219 results
Keyword TOFACITINIB Remove keyword
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Referral: Xeljanz
tofacitinib, associated names: Xeljanz, Article 20 procedures
Status: European Commission final decision, opinion/position date: 14/11/2019, EC decision date: 31/01/2020, Last updated: 06/03/2020Xeljanz Xeljanz tofacitinib tofacitinib Tofacitinib … -
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Direct healthcare professional communication (DHPC): Xeljanz (tofacitinib): increased risk of major adverse cardiovascular events and malignancies with use of tofacitinib relative to TNF-alpha inhibitors
Active substance: tofacitinib citrate, DHPC type: Safety signal, Last updated: 06/07/2021Xeljanz (tofacitinib): increased risk of major … malignancies with use of tofacitinib relative to TNF-alpha inhibitors Arthritis … Xeljanz (tofacitinib): increased risk of major … -
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Direct healthcare professional communication (DHPC): Xeljanz (tofacitinib): Initial clinical trial results of increased risk of major adverse cardiovascular events and malignancies (excluding NMSC) with use of tofacitinib relative to TNF— alpha inhibitors
Active substance: tofacitinib citrate, DHPC type: Safety signal, Last updated: 24/03/2021Xeljanz (tofacitinib): Initial clinical trial … excluding NMSC) with use of tofacitinib relative to TNF— alpha … Xeljanz (tofacitinib): Initial clinical trial … -
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Human medicine European public assessment report (EPAR): Xeljanz
Tofacitinib, Arthritis, Rheumatoid
Date of authorisation: 22/03/2017,
Date of refusal: 25/04/2013,
, Revision: 26, Authorised, Last updated: 30/03/2023
Authorised patient safety tofacitinib Overview Xeljanz is a medicine … medicine. active substance tofacitinib. How is Xeljanz used? Xeljanz … active substance in Xeljanz, tofacitinib, works by blocking the action … -
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Human medicine European public assessment report (EPAR): Xeljanz
Tofacitinib, Arthritis, Rheumatoid Refused, Last updated: 23/07/2018tofacitinib … authorisation for Xeljanz (tofacitinib) Outcome of re-examination … contains the active substance tofacitinib. It was to be available as … -
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Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz, Tofacitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000576-PIP03-12-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral solution, Prolonged-release film-coated tablet, Prolonged-release age-appropriate oral formulation
Decision date: 15/01/2021, Last updated: 29/09/2021, Compliance check: XXeljanz Active substance Tofacitinib Therapeutic area Gastroentology-Hepatology … paediatric investigation plan Tofacitinib for treatment of ulcerative … paediatric investigation plan Tofacitinib for treatment of ulcerative … -
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Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz, Tofacitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000576-PIP01-09-M12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Prolonged-release film-coated tablet, Oral solution, Prolonged-release age-appropriate oral formulation
Decision date: 17/06/2020, Last updated: 17/03/2021, Compliance check: XXeljanz Active substance Tofacitinib Therapeutic area Immunology-Rheumatology-Transplantation … paediatric investigation plan for tofacitinib (Xeljanz), (EMEA-000576-PIP01-09-M12 … paediatric investigation plan for tofacitinib (Xeljanz), (EMEA-000576-PIP01-09-M12 … -
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Referral: Janus kinase inhibitors (JAKi) (updated)
tofacitinib, abrocitinib, baricitinib, upadacitinib, filgotinib, associated names: Xeljanz, Cibinqo, Olumiant, Rinvoq, Jyseleca, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/01/2023, EC decision date: 10/03/2023, Last updated: 22/05/2023the JAK inhibitor Xeljanz (tofacitinib) and preliminary findings … Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis … the JAK inhibitor Xeljanz (tofacitinib) in patients with rheumatoid … -
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Direct healthcare professional communication (DHPC): Updated recommendations to minimise the risks of malignancy, major adverse cardiovascular events, serious infections, venous thromboembolism and mortality with use of Janus kinase inhibitors (JAKi)
Active substance: Abrocitinib, filgotinib, Baricitinib, upadacitinib, Tofacitinib, DHPC type: Referral - Article 20 procedure, Last updated: 30/03/2023Baricitinib upadacitinib Tofacitinib Therapeutic area (MeSH) Arthritis … upadacitinib) and Xeljanz (tofacitinib) – Updated recommendations … upadacitinib) and Xeljanz (tofacitinib) are approved for the treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tofacitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-000576-PIP02-11-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral solution
