Neurological disorders

ADHD

• Guanfacine ^G

• Lisdexamfetamine

  • Elvanse Adult is geïndiceerd als onderdeel van een uitgebreid behandelingsprogramma voor ADHD bij volwassenen.
  • Kinderen en jongeren tussen 6 en 18 jaar die eerder een behandeling met methylfenidaat kregen, waarmee hun ADHD onvoldoende behandeld werd.

• Melatonine

  • Sleep disorders and daily rhythm disorders in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD).
• Molindone

ALS

• Arimoclomol

  • Amyotropic Lateral Sclerosis
• Edaravone
• Gold Nanocrystals
• Ibudilast
• Lenzumestrocel

• Masitinib

  • Amyotrophic lateral sclerosis (ALS), add on in patients on a stable dose of riluzole.

• Pridopidine

  • Amyotrophic lateral sclerosis (ALS)
• Reldesemtiv
• Sodium phenylbutyrate / ursodoxicoltaurine
• Tofersen

Bipolar disorder

• Lurasidone

  • Bipolar depression, as monotherapy and adjunct treatment.

Dementia

• Aducanumab
• Blarcamesine
• Donanemab
• Gantenerumab
• Hydromethylthionine mesylaat
• Lecanemab

• Leuco-methylthioninium

  • Dementia, behavioural variant frontotemporal.
• NE3107
• Valiltramiprosate

Depression

• Agomelatine ^IND
• Brexanolone
• Bupropion / dextromethorphan

• 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® (esketamine nasal spray) co-administered with oral antidepressant therapy in adults with a moderate to severe episode of Major Depressive Disorder (MDD), as acute short term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.
• Psilocybine
• Seltorexant
• Zuranolone

Duchenne

• Ataluren ^G
• Casimersen
• Delandistrogene moxeparvovec
• Delpacibart zotadirsen
• Deramiocel
• Edasalonexent
• Fordadistrogene movaparvovec

• Givinostat

  • Duvyzat is indicated for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment
• Golodirsen

• 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

• Vamorolone

  • Agamree is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older
  • Extension of indication to include treatment of 2 to <4 year olds with Duchenne muscular dystrophy (DMD)
• Viltolarsen

Epilepsy

• Bexicaserin
• Brivaracetam ^IND

• 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.
  • Epidyolex is indicated for use as adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC) for patients 2 years of age and older.
  • Extension of indication to include treatment with Epidyolex (monotherapy) as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS) for patients 2 years of age and older (without the restriction for use only in conjunction with clobazam.
• Cenobamaat
• Diazepam nasaal

• Fenfluramine

  • Extension of indication to include treatment of seizures associated with Lennox-Gastaut syndrome as an add on therapy to other anti-epileptic medicines for patients 2 years of age and older.
  • 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.
• Ganaxolone
• Lacosamide ^IND
• Midazolam ^IND
• Opakalim
• Perampanel ^IND
• Pregabalin ^IND
• Vigabatrin
• Zonisamide ^IND

Eye disorders

• Abicipar
• Acoltremon

• Aflibercept

  • Aflibercept monotherapy for first line treatment of Macular oedema in adults and elderly secondary to retinal vein occlusion.
  • Eylea is indicated in preterm infants for the treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or AP-ROP (aggressive posterior ROP) disease.
  • Diabetic macular edema
• Aganirsen
• Atropine sulfate ^IND
• Avacincaptad pegol
• Bevacizumab-vikg ^BS
• Bimatoprost
• Botaretigene sparoparvovec
• Brimonidine tartrate/carbachol

• Brolucizumab

  • Treatment of neovascular (wet) age-related macular degeneration (AMD)
  • Extension of indication to include treatment of visual impairment due to diabetic macular oedema (DME)
• Cenegermin

• Ciclosporin

  • Keratoconjunctivitis sicca (or dry eye disease), moderate-to-severe and specifically in patients with atopic keratoconjunctivitis.
  • Treatment of severe vernal keratoconjunctivitis in children from 4 years of age and adolescents.

