1185 results
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Referral: Avalox
moxifloxacin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/06/2009, EC decision date: 02/10/2009, Last updated: 19/11/2013Avalox … authorisation of the medicine Avalox solution for infusion. The … concluded that the benefits of Avalox solution for infusion outweigh … -
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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): 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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Opinion/decision on a Paediatric investigation plan (PIP): Moxifloxacin hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000288-PIP01-08-M02, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Solution for infusion, Granules and solvent for oral suspension
Decision date: 24/11/2010, Last updated: 21/12/2010, Compliance check: XKey facts Avalox and associated names; Octegra … moxifloxacin hydrochloride (Avalox and associated names; Octegra … moxifloxacin hydrochloride (Avalox and associated names; Octegra … -
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Referral: Moxifloxacin
moxifloxacin, associated names: Avalox, Avelox, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 24/07/2008, EC decision date: 24/10/2008, Last updated: 24/07/2008Member States as Avelox and Avalox, as well as other invented … medicineMoxifloxacinmoxifloxacin Avalox Avelox About this procedureCHMP/380454/08 … Member States as Avelox and Avalox, as well as other invented … -
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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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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,17-19 March 2008
CHMP, Last updated: 20/03/2008Actira, Avalox, Octegra and associated invented … -
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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 (updated)
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 05/10/2008, Revision: 17, Authorised, Last updated: 21/03/2023compared 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): 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: 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 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Argon, oxygen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-002921-PIP01-20, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Medicinal gas, compressed
Decision date: 07/05/2021, Last updated: 15/02/2022, Compliance check: XNeurologyP/0187/2021EMEA-002921-PIP01-20 Medicinal gas, compressed Treatment of acute ischaemic … oxygen, medicinal gas, compressed, inhalation use, the details … form(s): Medicinal gas, compressed Route(s) of administration … -
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Press release: Novartis Europharm Ltd. withdraws its application for an extension of indication for Zometa (zoledronic acid)
Last updated: 15/12/2010pathological fractures, spinal compression, radiation or surgery to bone … pathological fractures, spinal compression, radiation or surgery to … -
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Herbal medicinal product: Hippocastani semen
Aesculus hippocastanum L., Horse-Chestnut Seed, F: Assessment finalised, Last updated: 24/07/2020both with placebo and with compression stockings and led to a significant … comparable to the effect of compression stockings. The Committee … -
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Orphan designation: Soluble recombinant human fibroblast growth factor receptor 3 for: Treatment of achondroplasia (updated)
Date of designation: 27/02/2017, Withdrawn, Last updated: 24/03/2023bowed 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: New treatment for people with dwarfism
CHMP, Last updated: 25/06/2021health complications, such as compression of the spinal cord, bowed … limb length, correct spinal compression or bowed legs. Most patients … -
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Orphan designation: L-threo-3,4-dihydroxyphenylserine for: Treatment of orthostatic hypotension in patients with multiple system atrophy
Date of designation: 02/08/2007, Withdrawn, Last updated: 28/01/2022water and salt intake, using compression stockings, and by the use … water and salt intake, using compression stockings, and by the use …