MHRA-100706-PIP01-22

Key Facts

Active Substance
Active Substance:
  • METHYLPHENIDATE HYDROCHLORIDE
Invented Name
  • Not available at present
  • Methylphenidate hydrochloride
  • Methylphenidate hydrochloride
  • Methylphenidate hydrochloride
  • Methylphenidate hydrochloride
PIP Number MHRA-100706-PIP01-22
Pharmaceutical form(s)
  • Chewable tablet
  • Oral suspension
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of attention-deficit hyperactivity disorder
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • LABORATORIOS LESVI, S.L.
  • Country Spain
  • Tel 0034936022404
  • Email info@lesvi.es
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-100706-PIP01-22-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):METHYLPHENIDATE HYDROCHLORIDE.pdf
Published Date 30/06/2023