• Ciclosporine

  • Treatment of moderate to severe dry eye disease (keratoconjuctivitis sicca) in adult patients, which has not improved despite treatment with tear substitutes.
• Citicoline
• Diclofenamide ^G

• Faricimab

  • Extension of indication to include treatment of adult patients with visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).
  • Treatment of neovascular (wet) age-related macular degeneration (nAMD).
  • Treatment of visual impairment due to diabetic macular oedema (DME).
• IBI311

• KPI-121

  • Ocular pain and inflammation. Om te gebruiken na oogchirurgie.
  • Dry eye disease.
• Laruparetigene zosaparvovec
• Latanoprostene bunod
• Lenadogene nolparvovec
• Lifitegrast

• Mercaptamine

  • Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 6 months of age with cystinosis.
• Midazolam/ketamine
• Netarsudil / latanoprost
• Netarsudil mesylate
• OCU400

• Pegcetacoplan

  • Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
• Perfluorohexyloctane
• Phentolamine
• Polihexanide
• RGN-259

• Ranibizumab

  • Lucentis is geïndiceerd voor gebruik bij premature baby’s voor de behandeling van premature retinopathie (retinopathy of prematurity, ROP) met zone I (stadium 1+, 2+, 3 of 3+), zone II (stadium 3+) of AP-ROP (agressieve posterieure ROP) ziekte.
  • Lucentis is geïndiceerd voor gebruik bij volwassenen voor de behandeling van proliferatieve diabetische retinopathie (PDR).
  • Wet age-related macular degeneration (AMD).
  • 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

  • Moderate to severe dry eye disease
  • Allergic conjunctivitis
• Revakinagene Taroretcel
• Ripasudil
• Sepofarsen
• Sonpiretigene Isteparvovec
• Tarcocimab tedromer
• Timbetasine acetaat
• Timrepigene emparvovec
• Tinlarebant
• Tivanisiran
• Varenicline
• Voretigene neparvovec

Headache

• Atogepant

  • Aquipta is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.
  • Acute Migraine in adults
• Dihydroergotamine

• Eptinezumab

  • Vyepti is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.
  • Eptinezumab monotherapy for preventive treatment of Chronic migraine in children over 6 years of age and adolescents with or without aura.
• Erenumab

• Fremanezumab

  • Indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.
  • Fremanezumab monotherapy for preventive treatment of Chronic migraine, Episodic migraine in children over 6 years of age and adolescents.

• Galcanezumab

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

• Rimegepant

  • Acute treatment of migraine with or without aura in adults
  • VYDURA is indicated for the acute treatment of migraine with or without aura in adults and preventive treatment of episodic migraine in adults who have at least 4 migraine attacks per month.
  • Preventive treatment of episodic migraine in adults who have at least 4 migraine attacks per month

Hearing disorders

• Brimapitide
• Pioglitazone

Multiple sclerosis

• Biotin
• Cladribine

• Dimethyl fumarate

  • Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).
  • Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).
  • Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
  • Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).
• Diroximel fumarate
• Fampridine ^G

• Fingolimod

  • Enkelvoudige ziekte modificerende therapie bij zeer actieve relapsing remitting multiple sclerose in de volgende groepen van volwassen patiënten en pediatrische patiënten van 10 jaar en ouder: -Patiënten met zeer actieve ziekte ondanks een volledige en adequate behandeling met ten minste één ziekte modificerend middel. -Patiënten met zich snel ontwikkelende ernstige relapsing/remitting multiple sclerose, gedefinieerd door 2 of meer invaliderende schubs in één jaar en met 1 of meer gadolinium aankleurende laesies op de hersen-MRI of een significante toename van de lading van T2-laesies in vergelijking met een eerdere recente MRI.
  • Enkelvoudige ziekte modificerende therapie bij zeer actieve relapsing remitting multiple sclerose in de volgende groepen van volwassen patiënten en pediatrische patiënten van 10 jaar en ouder: -Patiënten met zeer actieve ziekte ondanks een volledige en adequate behandeling met ten minste één ziekte modificerend middel. -Patiënten met zich snel ontwikkelende ernstige relapsing/remitting multiple sclerose, gedefinieerd door 2 of meer invaliderende schubs in één jaar en met 1 of meer gadolinium aankleurende laesies op de hersen-MRI of een significante toename van de lading van T2-laesies in vergelijking met een eerdere recente MRI.
  • Fingolimod is geïndiceerd als enkelvoudige ziektemodificerende therapie bij zeer actieve relapsing-remitting multiple sclerose in de volgende volwassen patiëntengroepen en pediatrische patiënten vanaf de leeftijd 10 jaar en ouder: Patiënten met zeer actieve ziekte ondanks een volledige en adequate behandeling met ten minste één ziektemodificerend middel of 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

