EMEA-002259-PIP01-17 - paediatric investigation plan

Levothyroxine (sodium)

Key facts

• Active Substance:
  Levothyroxine (sodium)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0096/2018
• PIP number:
  EMEA-002259-PIP01-17
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  • Treatment of benign thyroid nodules
  • Treatment of goitre
  • Treatment of hypothyroidism
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  IBSA Institut Biochimique SA

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/03/2018

Decision

P/0096/2018: EMA decision of 16 March 2018 on the granting of a product- specific waiver for levothyroxine (sodium) (EMEA-002259-PIP01-17)

AdoptedReference Number: EMA/91880/2018