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Mercaptamine

Cystadrops

Extended indication Extension of indication to include treatment of children from 6 months of age with paediatric cystinosis
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Mercaptamine
Domain Metabolism and Endocrinology
Reason of inclusion Indication extension
Main indication Eye disorders
Extended indication Extension of indication to include treatment of children from 6 months of age with paediatric cystinosis
Proprietary name Cystadrops
Manufacturer Recordati
Route of administration Ocular
Therapeutical formulation Eye drops
Budgetting framework Extramural (GVS)
Additional remarks Mercaptamine kan neerslagen van cystine in de cornea verminderen. Dit betreft de indicatieuitbreiding voor 6 maanden tot 2 jaar.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date November 2024
Expected Registration September 2025
Orphan drug Yes
Registration phase Registration application pending
Additional remarks Verwachte registratie op basis van gemiddelde doorlooptijd van 10 maanden voor een indicatieuitbreiding.

Therapeutic value

Therapeutic value No estimate possible yet
Duration of treatment continuous
Frequency of administration 4 times a day
Dosage per administration 1 druppel in ieder oog
References NCT04125927 (CYT-C2-00)

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 43,728.00 - 45,117.00
References GIPdatabank
Additional remarks Van 2019 t/m 2023 was de gemiddelde vergoeding per gebruiker Cystadrops €43.728-€45.117.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.