  • actieve relapsing-remitting multiple sclerose (zie indicatie huidige spécialité).
  • TYSABRI is geïndiceerd als enkelvoudige ziekte modificerende therapie bij volwassenen met zeer actieve relapsing-remitting multiple sclerose in de volgende patiëntengroepen: • Patiënten met zeer actieve ziekte ondanks een volledige en adequate behandeling met ten minste één ziekte modificerende therapie (disease modifying therapy, DMT) of • Patiënten met zich snel ontwikkelende ernstige relapsing-remitting multiple sclerose, gedefinieerd door 2 of meer invaliderende relapses 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.

• Ocrelizumab

  • Volwassen patiënten met actieve relapsing multiple sclerose (RMS) die is gedefinieerd door klinische of beeldvormende kenmerken.
  • Volwassen patiënten met vroege primair progressieve multiple sclerose (PPMS) gebaseerd op de ziekteduur, mate van invaliditeit en beeldvormende kenmerken die typerend zijn voor ontstekingsactiviteit.
• Ofatumumab

• Ozanimod

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

• Teriflunomide

  • Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).
  • Aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis.
  • Volwassenen met 'relapsing remitting' multipele sclerose (RRMS).
• Tolebrutinib

• Ublituximab

  • Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features

Muscular diseases

• Botulinum A toxin

  • Lower limb spasticity (LLS), post stroke.

• Eculizumab

  • Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive.
• Eteplirsen

• Nusinersen

  • Behandeling van 5q spinale spieratrofie (spinal muscular atrophy, SMA).
• Valbenazine

Muscular diseases other

• Amifampridine ^G
• Baclofen / naltrexone / sorbitol
• Bidridistrogene xeboparvovec

• Botulinum A toxin

  • Lower limb spasticity (LLS), in adults post stroke or traumatic brain injury (TBI).
• Condoliase
• Dantroleen ^G
• Daxibotulinumtoxine A
• Di-deuterated ethyl linoleate
• Doxecitine / doxiribtimine

• Eculizumab

  • Extension of indication to include treatment of paediatric patients aged 6 years and above with acetylcholine receptor-antibody (AChR-Ab) positive (+) refractory gMG.
  • Extension of indication to include treatment of paediatric patients with refractory generalised myasthenia gravis (gMG).

• Efgartigimod

  • Vyvgart is geïndiceerd als een aanvulling op de standaardtherapie voor de behandeling van volwassen patiënten met gegeneraliseerde myasthenia gravis (gMG) die positief testen op antilichamen tegen acetylcholinereceptoren (AChR).
• Empasiprubart
• Incobotulinumtoxina

• Inebilizumab

  • Inebilizumab monotherapy for treatment of myasthenia gravis in adults and elderly with anti-AChR or anti-MuSK antibody.
• Kyv-101
• Losmapimod
• Mexiletine ^IND
• Mexiletine HCl
• Nipocalimab
• Omaveloxolon

• Ravulizumab

  • Ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody-positive.
• Rozanolixizumab ^IND

• Satralizumab

  • Generalized Myasthenia

• Sugammadex

  • Extension of indication to include treatment the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in paediatric patients from birth to 17 years.
  • Opheffing van een door rocuronium geïnduceerd neuromusculair blok bij: Volwassenen: voor onmiddellijke opheffing en voor de zogenaamde. 'standaardopheffing'; Kinderen: standaardopheffing.
• Tanruprubart
• Vatiquinone
• Zilucoplan

Neurological disorders other

• ABBV-8E12

• Botulinum A toxin

  • Nuceiva is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.
  • Chronic sialorrhoea in adults and children, associated with neurological conditions (Parkinson’s Disease (PD), stroke, traumatic brain injury (TBI), cerebral palsy (CP).

• 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.
• CM-AT / CM-4612

• Cannabidiol

  • Children and Adolescents With Fragile X Syndrome aged 3 to < 18 years.
• Clazosentan
• Deutetrabenazine (extended release)

• Dexmedetomidine

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

• 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.
• Efgartigimod alfa ^IND
• Eladocagene exuparvovec
• Eplontersen

• Esketamine

  • Tinnitus
• Gefurulimab
• Glycopyrronium ^IND

• Human normal immunoglobulin

  • Extension of indication to include treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg for adults, children and adolescents (0 to 18 years).

