27 results
Keyword Levocetirizine Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): levocetirizine, montelukast
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oto-rhino-laryngology; Pneumology-allergology
PIP number: EMEA-002646-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Powder for oral solution
Decision date: 10/02/2020, Last updated: 10/06/2020, Compliance check: XActive substance levocetirizine montelukast Therapeutic area … levocetirizine montelukast … -
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Opinion/decision on a Paediatric investigation plan (PIP): levocetirizine (dihydrochloride), Montelukast sodium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001908-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/04/2016, Last updated: 02/06/2016, Compliance check: XKey facts P/0114/2016 levocetirizine (dihydrochloride) Montelukast … for montelukast (sodium) / levocetirizine (dihydrochloride) (EMEA-001908-PIP01-15 … for montelukast (sodium) / levocetirizine (dihydrochloride) (EMEA-001908-PIP01-15 … -
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National expert: José Javier Sawchik Monegal, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 79.84 KB | PDF
- Curriculum Vitae - 19.91 KB | PDF
of results of the study "Levocetirizine does not prolong the QT/QTc … -
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National expert: Carmen Maria Salavastru, European Medicines Agency (updated)
- Declaration of interests - 83.08 KB | PDF
- Curriculum Vitae - 25.99 KB | PDF
Binlastine 20 mg once daily and levocetirizine 5 mg for the treatment of … -
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Human medicine European public assessment report (EPAR): Xolair (updated)
omalizumab, Asthma; Urticaria
Date of authorisation: 25/10/2005, Revision: 44, Authorised, Last updated: 01/02/2023 -
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Human medicine European public assessment report (EPAR): Neoclarityn
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Revision: 45, Authorised, Last updated: 15/12/2022 -
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Human medicine European public assessment report (EPAR): Azomyr
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Revision: 51, Authorised, Last updated: 15/12/2022 -
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,
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, Revision: 35, Authorised, Last updated: 22/12/2022
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Withdrawn application: Lunivia
date of withdrawal: 13/05/2009, Initial authorisation, Last updated: 15/05/2009 -
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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: 04/08/2015 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 March 2018
European Medicines Agency, London, UK, from 05/03/2018 to 08/03/2018, Last updated: 05/03/2018 -
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Paediatric Committee (PDCO): 24-26 February 2016
European Medicines Agency, London, UK, from 24/02/2016 to 26/02/2016, Last updated: 24/02/201610 2.1.9. Levocetirizine dihydrochloride / Montelukast … -
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Press release: GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies
CHMP, Last updated: 23/01/2015 -
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Paediatric Committee (PDCO): 27-29 January 2016
European Medicines Agency, London, UK, from 27/01/2016 to 29/01/2016, Last updated: 30/06/2014 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 18/01/2023 -
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PDCO: meeting archive 2015-2017
Last updated: 19/04/2022 -
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News: EMA's medical literature monitoring enters into full operation
Last updated: 01/09/2015 -
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News: Safety monitoring of medicines: EMA to screen medical literature for 400 active substance groups
Last updated: 12/05/2015 -
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Guidance documents
Last updated: 19/07/2022 -
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News: Progress on science, medicines and health
Last updated: 10/05/2017 -
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Periodic safety update reports (PSURs)
Last updated: 27/07/2022 -
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News: Feedback requested on the draft list of EU reference dates for periodic safety update reports in preparation for introduction of the new pharmacovigilance legislation
Last updated: 04/04/2012 -
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Annual reports and work programmes
Last updated: 10/06/2022 -
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Pharmacovigilance: Regulatory and procedural guidance
Last updated: 29/04/2016