94 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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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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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: 04/08/2015benzoate metformin fluconazole eletriptan rizatriptan ebastine ibuprofen desmopressin aciclovir levetiracetam irbesartan venlafaxine ciprofloxacin cefpodoxime … -
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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 … -
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National expert: Maria Del Val Bermejo Sanz, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 41.53 KB | PDF
- Curriculum Vitae - 37.65 KB | PDF
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Human medicine European public assessment report (EPAR): Myfenax (updated)
mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008,
, Revision: 27, Authorised, Last updated: 26/09/2023
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Human medicine European public assessment report (EPAR): Imatinib Teva (updated)
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 07/01/2013,, Revision: 19, Authorised, Last updated: 28/09/2023
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Human medicine European public assessment report (EPAR): Lumeblue (previously known as Methylthioninium chloride Cosmo) (updated)
methylthioninium chloride, Colorectal Neoplasms; Colonoscopy
Date of authorisation: 19/08/2020, Revision: 3, Authorised, Last updated: 18/09/2023 -
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Human medicine European public assessment report (EPAR): CellCept
mycophenolate mofetil, Graft Rejection
Date of authorisation: 14/02/1996, Revision: 38, Authorised, Last updated: 17/03/2023 -
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Human medicine European public assessment report (EPAR): Livtencity
Maribavir, Cytomegalovirus Infections
Date of authorisation: 09/11/2022,
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, Revision: 4, Authorised, Last updated: 05/07/2023
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Human medicine European public assessment report (EPAR): Translarna
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,, , 
, Revision: 22, Authorised, Last updated: 25/04/2023
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Human medicine European public assessment report (EPAR): Myclausen
mycophenolate mofetil, Graft Rejection
Date of authorisation: 07/10/2010,, Revision: 15, Authorised, Last updated: 04/08/2022
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Human medicine European public assessment report (EPAR): Mycophenolate mofetil Teva
mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008,, Revision: 25, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Tacforius
tacrolimus monohydrate, Liver Transplantation; Kidney Transplantation
Date of authorisation: 08/12/2017,, Revision: 7, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Glivec
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Gastrointestinal Stromal Tumors; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 07/11/2001,, Revision: 45, Authorised, Last updated: 29/03/2023
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Human medicine European public assessment report (EPAR): Gilenya (updated)
fingolimod hydrochloride , Multiple Sclerosis
Date of authorisation: 17/03/2011, Revision: 36, Authorised, Last updated: 15/09/2023 -
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Human medicine European public assessment report (EPAR): Imatinib Accord
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 30/06/2013,, Revision: 20, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Vemlidy
tenofovir alafenamide fumarate, Hepatitis B
Date of authorisation: 09/01/2017, Revision: 16, Authorised, Last updated: 31/05/2023 -
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Human medicine European public assessment report (EPAR): Dupixent
dupilumab, Dermatitis, Atopic; Prurigo; Esophageal Diseases; Asthma; Sinusitis
Date of authorisation: 26/09/2017, Revision: 29, Authorised, Last updated: 17/08/2023 -
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Human medicine European public assessment report (EPAR): Imatinib Actavis
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 17/04/2013,, Revision: 13, Withdrawn, Last updated: 05/07/2022
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Human medicine European public assessment report (EPAR): Lemtrada
alemtuzumab, Multiple Sclerosis
Date of authorisation: 12/09/2013,, Revision: 21, Authorised, Last updated: 10/07/2023
patients were administered aciclovir 200 mg twice a day or equivalent … -
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Human medicine European public assessment report (EPAR): Oxervate
Recombinant human nerve growth factor, Keratitis
Date of authorisation: 06/07/2017,, 
, , Revision: 2, Authorised, Last updated: 02/06/2023
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Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,, , 
, Revision: 15, Authorised, Last updated: 15/06/2023