
Ibrutinib
IND
Inolimomab
Itacitinib
Narsoplimab
Omidubicel
Remestemcel-L
Rimiducid
Rivogenlecleucel
Ruxolitinib
IND
Tabelecleucel
Thiotepa
G
autologous anti-CD19-transduced CD3+ cells
Stomach cancer
Avapritinib
Masitinib
Ripretinib
Rivoceranib
Trastuzumab deruxtecan
IND
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
Bulevirtide
Cabotegravir
Dapagliflozine
IND
Dexamethasone
IND
Etravirine
IND
Fostemsavir
Glecaprevir / pibrentasvir
IND
Human normal immunoglobulin
IND
Ibalizumab
Maribavir
Remdesivir
Tecovirimat
Zanamivir
Naar boven
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