1232 results
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Human medicine European public assessment report (EPAR): Keppra
levetiracetam, Epilepsy
Date of authorisation: 29/09/2000, Revision: 52, Authorised, Last updated: 10/03/2022Keppra Nervous System Diseases Central … assessment report (EPAR) for Keppra. It explains how the The committee … the conditions of use for Keppra. What is Keppra? Keppra is a medicine that contains … -
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Press release: EMA recommends measures to ensure safe use of Keppra oral solution
CHMP, Last updated: 14/10/2016measures to ensure safe use of Keppra oral solution … measures to ensure safe use of Keppra oral solution … appropriate:] 3 – How to take Keppra Always take this medicine … -
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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): Levetiracetam Actavis
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,
, Revision: 18, Authorised, Last updated: 01/07/2022
authorised in the EU called Keppra. How is Levetiracetam Actavis … with the reference medicine, Keppra, and do not need to be repeated … to the reference medicine, Keppra. Two medicines are bioequivalent … -
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Human medicine European public assessment report (EPAR): Levetiracetam ratiopharm
levetiracetam, Epilepsy
Date of authorisation: 26/08/2011,, Revision: 14, Authorised, Last updated: 10/06/2022
authorised in the EU called Keppra. How is Levetiracetam ratiopharm … with the reference medicine, Keppra, and do not need to be repeated … to the reference medicine, Keppra. Two medicines are bioequivalent … -
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Human medicine European public assessment report (EPAR): Levetiracetam Sun
levetiracetam, Epilepsy
Date of authorisation: 14/12/2011,, Revision: 17, Authorised, Last updated: 24/06/2022
authorised in the EU called Keppra. How is Levetiracetam Sun … with the reference medicine, Keppra, and do not need to be repeated … shown to be comparable to Keppra. Therefore, the Agency’s … -
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Human medicine European public assessment report (EPAR): Levetiracetam Accord
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 14, Authorised, Last updated: 13/01/2022
authorised in the EU called Keppra. How is Levetiracetam Accord … with the reference medicine, Keppra, and do not need to be repeated … and to be bioequivalent to Keppra. Therefore, the Agency’s … -
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Human medicine European public assessment report (EPAR): Levetiracetam Teva
levetiracetam, Epilepsy
Date of authorisation: 25/08/2011,, Revision: 19, Authorised, Last updated: 06/07/2022
authorised in the EU called Keppra. How is Levetiracetam Teva … with the reference medicine, Keppra, and do not need to be repeated … and to be bioequivalent to Keppra. Therefore, the Agency’s … -
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Human medicine European public assessment report (EPAR): Matever
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 26, Authorised, Last updated: 09/06/2022
European Union (EU) called Keppra. What is Matever used for … to the reference medicine, Keppra. Two medicines are bioequivalent … and to be bioequivalent to Keppra. Therefore, the Committee … -
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Human medicine European public assessment report (EPAR): Levetiracetam Actavis Group
levetiracetam, Epilepsy
Date of authorisation: 04/12/2011,, Revision: 16, Authorised, Last updated: 01/07/2022
authorised in the EU called Keppra. How is Levetiracetam Actavis … with the reference medicine, Keppra, and do not need to be repeated … and to be bioequivalent to Keppra. Therefore, the Agency’s … -
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Human medicine European public assessment report (EPAR): Levetiracetam Hospira
levetiracetam, Epilepsy
Date of authorisation: 07/01/2014,, Revision: 23, Authorised, Last updated: 15/06/2022
authorised in the EU called Keppra. Expand section Collapse section … with the reference medicine, Keppra, and do not need to be repeated … shown to be comparable to Keppra. 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 Mylan
zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012,, Revision: 13, Authorised, Last updated: 24/06/2022
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: 14, Authorised, Last updated: 05/01/2022
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): Evicel
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 05/10/2008, Revision: 16, Authorised, Last updated: 17/11/2020compared 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): VeraSeal (updated)
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): 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): Camcevi
leuprorelin mesilate, Prostatic Neoplasms
Date of authorisation: 24/05/2022, Authorised, Last updated: 20/06/2022patients 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: 23, Authorised, Last updated: 21/07/2022breaks 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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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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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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Orphan designation: Soluble recombinant human fibroblast growth factor receptor 3 for: Treatment of achondroplasia
Date of designation: 27/02/2017, Positive, Last updated: 31/03/2017bowed 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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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2016
CHMP, Last updated: 14/10/2016measures to ensure safe use of Keppra oral solution …