11625 results
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Opinion/decision on a Paediatric investigation plan (PIP): Aciclovir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-001066-PIP02-11-M03, Route(s) of administration: Gingival use, Pharmaceutical form(s): Muco-adhesive buccal tablet
Decision date: 04/12/2019, Last updated: 01/04/2020, Compliance check: XSitavig and associated names Aciclovir Infectious diseasesP/0412/2019EMEA-001066-PIP02-11-M03 … paediatric investigation plan for aciclovir (Sitavig and associated names … Aciclovir … -
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Opinion/decision on a Paediatric investigation plan (PIP): Aciclovir
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001066-PIP01-10, Route(s) of administration: Gingival use, Pharmaceutical form(s): Muco-adhesive buccal tablet
Decision date: 06/04/2011, Last updated: 12/05/2011, Compliance check: XKey facts Aciclovir Infectious diseasesP/83/2011EMEA-001066-PIP01-10 … product specific waiver for aciclovir (EMEA-001066-PIP01-10) PDF … product specific waiver for aciclovir (EMEA-001066-PIP01-10) in … -
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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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Opinion/decision on a Paediatric investigation plan (PIP): Aciclovir, hydrocortisone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-000110-PIP01-07, Route(s) of administration: Topical use, Pharmaceutical form(s): Cream
Decision date: 15/08/2008, Last updated: 18/09/2008, Compliance check: XKey facts Aciclovir hydrocortisone Infectious … Paediatric Investigation Plan for aciclovir, hydrocortisone, (EMEA-000110-PIP01-07 … Word - Decision and Opinion aciclovir - hydrocortisone 000110-PIP… … -
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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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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 … benzoate metformin fluconazole eletriptan rizatriptan ebastine ibuprofen desmopressin aciclovir levetiracetam irbesartan venlafaxine ciprofloxacin cefpodoxime … -
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Promoting the authorisation of alternatives to antimicrobial veterinary medicinal products in the EU
Last updated: 26/07/2021omoting the authorisation of alternatives to antimicrobial veterinary … ‘Promoting the authorisation of alternatives to antimicrobial veterinary … promote the authorisation of alternatives to antimicrobials in the …
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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
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 …
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Referral: Valtrex
valaciclovir, associated names: Zelitrex, Talavir, Valaciclovir Allen, Valherpes, Article 30 referrals
Status: European Commission final decision, opinion/position date: 22/04/2010, EC decision date: 13/07/2010, Last updated: 25/03/2014body into two substances, aciclovir and valine (an amino-acid Aciclovir is an antiviral that works … body into two substances, aciclovir and valine (an amino-acid … and valine (an amino-acid). Aciclovir is an antiviral that works … -
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Orphan designation: Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes for: Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity
Date of designation: 09/08/2012, Withdrawn, Last updated: 21/02/2019several antiviral medicines (aciclovir, ganciclovir, valaciclovir … condition; the existence of alternative methods of diagnosis, prevention … -
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Human medicine European public assessment report (EPAR): Invirase
saquinavir, HIV Infections
Date of authorisation: 03/10/1996, Revision: 48, Authorised, Last updated: 25/11/2021liver, 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): 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): Vyxeos liposomal (previously known as Vyxeos)
daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018,
, Revision: 6, Authorised, Last updated: 24/03/2022
a poor prognosis and few alternatives. The side effects were similar … -
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Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle)
insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021,, , Revision: 1, Authorised, Last updated: 14/09/2021
infusion 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): 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): Vantobra (previously Tobramycin PARI)
Tobramycin, Respiratory Tract Infections; Cystic Fibrosis
Date of authorisation: 18/02/2019, Revision: 3, Authorised, Last updated: 13/04/2021nebuliser, would be a useful alternative. In addition, it takes less … hours. Vantobra is taken in alternating cycles of 28 days. A cycle … is evident, additional or alternative anti-pseudomonal therapy … -
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Human medicine European public assessment report (EPAR): NovoRapid
insulin aspart, Diabetes Mellitus
Date of authorisation: 07/09/1999, Revision: 31, Authorised, Last updated: 23/11/2020infusion 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): Zirabev
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019,, , Revision: 10, Authorised, Last updated: 29/03/2022
paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan … paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan … -
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Human medicine European public assessment report (EPAR): Ameluz
5-aminolevulinic acid hydrochloride, Keratosis, Actinic; Carcinoma, Basal Cell
Date of authorisation: 13/12/2011, Revision: 19, Authorised, Last updated: 23/03/2022somewhat safer than the standard alternative. The Agency therefore concluded … -
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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): CellCept
mycophenolate mofetil, Graft Rejection
Date of authorisation: 14/02/1996, Revision: 37, Authorised, Last updated: 02/03/2022unless there is no suitable alternative to prevent rejection of the … unless there is no suitable alternative to prevent rejection of the … -
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Human medicine European public assessment report (EPAR): Busilvex
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 09/07/2003, Revision: 19, Authorised, Last updated: 09/02/2022either cyclophosphamide or an alternative medicine, melphalan, in children … Busilvex also provides an alternative to busulfan tablets, which … marketing authorisations as alternative suppliers or formulations …