12295 results
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Referral: Escitalopram
escitalopram, Article 30 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 18/02/2010, Last updated: 29/09/2010Escitalopram … review of a group of generic escitalopram-containing medicines that were authorised … issued in due course. What is escitalopram? Escitalopram is an antidepressant used … -
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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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Referral: Serotonin-specific reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors
atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 19/08/2005, Last updated: 03/11/2005atomoxetine, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine … atomoxetine, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine … citalopram, duloxetine 1 , escitalopram, fluoxetine,fluvoxamine, mianserine … -
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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: 04/08/2015importance for patients because alternatives cannot meet patients' needs … acid ropinirole cefpodoxime quetiapine trimetazidine bosentan tramadol paracetamol escitalopram trimetazidine hydrochloride entacapone valsartan hydrochlorothiazide donepezil … hydrochloride clopidogrel hydrochloride escitalopram oxalate metformin hydrochloride trimetazidine … -
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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 (CHMP), 15-18 February 2010
CHMP, Last updated: 19/02/2010Referral on escitalopram concluded … granted. Referral on escitalopram concluded The Committee … authorisations of generic escitalopram-containing medicinal products from … -
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News: European Medicines Agency finalises review of antidepressants in children and adolescents
CHMP, Last updated: 25/04/2005atomoxetine, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine … citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine … citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine … -
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National expert: Jogin Thakore, European Medicines Agency (updated)
- Declaration of interests - 83 KB | PDF
- Curriculum Vitae - 30.16 KB | PDF
01/1999-07/2014 Lundbeck Escitalopram Citalopram Depression 01/2009-12/2012 … Therapies (CAT) member or alternate Not a CAT member or alternate Thakore 2022-10-27 3 Classified … -
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National expert: Giacomo Capone, Italian Medicines Agency (updated)
- Declaration of interests - 79.77 KB | PDF
- Curriculum Vitae - 20.86 KB | PDF
2018 Apr "Stress induces altered CRE/CREB pathway activity … quot;Time-dependent effects of escitalopram on brain derived neurotrophic … Therapies (CAT) member or alternate Not a CAT member or alternate CONFIDENTIALITY UNDERTAKING In … -
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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): NovoRapid (updated)
insulin aspart, Diabetes Mellitus
Date of authorisation: 07/09/1999, Revision: 32, Authorised, Last updated: 22/03/2023infusion under the skin or alternatively, it can be given into a vein … infusion under the skin or alternatively, it can be given into a vein … -
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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): Invirase (updated)
saquinavir, HIV Infections
Date of authorisation: 03/10/1996, Revision: 50, Authorised, Last updated: 13/03/2023liver, 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): Lumykras
sotorasib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/01/2022,
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, 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 … -
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Human medicine European public assessment report (EPAR): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,, , , Revision: 1, Authorised, Last updated: 17/01/2023
tocilizumab (or a suitable alternative when tocilizumab is unavailable … Tocilizumab, or suitable alternatives in case of its unavailability … tocilizumab (or a suitable alternative when tocilizumab is unavailable … -
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Human medicine European public assessment report (EPAR): Cyanokit
hydroxocobalamin, Poisoning
Date of authorisation: 23/11/2007, Revision: 10, Authorised, Last updated: 18/01/2019seen with Cyanokit and with alternatives. However, the CHMP concluded … Cyanokit had advantages over alternative antidotes because it has … seen with Cyanokit and with alternatives. However, the CHMP concluded … -
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Human medicine European public assessment report (EPAR): Mvasi
bevacizumab, Carcinoma, Renal Cell; Peritoneal Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Fallopian Tube Neoplasms
Date of authorisation: 15/01/2018,, Revision: 14, Authorised, Last updated: 05/01/2023
paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan …