EMEA-002012-PIP01-16-M05 - paediatric investigation plan
Mexiletine hydrochloride
PIPHuman
Key facts
- Invented name
- Namuscla
- Active Substance
- Mexiletine hydrochloride
- Therapeutic area
- Nervous system disorders
- Decision number
- P/0227/2024
- PIP number
- EMEA-002012-PIP01-16-M05
- Pharmaceutical form(s)
- Capsule, hard
- Oral solution
- Condition(s) / indication(s)
- Treatment of myotonic disorders
- Route(s) of administration
- Oral use
- Contact for public enquiries
Lupin Europe GmbH
Tel. +44 1565751378
E-mail: preetamathur@lupin.com- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date