EMEA-002239-PIP01-17 - paediatric investigation plan

rosuvastatin calcium

Acetylsalicylic acid

Key facts

• Active Substance:
  • rosuvastatin calcium
  • Acetylsalicylic acid
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0039/2018
• PIP number:
  EMEA-002239-PIP01-17
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Prevention of cardiovascular events
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Adamed Sp. z o.o.

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/02/2018

Decision

P/0039/2018: EMA decision of 16 February 2018 on the granting of a product specific waiver for rosuvastatin (calcium) / acetylsalicylic acid (EMEA- 002239-PIP01-17)

Reference Number: EMA/850787/2017