EMEA-002927-PIP01-20
Table of contents
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/0454/2021
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| PIP number |
EMEA-002927-PIP01-20
|
| Pharmaceutical form(s) |
Solution for injection (in pre-filled syringe)
|
| Condition(s) / indication(s) |
Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)
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| Route(s) of administration |
Subcutaneous use
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| Contact for public enquiries |
AbbVie Ltd
Tel.: +44 1628408248 |
| Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
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