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Keyword adalimumab Remove keyword
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Human medicine European public assessment report (EPAR): Hefiya
adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis
Date of authorisation: 26/07/2018,
, Revision: 12, Authorised, Last updated: 18/04/2023
Authorised adalimumab Overview Hefiya is a medicine … medicine. active substance adalimumab and is a ‘ A medicine that … active substance in Hefiya, adalimumab, is a monoclonal antibody … -
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Human medicine European public assessment report (EPAR): Hyrimoz
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous
Date of authorisation: 26/07/2018,, Revision: 11, Authorised, Last updated: 17/04/2023
adalimumab … EMEA/H/C/004320 Hyrimoz (adalimumab) An overview of Hyrimoz … contains the active substance adalimumab and is a ‘biosimilar medicine’ … -
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Human medicine European public assessment report (EPAR): Imraldi
adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis
Date of authorisation: 24/08/2017,, Revision: 20, Authorised, Last updated: 24/03/2023
adalimumab … Imraldi; INN-adalimumab 30 Churchill Place … for the public Imraldi adalimumab This is a summary of the … -
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Human medicine European public assessment report (EPAR): Hukyndra
adalimumab, Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Hidradenitis Suppurativa; Psoriasis; Spondylitis, Ankylosing; Uveitis
Date of authorisation: 15/11/2021,, Revision: 4, Authorised, Last updated: 09/03/2023
Authorised adalimumab Overview Hukyndra is a medicine … medicine. active substance adalimumab. How is Hukyndra used … have experience of using adalimumab. For more information about … -
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Human medicine European public assessment report (EPAR): Yuflyma
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 11/02/2021,, Revision: 9, Authorised, Last updated: 30/01/2023
adalimumab … EMEA/H/C/005188 Yuflyma (adalimumab) An overview of Yuflyma … contains the active substance adalimumab. Yuflyma adalimumab) EMA/705248/2020 Page … -
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Human medicine European public assessment report (EPAR): Amgevita
adalimumab, Arthritis, Psoriatic; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 21/03/2017,, Revision: 11, Authorised, Last updated: 18/01/2023
adalimumab … Amgevita, INN-adalimumab 30 Churchill Place … for the public Amgevita adalimumab This is a summary of the … -
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Human medicine European public assessment report (EPAR): Libmyris
adalimumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Psoriasis; Hidradenitis Suppurativa; Crohn Disease; Colitis, Ulcerative; Uveitis
Date of authorisation: 12/11/2021,, Revision: 1, Authorised, Last updated: 11/01/2023
Authorised adalimumab Overview Libmyris is a medicine … medicine. active substance adalimumab. How is Libmyris used? Libmyris … have experience of using adalimumab. For more information about … -
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Human medicine European public assessment report (EPAR): Hulio
adalimumab, Hidradenitis Suppurativa; Psoriasis; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Arthritis, Psoriatic
Date of authorisation: 17/09/2018,
, , Revision: 13, Authorised, Last updated: 05/12/2022
adalimumab … EMEA/H/C/004429 Hulio (adalimumab) An overview of Hulio and … contains the active substance adalimumab and is a ‘biosimilar medicine’ … -
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Human medicine European public assessment report (EPAR): Humira
adalimumab, Spondylitis, Ankylosing; Arthritis, Juvenile Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 08/09/2003, Revision: 89, Authorised, Last updated: 16/12/2022Authorised adalimumab Overview Humira is a medicine … medicine. active substance adalimumab. How is Humira used? Humira … active substance in Humira, adalimumab, is a monoclonal antibody … -
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Human medicine European public assessment report (EPAR): Idacio
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 02/04/2019,, , Revision: 10, Authorised, Last updated: 18/10/2022
adalimumab … syringe contains 40 mg of adalimumab. Idacio 40 mg solution for … pre-filled pen contains 40 mg of adalimumab. Adalimumab is a recombinant human monoclonal … -
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Human medicine European public assessment report (EPAR): Amsparity
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 13/02/2020,, , Revision: 4, Authorised, Last updated: 29/10/2021
adalimumab … syringe contains 20 mg of adalimumab. Adalimumab is a recombinant human monoclonal … monotherapy see section 5.1). Adalimumab has not been studied in patients … -
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Human medicine European public assessment report (EPAR): Halimatoz
adalimumab, Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic
Date of authorisation: 26/07/2018,, , Revision: 8, Withdrawn, Last updated: 29/01/2021
adalimumab … authorisation for Halimatoz (adalimumab) in the European Union (EU … EMEA/H/C/004866 Halimatoz (adalimumab) An overview of Halimatoz … -
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Human medicine European public assessment report (EPAR): Kromeya
adalimumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Psoriasis; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Colitis, Ulcerative; Crohn Disease
Date of authorisation: 02/04/2019,, , Revision: 4, Withdrawn, Last updated: 25/03/2020
adalimumab … Kromeya adalimumab adalimumab … -
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Human medicine European public assessment report (EPAR): Cyltezo
adalimumab, Hidradenitis Suppurativa; Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 10/11/2017,, , Revision: 2, Withdrawn, Last updated: 06/03/2019
adalimumab … Cyltezo adalimumab adalimumab … -
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Human medicine European public assessment report (EPAR): Solymbic
adalimumab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Hidradenitis Suppurativa; Psoriasis; Arthritis, Rheumatoid
Date of authorisation: 22/03/2017,, , Revision: 2, Withdrawn, Last updated: 05/03/2019
adalimumab … Solymbic adalimumab adalimumab … -
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Human medicine European public assessment report (EPAR): Trudexa
adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Arthritis, Psoriatic; Crohn Disease
Date of authorisation: 01/09/2003, Revision: 8, Withdrawn, Last updated: 14/02/2008adalimumab … STATEMENT ON Trudexa (adalimumab) WITHDRAWAL OF THE … containing the active substance adalimumab. It is available as a solution … -
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Opinion/decision on a Paediatric investigation plan (PIP): Humira, adalimumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000366-PIP02-09-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/05/2019, Last updated: 16/09/2021, Compliance check: V, 30/04/2020name Humira Active substance adalimumab Therapeutic area Gastroentology-Hepatology … Humira Humira adalimumab adalimumab adalimumab … -
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Opinion/decision on a Paediatric investigation plan (PIP): Humira, adalimumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000366-PIP05-12-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 22/07/2016, Last updated: 21/12/2016, Compliance check: V, 14/10/2016name Humira Active substance adalimumab Therapeutic area Gastroentology-Hepatology … paediatric investigation plan for adalimumab (Humira) (EMEA-000366-PIP05-12-M02 … paediatric investigation plan for adalimumab (Humira) (EMEA-000366-PIP05-12-M02 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Humira, adalimumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000366-PIP01-08-M06, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 19/12/2013, Last updated: 04/02/2014, Compliance check: V, 20/06/2014name Humira Active substance adalimumab Therapeutic area Gastroentology-Hepatology … paediatric investigation plan for adalimumab (Humira) (EMEA-000366-PIP01-08-M06 … paediatric investigation plan for adalimumab (Humira) (EMEA-000366-PIP01-08-M06 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Humira, adalimumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: EMEA-000366-PIP04-12, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 03/05/2013, Last updated: 21/06/2013, Compliance check: V, 01/04/2016name Humira Active substance adalimumab Therapeutic area Dermatology … granting of a waiver for adalimumab (Humira), (EMEA-000366-PIP04-12 … granting of a waiver for adalimumab (Humira), (EMEA-000366-PIP04-12 … -
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Withdrawn application: Fyzoclad
adalimumab, date of withdrawal: 05/12/2018, Initial authorisation, Last updated: 14/12/2018Fyzoclad Fyzoclad adalimumab adalimumab … -
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Opinion/decision on a Paediatric investigation plan (PIP): 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)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002927-PIP01-20, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection (in pre-filled syringe)
Decision date: 29/10/2010, Last updated: 14/02/2023, Compliance check: XActive 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 … -
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Opinion/decision on a Paediatric investigation plan (PIP): 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
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002927-PIP02-21, Route(s) of administration: All routes of administration, Pharmaceutical form(s): All pharmaceutical forms
Decision date: 15/04/2022, Last updated: 17/04/2023, Compliance check: XActive 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 … -
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Human medicine European public assessment report (EPAR): Bimzelx
bimekizumab, Psoriasis
Date of authorisation: 20/08/2021,, Revision: 2, Authorised, Last updated: 05/12/2022
psoriasis (ustekinumab or adalimumab). In the three studies involving … and 47% of those receiving adalimumab (in one of the studies … 57% of patients receiving adalimumab. What are the risks associated … -
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Human medicine European public assessment report (EPAR): Skyrizi
Risankizumab, Psoriasis; Arthritis, Psoriatic
Date of authorisation: 26/04/2019,, Revision: 15, Authorised, Last updated: 04/04/2023
with 47% of those receiving adalimumab. In addition, 84% of patients … with 60% of those receiving adalimumab. Finally, in the fourth study … with 47% of those receiving adalimumab. In addition, 84% of patients …