Mexiletine HCl

Extended indication	Myotonic disorders.
Therapeutic value	No judgement

Product

Active substance	Mexiletine HCl
Domain	Neurological disorders
Main indication	Muscular diseases
Extended indication	Myotonic disorders.
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 route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	September 2017
Expected Registration	July 2018
Orphan drug	Yes
Additional remarks	Mexiletine hcl is al op de markt in Frankrijk.

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

Patient volume	< 3,400 Market share is generally not included unless otherwise stated.
References	EMA
Additional remarks	EMA: 2 in 10.000 inwoners in de EU.

Patient volume

< 3,400

Market share is generally not included unless otherwise stated.

References

EMA

Additional remarks

EMA: 2 in 10.000 inwoners in de EU.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.