EMEA-001761-PIP01-15 - paediatric investigation plan

hydrochlorothiazide

nebivolol (hydrochloride)

Key facts

• Active Substance:
  • hydrochlorothiazide
  • nebivolol (hydrochloride)
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0200/2015
• PIP number:
  EMEA-001761-PIP01-15
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of hypertension
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Actavis Group PTC ehf

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/09/2015

Decision

P/0200/2015: EMA decision of 4 September 2015 on the granting of a product-specific waiver for hydrochlorothiazide / nebivolol (hydrochloride) (EMEA-001761-PIP01-15)

AdoptedReference Number: EMA/571076/2015