EMEA-001628-PIP01-14 - paediatric investigation plan

antisense oligonucleotide (30-mer) with nucleotide sequence 5′-GTAATTGCGGCAAGAAGAATTGTTTCTGTC-3′(CODA001)

Key facts

• Active substance:
  antisense oligonucleotide (30-mer) with nucleotide sequence 5′-GTAATTGCGGCAAGAAGAATTGTTTCTGTC-3′(CODA001)
• Therapeutic area:
  Dermatology
• Decision number:
  P/0233/2014
• PIP number:
  EMEA-001628-PIP01-14
• Pharmaceutical form(s):
  Gel
• Condition(s) / indication(s):
  Treatment of venous leg ulcer
• Route(s) of administration:
  Epilesional use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  05/09/2014
• Compliance check done:
  No

Decision

P/0233/2014: EMA decision of 5 September 2014 on the granting of a product specific waiver for antisense oligonucleotide (30-mer) with nucleotide sequence 5”²-GTAATTGCGGCAAGAAGAATTGTTTCTGTC-3”²(CODA001) (EMEA-001628-PIP0...

Adopted Reference Number: EMA/469204/2014