Decision date: 17/03/2017, Last updated: 20/04/2017, Compliance check: XKey facts Tofacitinib DermatologyP/0055/2017EMEA-000576-PIP02-11-M04 … paediatric investigation plan for tofacitinib (EMEA- 000576-PIP02-11-M04 … paediatric investigation plan for tofacitinib (EMEA- 000576-PIP02-11-M04 … -
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Press release: Increased risk of blood clots in lungs and death with higher dose of Xeljanz (tofacitinib) for rheumatoid arthritis
CHMP, Last updated: 20/03/2019with higher dose of Xeljanz (tofacitinib) for rheumatoid arthritis … recommended dose of Xeljanz (tofacitinib) when treating rheumatoid … -
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Press release: EMA confirms Xeljanz to be used with caution in patients at high risk of blood clots
CHMP, Last updated: 15/11/2019has concluded that Xeljanz (tofacitinib) could increase the risk … -
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Press release: Restrictions in use of Xeljanz while EMA reviews risk of blood clots in lungs
PRAC, Last updated: 17/05/2019twice daily dose of Xeljanz (tofacitinib) in patients who are at high … observed in a study with tofacitinib 10 mg twice daily in rheumatoid … evaluating the safety of tofacitinib 5 mg twice daily and … -
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News: EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
CHMP, Last updated: 13/01/2023the JAK inhibitor Xeljanz (tofacitinib) and preliminary findings … the JAK inhibitor Xeljanz (tofacitinib) in patients with rheumatoid … -
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News: EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
PRAC, Last updated: 03/11/2022the JAK inhibitor Xeljanz (tofacitinib) and preliminary findings … -
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National expert: Nicolino Ruperto, European Medicines Agency (updated)
- Declaration of interests - 44.32 KB | PDF
- Curriculum Vitae - 36.31 KB | PDF
activity Current 01-06- 2016 22-03- 2023 PFIZER Individual product related TOFACITINIB Polyarthritis, Extended OligoArthritis, null Current 01-01- 2017 22-03- 2023 PFIZER Individual … OligoArthritis, null Current 01-01- 2017 22-03- 2023 PFIZER Individual product related TOFACITINIB Systemic Juvenile Idiopathic … -
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National expert: Pia Isomäki, European Medicines Agency (updated)
- Declaration of interests - 42.53 KB | PDF
- Curriculum Vitae - 34.93 KB | PDF
vasculitis null Past 01-02- 2015 01-11- 2019 Pfizer Individual product related tofacitinib (Xeljanz) rheumatoid arthritis … 039;TofaSTAT', studying the effects of tofacitinib on JAK_STAT signal transduction … -
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National expert: Javier Gisbert, European Medicines Agency (updated)
- Declaration of interests - 41.46 KB | PDF
- Curriculum Vitae - 35.61 KB | PDF
JP Gisbert.(40/40). 2021. Tofacitinib in ulcerative colitis: real … Ustekinumab) and Small Molecules (Tofacitinib) During Pregnancy: A Review.Drugs … -
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National expert: Jeanine Roeters van Lennep, European Medicines Agency (updated)
- Declaration of interests - 41.44 KB | PDF
- Curriculum Vitae - 48.85 KB | PDF
Ulcerative Colitis Receiving Tofacitinib_Implications for Cardiovascular Risk and … -
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News: EMA starts safety review of Janus kinase inhibitors for inflammatory disorders
PRAC, Last updated: 11/02/2022the JAK inhibitor Xeljanz (tofacitinib). The results showed that … -
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National expert: Christophe Richez, European Medicines Agency (updated)
- Declaration of interests - 60.86 KB | PDF
- Curriculum Vitae - 29.16 KB | PDF
product related) null null Tofacitinib et ORAL surveillance Past 01-06- 2020 01-12- 2020 MSD Cross … spondyloarthritis null Past 01-01- 2021 01-05- 2021 PFIZER Individual product related Tofacitinib rheumatoid arthritis null Past 01-09- 2019 01-09- 2019 ONO … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2019 (updated)
CHMP, Last updated: 15/11/2019CHMP concluded that Xeljanz (tofacitinib) could increase the risk … -
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National expert: Eva Baecklund, European Medicines Agency (updated)
- Declaration of interests - 41.09 KB | PDF
- Curriculum Vitae - 54.35 KB | PDF
activity Current 01-05- 2021 22-03- 2023 Pfizer Individual product related tofacitinib I have been asked by Pfizer … -
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National expert: Jérôme Avouac, European Medicines Agency (updated)
- Declaration of interests - 44.42 KB | PDF
- Curriculum Vitae - 25.53 KB | PDF
activity Current 01-01- 2018 22-03- 2023 Pfizer Individual product related Tofacitinib _ Xeljanz Rheumatoid arthritis null Past 01-01- 2018 01-01- 2022 SANOFI Individual … -
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Human medicine European public assessment report (EPAR): Jyseleca (updated)
filgotinib maleate, Arthritis, Rheumatoid
Date of authorisation: 24/09/2020,, 
, Revision: 9, Authorised, Last updated: 30/05/2023