1650 results
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Referral: Tibolona Aristo and Tibocina and associated names
tibolone, associated names: Tibolon Aristo, Tibolinia, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/12/2013, EC decision date: 05/03/2014, Last updated: 08/04/2014Tibolona Aristo and Tibocina and associated … of the medicines Tibolona Aristo and Tibocina. The Agency's … the benefits of Tibolona Aristo and Tibocina outweigh their … -
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Press release: Wyeth Consumer Healthcare withdraws its marketing authorisation application for Ibuprofen/Diphenhydramine Hydrochloride Wyeth
Last updated: 13/01/2010authorisation application for Ibuprofen/Diphenhydramine Hydrochloride Wyeth … authorisation for the medicine Ibuprofen/Diphenhydramine Hydrochloride Wyeth 200 mg/25 … marketing authorisation for Ibuprofen/Diphenhydramine Hydrochloride Wyeth was submitted … -
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Risks associated with the use of herbal products containing Aristolochia species - Scientific guideline
Last updated: 23/11/2005herbal products containing Aristolochia species - Scientific guidelin … herbal products containing Aristolochia species - Scientific guidelin … with use of HMPs containing aristolochia species European …
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News: Position paper on the risks associated with the use of herbal products containing aristolochia species
HMPC, Last updated: 31/10/2000herbal products containing aristolochia species … herbal products containing Aristolochia species PDF icon application/pdf … herbal products containing Aristolochia Species The European … -
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Ibuprofen product-specific bioequivalence guidance
Last updated: 04/04/2022Ibuprofen product-specific bioequivalence … conditions. bioequivalence of ibuprofen. … Ibuprofen oral use immediate release …
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Press release: Updated advice on use of high-dose ibuprofen
CMDh, Last updated: 22/05/2015advice on use of high-dose ibuprofen … advice on the use of high-dose ibuprofen. This follows a review carried … patients taking high doses of ibuprofen (at or above 2,400 mg per … -
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Press release: PRAC recommends updating advice on use of high-dose ibuprofen
PRAC, Last updated: 13/04/2015advice on use of high-dose ibuprofen … advice on use of high-dose ibuprofen … advice on use of high‑dose ibuprofen 30 Churchill Place … -
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Press release: European Medicines Agency starts review of ibuprofen medicines
PRAC, Last updated: 13/06/2014Medicines Agency starts review of ibuprofen medicines … Medicines Agency starts review of ibuprofen medicines … Medicines Agency starts review of ibuprofen medicines Review to evaluate … -
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Referral: GVK Biosciences
esomeprazole magnesium, candesartan cilexetil, nebivolol, desloratadine, donepezil, repaglinide, candesartan, esomeprazole, alendronic acid, ropinirole, cefpodoxime, quetiapine, trimetazidine, bosentan, tramadol, paracetamol, escitalopram, trimetazidine hydrochloride, entacapone, valsartan, hydrochlorothiazide, donepezil hydrochloride, ropinirole hydrochloride, clopidogrel hydrochloride, escitalopram oxalate, metformin hydrochloride, trimetazidine dihydrochloride, rizatriptan benzoate, metformin, fluconazole, eletriptan, rizatriptan, ebastine, ibuprofen, desmopressin, aciclovir, levetiracetam, irbesartan, venlafaxine, ciprofloxacin, cefpodoxime proxetil, tacrolimus, fexofenadine hydrochloride, phenoxymethylpenicillin, amlodipine besilate, metoclopramide, clopidogrel, levodopa, carbidopa, entacapone, atorvastatin, telmisartan, clindamycin hydrochloride, metoclopramide hydrochloride, clonazepam, clobazam, dexamethasone, thiamine hydrochloride, tramadol hydrochloride, pioglitazone, dipyridamole, fexofenadine, amlodipine, pantoprazole, hydrocortisone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/05/2015, EC decision date: 16/07/2015, Last updated: 04/08/2015benzoate metformin fluconazole eletriptan rizatriptan ebastine ibuprofen desmopressin aciclovir levetiracetam irbesartan venlafaxine ciprofloxacin cefpodoxime … -
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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 Actavis (updated)
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 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 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 (updated)
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): Dynastat
parecoxib sodium, Pain, Postoperative
Date of authorisation: 22/03/2002, Revision: 32, Authorised, Last updated: 17/08/2022other painkillers such as ibuprofen, ketorolac, morphine, tramadol … -
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National expert: Joao Jose Sousa, National Authority Of Medicines And Health Products (updated)
- Declaration of interests - 39.39 KB | PDF
- Curriculum Vitae - 47.84 KB | PDF
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National expert: Javier Alonso Naveda, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 39.3 KB | PDF
- Curriculum Vitae - 34.11 KB | PDF
Albumin as filler for direct compressed tablets prolonged release … prolonged release of S_(+) Ibuprofen. Department of Pharmacy and … -
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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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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2014
PRAC, Last updated: 13/06/2014Review of ibuprofen medicines started … -
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Orphan designation: Soluble recombinant human fibroblast growth factor receptor 3 for: Treatment of achondroplasia
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: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2015
PRAC, Last updated: 13/04/2015advice on use of high‑dose ibuprofen …