211 results
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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, 30/04/2020Invented name Humira Active substance adalimumab … Humira Humira adalimumab adalimumab adal … -
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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, 14/10/2016Invented name Humira Active substance adalimumab … investigation plan for adalimumab (Humira) (EMEA-000366-PIP05-12-M02 … 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, 20/06/2014Invented name Humira Active substance adalimumab … investigation plan for adalimumab (Humira) (EMEA-000366-PIP01-08-M06 … 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, 01/04/2016Invented name Humira Active substance adalimumab … a waiver for adalimumab (Humira), (EMEA-000366-PIP04-12 … a waiver for adalimumab (Humira), (EMEA-000366-PIP04-12 … -
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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: 16/12/2022Humira Musculoskeletal Diseases Bone … thorised adalimumab Overview Humira is a medicine that acts on … the white of the eyeball). Humira is mostly used in adults … -
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Orphan designation: Refusal of orphan designation for the treatment of cystic fibrosis
Date of refusal of designation: 16/07/2010, Negative, Last updated: 09/08/2010Telefax: +45 43 58 37 69 E-mail: fiala@serendex.com … 45 43 58 37 69 E-mail: fiala@serendex.com Patient associations’ … -
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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,
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, Revision: 13, Authorised, Last updated: 05/12/2022
reference medicine for Hulio is Humira. Expand section Collapse section … with the reference medicine Humira have shown that the active … highly similar to that in Humira in terms of structure, purity … -
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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
reference medicine for Idacio is Humira. Expand section Collapse section … with the reference medicine Humira have shown that the active … highly similar to that in Humira in terms of structure, purity … -
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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
reference medicine for Imraldi is Humira. How is Imraldi used? Imraldi … studies comparing Imraldi with Humira have shown that the active … highly similar to that in Humira in terms of structure, purity … -
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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
medicine for Amsparity is Humira. Expand section Collapse section … with the reference medicine Humira have shown that the active … highly similar to that in Humira in terms of structure, purity … -
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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
reference medicine for Hefiya is Humira. How is Hefiya used? Hefiya … studies comparing Hefiya with Humira have shown that the The substance … highly similar to that in Humira in terms of structure, purity … -
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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
reference medicine for Hyrimoz is Humira. For more information on A … studies comparing Hyrimoz with Humira have shown that the The substance … highly similar to that in Humira in terms of structure, purity … -
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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
reference medicine for Yuflyma is Humira. For more information on A … studies comparing Yuflyma with Humira have shown that the The substance … highly similar to that in Humira in terms of structure, purity … -
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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
medicine for Hukyndra is Humira. For more information on A … studies comparing Hukyndra with Humira have shown that the The substance … highly similar to that in Humira in terms of structure, purity … -
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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
medicine for Amgevita is Humira. How is Amgevita used? Amgevita … studies comparing Amgevita with Humira have shown that adalimumab … similar to adalimumab in Humira in terms of chemical structure … -
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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
medicine for Libmyris is Humira. For more information on A … studies comparing Libmyris with Humira have shown that the The substance … highly similar to that in Humira in terms of structure, purity … -
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Press release: First medicine recommended for approval for hidradenitis suppurativa
CHMP, Last updated: 26/06/2015condition to be added to Humira's approved uses … condition to be added to Humira’s approved uses The European … recommended extending the use of Humira (adalimumab) to include … -
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National expert: Christine Vaculik, Austrian Agency for Health and Food Safety (updated)
- Declaration of interests - 39.34 KB | PDF
- Curriculum Vitae - 28.62 KB | PDF
Schuster C, Vaculik C., Prior M, Fiala C, Mildner M, Eppel W, Stingl … Schuster C., Vaculik C., Fiala C., Meindl S., Brandt O … -
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National expert: Ralf Reinhard Tönjes, Paul-Ehrlich-Institut (updated)
- Declaration of interests - 41.48 KB | PDF
- Curriculum Vitae - 199.06 KB | PDF
Authorised medicinal products: Humira, Synagis, Rituximab; Compassionate … Authorised medicinal products: Humira, Synagis, Rituximab; Compassionate … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2014
CHMP, Last updated: 25/07/2014Humira … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2016
CHMP, Last updated: 11/11/2016Arzerra, Caprelsa, Humira, Nimenrix … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 February 2015
CHMP, Last updated: 27/02/2015Humira … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 February 2012
CHMP, Last updated: 17/02/2012PDF icon application/pdf Humira adalimumab Abbott Laboratories … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 July 2012
CHMP, Last updated: 20/07/2012Humira International non-proprietary … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2015
CHMP, Last updated: 26/06/2015Humira …