EMEA-001850-PIP01-15 - paediatric investigation plan

Inactivated poliovirus type 1 (Brunhilde)Inactivated poliovirus type 2 (MEF-1)Inactivated poliovirus type 3 (Saukett)

Key facts

• Active Substance:
  Inactivated poliovirus type 1 (Brunhilde)Inactivated poliovirus type 2 (MEF-1)Inactivated poliovirus type 3 (Saukett)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0320/2015
• PIP number:
  EMEA-001850-PIP01-15
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of poliomyelitis
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  Statens Serum Institut

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  21/12/2015

Decision

P/0320/2015: EMA decision of 21 December 2015 on the granting of a product-specific waiver for inactivated poliovirus type 1 (Brunhilde), inactivated poliovirus type 2 (MEF-1),inactivated poliovirus type 3 (Saukett) (EME...

AdoptedReference Number: EMA/792006/2015