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Olopatadine / mometasone

Ryaltris

Extended indication Ryaltris is indicated in adults and children 12 years of age and older for the treatment of nasal an
Therapeutic value Possible equal value
Registration phase Registered

Product

Active substance Olopatadine / mometasone
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Extended indication Ryaltris is indicated in adults and children 12 years of age and older for the treatment of nasal and ocular symptoms associated with allergic rhinitis and rhino-conjunctivitis
Proprietary name Ryaltris
Manufacturer Glenmark
Mechanism of action Combination therapy
Route of administration Nasal
Therapeutical formulation Nose spray
Budgetting framework Extramural (GVS)
Additional remarks Antihistamine (oloparatide) en corticosteroïd (mometasone). Scrip pipeline watch 18 dec 2017: Efficacy and safety endpoints met.

Registration

Registration route Decentralised
Submission date January 2020
Expected Registration August 2021
Orphan drug No
Registration phase Registered
Additional remarks Het geneesmiddel is ingediend bij de FDA, maar niet in behandeling genomen vanwege onbekende onvolkomenheden in de aanvraag.

Therapeutic value

Current treatment options Anti-histaminica, corticosteroiden.
Therapeutic value Possible equal value
Duration of treatment Average 120 day / days
Frequency of administration 2 times a day
Dosage per administration 665 μg / 25 μg
References NCT02709538; GIPdatabank
Additional remarks Gebruik wanneer nodig. Tweemaal sprayen per toediening dus 4 doses per dag.

Expected patient volume per year

References NHG-Standaard Allergische en niet-allergische rhinitis
Additional remarks In huisartsenregistraties is de prevalentie van allergische en niet-allergische rhinitis 25 per 1.000 mannen en 31 per 1.000 vrouwen per jaar. Dit komt neer op 391.000 per 17 miljoen Nederlanders. Olopatadine/mometasone zal hier een klein deel van de markt van kunnen veroveren.

Expected cost per patient per year

Cost 700.00 - 800.00
References Medicijnkosten.nl; GIPdatabank
Additional remarks 1 flacon mometasone 140 doses, 50 μg/dosis kost €5,45; 1 flacon van 5ml, 1mg/ml olopatadine oogdruppels kost €7,32; Mometason (Nosonex) wordt gemiddeld per gebruiker voor 90 DDD (Daily Defined Dose) gebruikt.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No

Other information

There is currently no futher information available.