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Mexiletine HCl

Namuscla

Extended indication Symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.
Therapeutic value No judgement
Registration phase Positive CHMP opinion

Product

Active substance Mexiletine HCl
Domain Neurological disorders
Reason of inclusion New medicine (specialité)
Main indication Muscular diseases
Extended indication Symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.
Proprietary name Namuscla
Manufacturer Lupin
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)
Additional remarks Toedieningsvorm: naast capsules komt mexiletine HCl ook als oplossing beschikbaar (bron EMA).

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date September 2017
Expected Registration December 2018
Orphan drug Yes
Registration phase Positive CHMP opinion
Additional remarks Mexiletine HCl is al op de markt in Frankrijk. Positieve CHMP-opinie oktober 2018.

Therapeutic value

Therapeutic value No judgement
Duration of treatment continuous
Frequency of administration 3 times a day
Dosage per administration 150 mg
References NCT01406873

Expected patient volume per year

References EMA
Additional remarks EMA: 2 in 10.000 inwoners in de EU. Dit betreft maximaal zo'n 3.400 patiënten in Nederland.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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
References SPS

Other information

There is currently no futher information available.