1682 results
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Human medicine European public assessment report (EPAR): Nodetrip (previously Xeristar)
duloxetine, Anxiety Disorders; Depressive Disorder, Major; Diabetic Neuropathies
Date of authorisation: 17/12/2004, Revision: 32, Withdrawn, Last updated: 22/06/2021Nodetrip (previously Xeristar) Anxiety Disorders Depressive … documents Nodetrip (previously Xeristar) : Medicine overview PDF icon … details >Nodetrip (previously Xeristar)EMEA/H/C/000573duloxetineduloxetineAnxiety DisordersDepressive Disorder … -
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Withdrawn application: Xegafri
date of withdrawal: 05/05/2016, Initial authorisation, Last updated: 22/06/2016Xegafri: Withdrawn application … authorisation application for Xegafri (rociletinib) On 3 May … marketing authorisation for Xegafri, for the treatment of non-small … -
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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 Xeljanz tofacitinib tofacitinib To … -
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Orphan designation: Sirolimus for: Treatment of chronic non-infectious uveitis
Date of designation: 30/08/2011, Withdrawn, Last updated: 30/08/2022orphan medicinal products Xegafri: Withdrawn application Topics: … Xegafri Xegafri Sirolimus … -
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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 … Xeljanz (tofacitinib): increased … Xeljanz (tofacitinib): increased … -
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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 … Xeljanz (tofacitinib): Initial clinical … Page 1/4 DHPC Xeljanz (tofacitinib): Initial clinical … -
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Opinion/decision on a Paediatric investigation plan (PIP): Xevudy, Sotrovimab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002899-PIP01-20-M01, Route(s) of administration: Intravenous use, Intramuscular use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection/infusion
Decision date: 12/11/2021, Last updated: 13/02/2023, Compliance check: XKey facts Xevudy Sotrovimab Infectious diseasesP/0468/2021EMEA-002899-PIP01-20-M01 … 13/02/2023 EMA/627431/2021 Generic Xevudy: EPAR Topics: COVID-19 Paedi … Xevudy Xevudy sotrovimab Sotrovimab Sotr … -
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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: XInvented name Xeljanz Active substance Tofacitinib … Xeljanz Xeljanz tofacitinib Tofacitinib To … -
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Opinion/decision on a Paediatric investigation plan (PIP): Xerava, eravacycline
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001555-PIP01-13-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 15/07/2020, Last updated: 01/07/2021, Compliance check: XInvented name Xerava Active substance eravacycline … Xerava Xerava eravacycline eravacycline … -
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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: XInvented name Xeljanz Active substance Tofacitinib … investigation plan for tofacitinib (Xeljanz), (EMEA-000576-PIP01-09-M12 … investigation plan for tofacitinib (Xeljanz), (EMEA-000576-PIP01-09-M12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ariclaim, duloxetine hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Uro-nephrology
PIP number: EMEA-000420-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Gastro-resistant capsule
Decision date: 17/11/2010, Last updated: 22/06/2021, Compliance check: XYentreve Nodetrip (previously Xeristar) Cymbalta Xeristar duloxetine hydrochloride … EPAR Nodetrip (previously Xeristar): EPAR Yentreve: EPAR Topics: … ntreve Nodetrip (previously Xeristar) Cymbalta Ariclaim Yentreve Nodetrip … -
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Opinion/decision on a Paediatric investigation plan (PIP): Xelevia, sitagliptin phosphate monohydrate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000471-PIP01-08-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 21/05/2016, Last updated: 22/07/2016, Compliance check: XInvented name Xelevia Active substance sitagliptin … phosphate monohydrate) (Xelevia) (EMEA-000471-PIP01-08-M02 … phosphate monohydrate) (Xelevia) (EMEA-000471-PIP01-08-M02 … -
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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: 22/03/20231 of the JAK inhibitor Xeljanz (tofacitinib) and preliminary … representatives. The review confirmed Xeljanz increases the risk of major … trial1 of the JAK inhibitor Xeljanz (tofacitinib) and preliminary … -
