1355 results
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Opinion/decision on a Paediatric investigation plan (PIP): Xarelto, rivaroxaban
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000430-PIP01-08-M11, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Film-coated tablet
Decision date: 17/04/2019, Last updated: 21/09/2021, Compliance check: V, 20/09/2019Invented name Xarelto Active substance rivaroxaban … Xarelto Xarelto rivaroxaban rivaroxaban ri … -
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Human medicine European public assessment report (EPAR): Xarelto
rivaroxaban, Arthroplasty, Replacement; Venous Thromboembolism
Date of authorisation: 30/09/2008, Revision: 40, Authorised, Last updated: 02/08/2023Xarelto Surgical Procedures, Operative Orthopedic … horised rivaroxaban Overview Xarelto is an anticoagulant medicine … It is used with aspirin. Xarelto contains the The substance … -
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News: EMA concludes defective device in ROCKET study does not impact Xarelto's safety
Last updated: 05/02/2016ROCKET study does not impact Xarelto's safety … main trial supporting use of Xarelto in atrial fibrillation … -
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Human medicine European public assessment report (EPAR): Rivaroxaban Accord
rivaroxaban, Acute Coronary Syndrome; Coronary Artery Disease; Peripheral Arterial Disease; Venous Thromboembolism; Stroke; Atrial Fibrillation; Pulmonary Embolism
Date of authorisation: 16/11/2020,
, Revision: 5, Authorised, Last updated: 12/10/2023
authorised in the EU called Xarelto. Expand section Collapse section … with the reference medicine, Xarelto, and do not need to be repeated … and to be bioequivalent to Xarelto. Therefore, the Agency’s … -
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Human medicine European public assessment report (EPAR): Zometa
zoledronic acid, zoledronic acid monohydrate, Cancer; Fractures, Bone
Date of authorisation: 20/03/2001, Revision: 36, Authorised, Last updated: 09/07/2021breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … any fractures or any spinal compression. Zometa has also been compared … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Rivaroxaban Viatris (previously Rivaroxaban Mylan)
rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
Date of authorisation: 12/11/2021,, Revision: 4, Authorised, Last updated: 23/06/2023
authorised in the EU called Xarelto. For more information on A … with the reference medicine, Xarelto, and do not need to be repeated … and to be bioequivalent to Xarelto. Therefore, the Agency’s … -
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Human medicine European public assessment report (EPAR): Zoledronic Acid Accord
zoledronic acid monohydrate, Hypercalcemia; Fractures, Bone; Cancer
Date of authorisation: 16/01/2014,, Revision: 9, Authorised, Last updated: 24/01/2022
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zoledronic acid medac
zoledronic acid monohydrate, Fractures, Bone; Cancer
Date of authorisation: 03/08/2012,, Revision: 13, Authorised, Last updated: 20/11/2020
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Actavis
zoledronic acid monohydrate, Fractures, Bone
Date of authorisation: 20/04/2012,, Revision: 15, Authorised, Last updated: 01/06/2023
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … pathological fractures, spinal compression, radiation or surgery to … -
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Human medicine European public assessment report (EPAR): Zoledronic Acid Hospira
zoledronic acid monohydrate, Hypercalcemia
Date of authorisation: 19/11/2012,, Revision: 18, Authorised, Last updated: 09/11/2021
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Mylan
zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012,, Revision: 14, Authorised, Last updated: 20/04/2023
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva
zoledronic acid, Fractures, Bone; Cancer
Date of authorisation: 16/08/2012,, Revision: 14, Authorised, Last updated: 11/10/2021
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … pathological fractures, spinal compression, radiation or surgery to … -
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Human medicine European public assessment report (EPAR): VeraSeal
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 10/11/2017, Revision: 7, Authorised, Last updated: 12/01/2023worked better than manual compression, with 76% of patients having … compared with 23% after manual compression (13 out of 57). In a second … intermittent application of compresses, swabs, use of suction devices … -
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Human medicine European public assessment report (EPAR): Evicel
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 05/10/2008, Revision: 18, Authorised, Last updated: 11/05/2023compared Evicel with manual compression (applying direct pressure … received Evicel or manual compression. The second study compared … patients treated with manual compression (28 out of 72). During abdominal … -
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Human medicine European public assessment report (EPAR): IntronA
interferon alfa-2b, Carcinoid Tumor; Leukemia, Hairy Cell; Lymphoma, Follicular; Hepatitis B, Chronic; Hepatitis C, Chronic; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Melanoma; Multiple Myeloma
Date of authorisation: 09/03/2000, Revision: 34, Withdrawn, Last updated: 15/12/2022major organ obstruction or compression syndrome, orbital or epidural … -
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Human medicine European public assessment report (EPAR): Camcevi
leuprorelin mesilate, Prostatic Neoplasms
Date of authorisation: 24/05/2022, Revision: 1, Authorised, Last updated: 12/05/2023patients with spinal cord compression or those whose cancer has … patients with spinal cord compression or those whose cancer has … -
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Human medicine European public assessment report (EPAR): Xgeva
denosumab, Fractures, Bone; Neoplasm Metastasis
Date of authorisation: 13/07/2011, Revision: 24, Authorised, Last updated: 17/07/2023breaks in the bone), spinal compression (pressure on the spinal cord … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), or complications … -
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Press release: No change is needed in use of direct oral anticoagulants following EMA-funded study
CHMP, Last updated: 27/03/2020dabigatran etexilate) and Xarelto (rivaroxaban) is needed following … taking Eliquis, Pradaxa and Xarelto was similar to that seen … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2013
CHMP, Last updated: 22/03/2013Xarelto INN rivaroxaban Marketing-authorisation … of a disease. indication Xarelto 2.5 mg Xarelto, co-administered with acetylsalicylic … application/pdf Summary of opinion for Xarelto … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 September 2011
CHMP, Last updated: 23/09/2011PDF icon application/pdf Xarelto rivaroxaban Bayer Schering … -
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Orphan designation: Modified recombinant human C-type natriuretic peptide (Vosoritide) for: Treatment of achondroplasia
Date of designation: 24/01/2013, Positive, Last updated: 09/09/2021bowed legs, ear problems, compression of the spinal cord, as well … length, to correct spinal compression or to correct bowed legs … bowed legs, ear problems, compression of the spinal cord, as well … -
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National expert: Johanna Kuusisto, European Medicines Agency (updated)
- Declaration of interests - 45 KB | PDF
- Curriculum Vitae - 25.93 KB | PDF
null Past 01- 01- 2019 01- 12- 2021 Bayer Individual product related Xarelto/rivaroxaban Chronic coronary syndromes … Agency 2023-06-19 Past 01- 01- 2019 01- 01- 2021 Bayer Individual product related Xarelto/rivaroxaban Chronic coronary syndromes … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2012
CHMP, Last updated: 19/10/2012Xarelto … -
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Orphan designation: C-type natriuretic peptide conjugated to multi-arm polyethylene glycol carrier through a cleavable linker for: Treatment of achondroplasia
Date of designation: 27/07/2020, Positive, Last updated: 19/11/2020bowed legs, ear problems, compression of the spinal cord, as well … -
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Press release: Novartis withdraws its application to extend the marketing authorisation for Zometa
CHMP, Last updated: 20/11/2007pathological fractures, spinal compression, radiation or surgery to bone … pathological fractures, spinal compression, radiation or surgery to …