• Inebilizumab

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

• Natriumoxybaat

  • Medium to long-term maintenance of alcohol abstinence and treatment of mild to moderate alcohol withdrawal syndrome
• Nepla-tem-cel
• Patisiran

• Pridopidine

  • Early stage Huntington Disease.

• Ravulizumab

  • voor de behandeling van volwassen patiënten met NMOSD die positief zijn voor antilichamen tegen aquaporine-4 (AQP4)
• Remimazolam
• Ronopterin

• Satralizumab

  • Patiënten met neuromyelitis optica‑spectrumstoornissen (NMOSD), die seropositief zijn voor anti-aquaporine-4-IgG (AQP4-IgG) (vanaf 12 jaar).

• Tiratricol

  • Emcitate is indicated for the treatment of peripheral thyrotoxicosis in patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley Syndrome), from birth.
  • Treatment of monocarboxylate transporter 8 (MCT8) deficiency
• Trofinetide
• Troriluzole
• Ulixacaltamide

• Vutrisiran

  • Treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
  • Extension of indication to include treatment of wild-type or hereditary transthyretin-mediated amyloidosis in adult patients with cardiomyopathy (ATTR-CM)
• Zilganersen

Other psychiatry

• Dexmedetomidine

  • Agitation in Schizophrenia, Bipolar Disorder
• Soclenicant
• Troriluzol

Pain

• Adezunap
• Basimglurant

• 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
  • Extension of indication to include children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.
• Bupivacaine / meloxicam
• Buprenorfine ^IND
• Chloroprocaine ^IND
• Difluprednate
• Fasinumab
• Lidocaïne
• Neridronic Acid
• Oxycodon ER
• Sufentanil / ketamine

• 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

Parkinson's

• Amantadine
• Apomorphine
• Ioflupane (123I) ^G
• Istradefylline
• Levodopa

• Levodopa / carbidopa

  • Levodopa/carbidopa monotherapy for treatment of Parkinson's disease in adults over 30 years of age and elderly who are experiencing motor fluctuations.
  • Parkinson
• Pimavanserin

Psychiatry

• Cariprazine

  • Schizofrenie bij volwassenen.
  • Bipolaire depressie

SMA

• Apitegromab

• Nusinersen

  • Nusinersen monotherapy for treatment of 5q Spinal muscular atrophy in newborns, infants, toddlers, children, adolescents and adults administered at a higher dose

• Onasemnogene abeparvovec

  • Patients up to 18 years of age with 5q spinal muscular atrophy (SMA) SMA type 1, 2 and 3 or with 1-4 copies of the SMN2-gene.
  • 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

  • Extension of indication to include treatment of patients below 2 months of age.
  • 5q SMA in patients 2 months of age and older, with a clinical diagnosis of Type 1, Type 2 or Type 3 SMA or with one to four SMN2 copies.

Schizophrenia, psychosis

• Brexpiprazole

• Lurasidone

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

Schizophrenia, psychosis, bipolar disorder

• Brexpiprazol ^IND
• Cycloserine / lurasidon
• Iloperidon
• Lumateperone
• Olanzapine (long-acting injectable)
• Roluperidon
• Xanomeline / trospium

Sleep disorders

• Daridorexant
• JZP-258
• Lemborexant
• Melatonin

• Melatonine

  • Extension of indication for the treatment of insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient.

• Natriumoxybaat

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

• Pitolisant

  • Ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by, or who have not tolerated, OSA primary therapy, such as continuous positive airway pressure (CPAP).
  • Extension of indication to include treatment of narcolepsy with or without cataplexy in adolescents and children from the age of 6 years.
• Solriamfetol

• Tasimelteon

  • Extension of indication to include the treatment of nighttime sleep disturbances in adults with Smith Magenis Syndrome (SMS).
  • Jet lag disorder
  • Behandeling van volledig blinde volwassenen met niet-24-uurs slaap-waakstoornis (N24HSWD).

• Tirzepatide

  • Extension of indication to include, as an adjunct to diet and exercise, the treatment of moderate to severe obstructive sleep apnoea (OSA) in adults with obesity.