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Human medicine European public assessment report (EPAR): Xelevia
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2007, Revision: 37, Authorised, Last updated: 31/01/2023Xelevia Nutritional and Metabolic … Xelevia … summary for the public Xelevia sitagliptin This is a … -
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Human medicine European public assessment report (EPAR): Xevudy
Sotrovimab, COVID-19 virus infection
Date of authorisation: 17/12/2021,
, Revision: 7, Authorised, Last updated: 12/01/2023
Xevudy Pneumonia, Viral Pneumonia Respiratory … thorised sotrovimab Overview Xevudy is a medicine used for treating … EMA/720729/2021 EMEA/H/C/005676 Xevudy (sotrovimab) An overview of Xevudy and why it is authorised … -
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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: 04/10/2022
Xeljanz Musculoskeletal Diseases Joint … Xeljanz … EMA/726358/2021 EMEA/H/C/004214 Xeljanz (tofacitinib) An overview … -
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Human medicine European public assessment report (EPAR): Xeloda
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 02/02/2001, Revision: 30, Authorised, Last updated: 26/10/2022Xeloda Cancer Neoplasms Colorectal … Xeloda … alfa-2a), Tamiflu (oseltamivir), Xeloda (capecitabine) and Xenical (orlistat), which contain … -
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Orphan designation: Recombinant human acid sphingomyelinase (also known as olipudase alfa) for: Treatment of Niemann-Pick disease
Date of designation: 24/06/2022, Positive, Last updated: 27/07/2022been authorised in the EU as Xenpozyme since 24 June 2022. Expand … Xenpozyme Xenpozyme olipudase alfa Recombinant … the orphan designation of Xenpozyme at the time of marketing … -
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Human medicine European public assessment report (EPAR): Xerava
eravacycline, Infection; Bacterial Infections
Date of authorisation: 20/09/2018,, Revision: 4, Authorised, Last updated: 19/08/2021
Xerava Infections Bacterial Infections … Xerava … initial authorisation) Xerava eravacycline On 26 July … -
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Human medicine European public assessment report (EPAR): Xeplion
paliperidone palmitate, Schizophrenia
Date of authorisation: 04/03/2011, Revision: 14, Authorised, Last updated: 27/05/2021Xeplion Mental Disorders Schizophre … Xeplion … Xeplion, INN-paliperidone palmitate … -
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Human medicine European public assessment report (EPAR): Xenleta
lefamulin acetate, Pneumonia, Bacterial; Community-Acquired Infections
Date of authorisation: 27/07/2020,, Revision: 1, Authorised, Last updated: 08/07/2021
Xenleta Infections Bacterial Infections … Xenleta … THE MEDICINAL PRODUCT Xenleta 600 mg film-coated tablets … -
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Human medicine European public assessment report (EPAR): Xeljanz
Tofacitinib, Arthritis, Rheumatoid Refused, Last updated: 23/07/2018Xeljanz Arthritis, Rheumatoid … Xeljanz … marketing authorisation for Xeljanz (tofacitinib) Outcome of … -
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Human medicine European public assessment report (EPAR): Xenical
orlistat, Obesity
Date of authorisation: 29/07/1998, Revision: 24, Authorised, Last updated: 07/05/2020Xenical Overweight Body Weight Body … Xenical … alfa-2a), Tamiflu (oseltamivir), Xeloda (capecitabine) and Xenical (orlistat), which contain … -
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Human medicine European public assessment report (EPAR): Xermelo
telotristat etiprate, Carcinoid Tumor; Neuroendocrine Tumors
Date of authorisation: 17/09/2017,
, Revision: 15, Authorised, Last updated: 12/12/2022
Xermelo Neoplasms, Germ Cell and … assessment report (EPAR) for Xermelo. It explains how the Agency … practical advice on how to use Xermelo. For practical information … -
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Human medicine European public assessment report (EPAR): Xenpozyme
Olipudase alfa, Acid sphingomyelinase deficiency (ASMD) type A/B or type B
Date of authorisation: 24/06/2022,, , Authorised, Last updated: 27/07/2022
Xenpozyme Niemann-Pick Diseases Sphingolipidoses Lysosomal … Xenpozyme … EMA/329151/2022 EMEA/H/C/004850 Xenpozyme (olipudase alfa) An overview …