1195 results
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Human medicine European public assessment report (EPAR): Bondronat
ibandronic acid, Hypercalcemia; Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone
Date of authorisation: 25/06/1996, Revision: 31, Authorised, Last updated: 24/03/2021Bondronat Cancer Neoplasms Nutritional … Bondronat … Bondronat, INN-ibandronic acid … -
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Human medicine European public assessment report (EPAR): Iasibon
ibandronic acid, Hypercalcemia; Fractures, Bone; Neoplasm Metastasis; Breast Neoplasms
Date of authorisation: 21/01/2011,
, Revision: 11, Authorised, Last updated: 14/11/2022
European Union (EU) called Bondronat. What is Iasibon used for … to the reference medicine, Bondronat. Two medicines are bioequivalent … and to be bioequivalent to Bondronat. Therefore, the Committee … -
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Human medicine European public assessment report (EPAR): Ibandronic Acid Sandoz
ibandronic acid, Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone
Date of authorisation: 26/07/2011,, Revision: 9, Authorised, Last updated: 06/07/2022
Ibandronic Acid Sandoz is Bondronat. What is Ibandronic Acid Sandoz … and to be bioequivalent to Bondronat. Therefore, the CHMP’s view … CHMP’s view was that, as for Bondronat, the benefit outweighs the … -
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Withdrawn application: Ibandronic Acid Hexal
ibandronic acid, date of withdrawal: 21/07/2011, Initial authorisation, Last updated: 22/08/2011the European Union called Bondronat. What was Ibandronic Acid … as the reference medicine, Bondronat. The active substance in Ibandronic … Ibandronic Acid Hexal and Bondronat, ibandronic acid, is a bisphosphonate … -
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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): Ibandronic acid Accord (updated)
ibandronic acid, Wounds and Injuries; Breast Diseases; Neoplastic Processes; Calcium Metabolism Disorders; Water-Electrolyte Imbalance
Date of authorisation: 18/11/2012,, Revision: 14, Authorised, Last updated: 05/01/2023
Ibandronic acid Accord are Bondronat and Bonviva. How is Ibandronic … the reference medicines, Bondronat and Bonviva, and do not need … shown to be comparable to Bondronat and Bonviva. Therefore, the … -
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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): Ibandronic Acid Teva
ibandronic acid, Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone; Osteoporosis, Postmenopausal
Date of authorisation: 17/09/2010,, Revision: 12, Authorised, Last updated: 22/11/2022
Ibandronic Acid Teva are Bondronat and Bonviva. What is Ibandronic … and to be bioequivalent to Bondronat and Bonviva. Therefore, the … ’s view was that, as for Bondronat and Bonviva, the benefit … -
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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 (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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Press release: European Medicines Agency concludes class review of bisphosphonates and atypical fractures
CHMP, Last updated: 15/04/2011Aclasta, Adrovance, Bondenza, Bondronat, Bonviva, Fosavance, Ibandronic … Aclasta, Adrovance, Bondenza, Bondronat, Bonviva, Fosavance, Ibandronic … -
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Press release: European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection
Last updated: 19/11/2013concerned: Avastin, Bondenza, Bondronat, Bonviva, Cellcept, Fuzeon … concerned: Avastin, Bondenza, Bondronat, Bonviva, Cellcept, Fuzeon … -
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Referral: Bisphosphonates
alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid, zoledronic acid, associated names: Actonel, Aredia, Bonefos, Didronel, Fosamax, Nerixia, Skelid, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/04/2011, EC decision date: 13/07/2011, Last updated: 28/10/2011Adrovance: EPAR Bondenza: EPAR Bondronat: EPAR Bonviva: EPAR Fosavance … acid), Bondenza, Bonviva, Bondronat and Ibandronic acid Teva … Aclasta, Adrovance, Bondenza, Bondronat, Bonviva, Fosavance, Ibandronic … -
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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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Press release: European Medicines Agency starts infringement procedure to investigate Roche's alleged non-compliance with pharmacovigilance obligations
Last updated: 23/10/2012Ibandronic Acid Roche): EPAR Bondronat: EPAR Bonviva: EPAR CellCept … medicines: Avastin, Bondenza, Bondronat, Bonviva, Cellcept, Fuzeon … -
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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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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 …