EMEA-002927-PIP02-21 - paediatric investigation plan

Adalimumab conjugated with (4S)-4-[2-(2-bromoacetamido)acetamido]-5-{3-[(4-{(4aR,4bS,5S,6aS,6bS,8R,9aR,10aS,10bS)-5-hydroxy-4a,6a-dimethyl-2-oxo-6b-[(phosphonooxy)acetyl]-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H,8H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8-yl}phenyl)methyl] anilino}-5-oxopentanoic acid; ABBV-154

Key facts

• Active Substance:
  Adalimumab conjugated with (4S)-4-[2-(2-bromoacetamido)acetamido]-5-{3-[(4-{(4aR,4bS,5S,6aS,6bS,8R,9aR,10aS,10bS)-5-hydroxy-4a,6a-dimethyl-2-oxo-6b-[(phosphonooxy)acetyl]-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H,8H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8-yl}phenyl)methyl] anilino}-5-oxopentanoic acid; ABBV-154
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0124/2022
• PIP number:
  EMEA-002927-PIP02-21
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of polymyalgia rheumatica
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  AbbVie Ltd

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  15/04/2022

Decision

P/0124/2022 : EMA decision of 15 April 2022 on the granting of a product-specific waiver for adalimumab conjugated with (4S)-4-[2-(2- bromoacetamido)acetamido]-5-{3-[(4-{(4aR,4bS,5S,6aS,6bS,8R,9aR,10aS,10bS)....(EMEA-002927-PIP02-21)

AdoptedReference Number: EMA/149061/2022