EMEA-001396-PIP01-12 - paediatric investigation plan

Clostridium botulinum toxin type A, purified neurotoxin

Key facts

• Active Substance:
  Clostridium botulinum toxin type A, purified neurotoxin
• Therapeutic area:
  Dermatology
• Decision number:
  P/0120/2013
• PIP number:
  EMEA-001396-PIP01-12
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of skin dystrophies
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  Janssen Biologics B.V.

  The Netherlands; [e-mail] ; Tel. [phone]; Fax [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/05/2013

Decision

P/0120/2013: EMA decision of 3 May 2013 on the granting of a product-specific waiver for Clostridium botulinum toxin type A, purified neurotoxin (EMEA-001396-PIP01-12)

AdoptedReference Number: EMA/202092/2013