119 results
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Human medicine European public assessment report (EPAR): Omidria
ketorolac, phenylephrine, Lens Implantation, Intraocular; Pain, Postoperative
Date of authorisation: 28/07/2015, Revision: 6, Authorised, Last updated: 13/08/2020phenylephrine / ketorolac … Omidria phenylephrine / ketorolac This is a summary of the … substances phenylephrine and ketorolac. How is Omidria used? Omidria … -
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Opinion/decision on a Paediatric investigation plan (PIP): phenylephrine hydrochloride, ketorolac trometamol (OMS302)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-001256-PIP02-12-M02, Route(s) of administration: Intraocular use, Ocular use, Pharmaceutical form(s): Concentrate for solution for injection, Irrigation solution
Decision date: 07/12/2018, Last updated: 19/02/2019, Compliance check: Xphenylephrine hydrochloride ketorolac trometamol (OMS302) Therapeutic … phenylephrine hydrochloride ketorolac trometamol (OMS302 … -
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Questions and Answers on ketoprofen, ketorolac and piroxicam
Last updated: 31/12/2009and Answers on ketoprofen, ketorolac and piroxicam …
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Press release: EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision; Aurobindo Pharma stopped from supplying irbesartan to the EU
Last updated: 15/10/2018under increased supervision; Aurobindo Pharma stopped from supplying … Aurobindo Pharma stopped from supplying … -
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Human medicine European public assessment report (EPAR): Nevanac
nepafenac, Pain, Postoperative; Ophthalmologic Surgical Procedures
Date of authorisation: 11/12/2007, Revision: 17, Authorised, Last updated: 16/11/2021either with placebo, with ketorolac eye drops (another NSAID … or with both placebo and ketorolac. The main measure of effectiveness … placebo and as effective as ketorolac in reducing signs of inflammation … -
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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: 17/08/2022painkillers such as ibuprofen, ketorolac, morphine, tramadol and valdecoxib … -
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Press release: European Medicines Agency update on review of non-selective NSAIDs
Last updated: 26/09/2006further examined: ketoprofen, ketorolac and piroxicam. While the … respect to ketoprofen and ketorolac, the CHMP has concluded that … further examined: ketoprofen, ketorolac and piroxicam. While the … -
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Referral: Didanosine
didanosine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/09/2013, EC decision date: 20/11/2013, Last updated: 10/12/2013was Didanosine reviewed? Aurobindo Pharma (Malta) Limited submitted … was Didanosine reviewed? Aurobindo Pharma (Malta) Limited submitted … administration France Aurobindo Pharma (Malta) Limited … -
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Press release: European Medicines Agency finalises review of recent published data on cardiovascular safety of NSAIDs
CHMP, Last updated: 19/10/2012indomethacin, ketoprofen, ketorolac, meloxicam, nabumetone, naproxen … indomethacin, ketoprofen, ketorolac, meloxicam, nabumetone, naproxen … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2015
CHMP, Last updated: 22/05/2015phenylephrine / ketorolac) received a positive opinion … -
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National expert: Roberto Villa, Ministry for Health (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 22.06 KB | PDF
perioperative efficacy of intravenous ketorolac in dogs. Journal of Veterinary Pharmacology … perioperative efficacy of intravenous ketorolac in horse. Journal of Equine Veterinary … -
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National expert: Maria Formosa Cassar, Medicines Authority (updated)
- Declaration of interests - 80.36 KB | PDF
- Curriculum Vitae - 22.17 KB | PDF
Authorisations (pertaining to MAH: Aurobindo Pharma Malta) and PV documentation. Analytical … -
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Press release: European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection
Last updated: 19/11/2013interferon alfa-2a, isotretinoin, ketorolac tromethamine, lactulose … interferon alfa-2a, isotretinoin, ketorolac tromethamine, lactulose … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2013
CHMP, Last updated: 20/09/2013Marketing-authorisation holder Aurobindo Pharma (Malta) Limited More … -
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Human medicine European public assessment report (EPAR): Opatanol
olopatadine hydrochloride, Conjunctivitis, Allergic
Date of authorisation: 16/05/2002, Revision: 23, Authorised, Last updated: 24/08/2022 -
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Human medicine European public assessment report (EPAR): Efient (updated)
prasugrel, Acute Coronary Syndrome; Angina, Unstable; Myocardial Infarction
Date of authorisation: 24/02/2009, Revision: 24, Authorised, Last updated: 21/11/2022 -
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Human medicine European public assessment report (EPAR): Exparel liposomal (updated)
bupivacaine, Acute Pain
Date of authorisation: 16/11/2020, Revision: 1, Authorised, Last updated: 14/11/2022 -
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Human medicine European public assessment report (EPAR): Inhixa
enoxaparin sodium, Venous Thromboembolism
Date of authorisation: 15/09/2016,
, Revision: 22, Authorised, Last updated: 06/09/2022
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Human medicine European public assessment report (EPAR): Emadine
emedastine difumarate, Conjunctivitis, Allergic
Date of authorisation: 27/01/1999, Revision: 25, Authorised, Last updated: 06/04/2022 -
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Human medicine European public assessment report (EPAR): Glidipion (previously Pioglitazone Actavis Group)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/03/2012,
, Revision: 8, Withdrawn, Last updated: 17/10/2022
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Human medicine European public assessment report (EPAR): Dexdor
dexmedetomidine hydrochloride, Conscious Sedation
Date of authorisation: 15/09/2011, Revision: 15, Authorised, Last updated: 14/07/2022 -
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Human medicine European public assessment report (EPAR): Faslodex
fulvestrant, Breast Neoplasms
Date of authorisation: 09/03/2004, Revision: 23, Authorised, Last updated: 31/08/2022 -
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Human medicine European public assessment report (EPAR): Mysildecard
sildenafil citrate, Hypertension, Pulmonary
Date of authorisation: 15/09/2016,, Revision: 6, Authorised, Last updated: 04/07/2022
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Human medicine European public assessment report (EPAR): Travatan
travoprost, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 27/11/2001, Revision: 30, Authorised, Last updated: 07/06/2022 -
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Human medicine European public assessment report (EPAR): Invirase
saquinavir, HIV Infections
Date of authorisation: 03/10/1996, Revision: 49, Authorised, Last updated: 20/10/2022