12267 results
Keyword Nimesulide Alter Remove keyword
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Referral: Nimesulide
nimesulide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/06/2011, EC decision date: 20/01/2012, Last updated: 19/04/2012Nimesulide … systemic medicines containing nimesulide (capsules, tablets, suppositories … concluded that the benefits of nimesulide used systemically continue … -
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Referral: Nimesulide
nimesulide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/12/2003, EC decision date: 26/04/2004, Last updated: 13/05/2004Nimesulide … Commission final decision Overview Nimesulide is a non-steroidal anti-inflammatory … anti-inflammatory drug (NSAID). Nimesulide containing medicinal products … -
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Referral: Nimesulide
nimesulide, associated names: Aulin, Nimed, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 20/09/2007, EC decision date: 16/10/2009, Last updated: 21/09/2007Nimesulide … liver in patients taking nimesulide reported since April 2007 … effect that a suspension of nimesulide would have on the rates of … -
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Herbal medicinal product: Melaleucae aetheroleum
Melaleuca alternifolia (Maiden and Betche) Cheel, Tea-tree oil, F: Assessment finalised, Last updated: 15/03/2022branches of the trees Melaleuca alternifolia Cheel, M. linariifolia Smith … Tea tree oil Melaleuca alternifolia (Maiden and Betch) Cheel … branches of the trees Melaleuca alternifolia Cheel, M. linariifolia Smith … -
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Press release: European Medicines Agency concludes review of systemic nimesulide-containing medicines
CHMP, Last updated: 23/06/2011concludes review of systemic nimesulide-containing medicines … concludes review of systemic nimesulide-containing medicines … concludes review of systemic nimesulide-containing medicines 7 Westferry … -
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Press release: European Medicines Agency recommends restricted use of nimesulide-containing medicinal products
Last updated: 21/09/2007recommends restricted use of nimesulide-containing medicinal products … recommends restricted use of nimesulide-containing medicinal products … Microsoft Word - Nimesulide Press release_restriction … -
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Clinical efficacy and safety: blood products (including biotech alternatives)
Last updated: 11/02/2016products (including biotech alternatives) …
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Promoting the authorisation of alternatives to antimicrobial veterinary medicinal products in the EU - Scientific guideline
Last updated: 26/07/2021omoting the authorisation of alternatives to antimicrobial veterinary … omoting the authorisation of alternatives to antimicrobial veterinary … promoting the authorisation of alternatives to antimicrobial veterinary …
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Press release: Acipimox only to be used as additional or alternative treatment to reduce high triglyceride levels
CMDh, Last updated: 20/12/2013be used as additional or alternative treatment to reduce high … only as an additional or alternative treatment in type IIb and … role as an additional or alternative treatment to reduce triglycerides … -
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Press release: PRAC recommends using acipimox only as additional or alternative treatment to lower high triglyceride levels
PRAC, Last updated: 08/11/2013acipimox only as additional or alternative treatment to lower high triglyceride … acipimox only as additional or alternative treatment to lower high triglyceride … acipimox only as additional or alternative treatment to lower high triglyceride … -
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Replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products - Scientific guideline
Last updated: 23/04/2009rabbit pyrogen testing by an alternative test for plasma derived medicinal … rabbit pyrogen testing by an alternative test for plasma derived medicinal … RABBIT PYROGEN TESTING BY AN ALTERNATIVE TEST FOR PLASMA DERIVED MEDICINAL …
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,17-20 September 2007
CHMP, Last updated: 21/09/2007Human Use recommendation on nimesulide-containing medicines PDF icon application/pdf … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 15-18 February 2010
CHMP, Last updated: 19/02/2010Review of nimesulide started … EMA/CHMP/95106/2010 Page 4/4 Review of nimesulide started The Committee started … the benefits and risks of nimesulide-containing medicinal products for systemic … -
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National expert: Miguel-Angel Macia, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 22.52 KB | PDF
Committee on Drug Safety, Spain alternate member of the Pharmacovigilance … Prescribing Patterns of Codeine and Alternative Medicines in Children in … Therapies (CAT) member or alternate Not a CAT member or alternate CONFIDENTIALITY UNDERTAKING In … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)20-23 June 2011
CHMP, Last updated: 24/06/2011Review of systemic nimesulide-containing medicines concluded … website. Review of systemic nimesulide-containing medicines concluded The … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,18-21 February 2008
CHMP, Last updated: 21/02/20083% gel, (nimesulide) from Zentiva A.S., recommending … -
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Press release: Press Release on the cardiovascular safety of non-selective NSAIDs
Last updated: 02/08/2005Nabumetone, Naproxen and Nimesulide. A previous review had identified … Nabumetone, Naproxen and Nimesulide. 2. A previous review had … Nabumetone, Naproxen and Nimesulide. As part of the review on … -
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Human medicine European public assessment report (EPAR): Farydak
panobinostat lactate anhydrous, Multiple Myeloma
Date of authorisation: 28/08/2015,, Revision: 11, Authorised, Last updated: 05/04/2022
medical need, it offers a new alternative. Although the side effects … subgroup in view of the lack of alternatives, and could be managed. The … -
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Human medicine European public assessment report (EPAR): Multaq
dronedarone, Atrial Fibrillation
Date of authorisation: 25/11/2009, Revision: 18, Authorised, Last updated: 25/11/2022only be prescribed after alternative treatment options have been … prolonged ‘QTc Bazett’ (an alteration of the electrical activity … -
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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: 20/10/2022liver, QT prolongation (an alteration of the electrical activity … another type of heart activity alteration); midazolam taken by mouth … electrocardiogram (ECG). These indicate alterations of the electrical activity … -
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Human medicine European public assessment report (EPAR): Torisel
Temsirolimus, Carcinoma, Renal Cell; Lymphoma, Mantle-Cell
Date of authorisation: 19/11/2007, Revision: 33, Authorised, Last updated: 21/06/2022found more effective than alternative cancer medicines (such as … Torisel or the most appropriate alternative cancer medicines chosen by … months in those receiving the alternative treatment. What are the risks … -
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Human medicine European public assessment report (EPAR): Lumykras
sotorasib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/01/2022,,
, Revision: 1, Authorised, Last updated: 29/11/2022
KRAS gene can produce an altered protein that causes the uncontrolled … sotorasib, attaches to this altered protein inside cancer cells … KRAS gene can produce an altered protein that causes the uncontrolled … -
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Human medicine European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos)
daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018,, Revision: 8, Authorised, Last updated: 10/11/2022
a poor prognosis and few alternatives. The side effects were similar … -
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Human medicine European public assessment report (EPAR): Equidacent
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell
Date of authorisation: 24/09/2020,,
, Revision: 3, Withdrawn, Last updated: 25/11/2021
paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan … -
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Human medicine European public assessment report (EPAR): Xerava
eravacycline, Infection; Bacterial Infections
Date of authorisation: 20/09/2018,, Revision: 4, Authorised, Last updated: 19/08/2021
shown to be as effective as alternative antibiotics in 2 main studies … Xerava is as effective as alternative antibiotics in treating infections … measures should be taken and alternative antimicrobial treatment should …