EMEA-002012-PIP01-16-M03

Table of contents

Key facts

Invented name
Namuscla
Active substance
Mexiletine hydrochloride
Therapeutic area
Other
Decision number
P/0365/2021
PIP number
EMEA-002012-PIP01-16-M03
Pharmaceutical form(s)
  • Capsule, hard
  • Oral solution
Condition(s) / indication(s)
Treatment of myotonic disorders
Route(s) of administration
  • Oral use
  • Gastric use
Contact for public enquiries
Lupin Europe GmbH

Tel.  +41 526337025
E-mail: behruzeslami@lupin.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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