115 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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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2012
CHMP, Last updated: 14/12/2012Fenofibrato Pensa, Fenofibrato Ranbaxy INN fenofibrate … -
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National expert: Christopher Jarvis, European Medicines Agency (updated)
- Declaration of interests - 39.3 KB | PDF
- Curriculum Vitae - 27.24 KB | PDF
Nucleoside Analogues with Aciclovir. 4th Annual Skin Network Meeting … -
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National expert: Michela Piezzo, Italian Medicines Agency (updated)
- Declaration of interests - 39.41 KB | PDF
- Curriculum Vitae - 33.61 KB | PDF
G, Martinelli C, Nuzzo F, Pensabene M, Laurentiis M. Targeting … Iodice G, Nuzzo F, Pacilio C, Pensabene M and De Laurentiis M. Progression_Free … -
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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): 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): Temodal
temozolomide, Glioma; Glioblastoma
Date of authorisation: 26/01/1999, Revision: 36, Authorised, Last updated: 22/02/2023Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide … that markets Fenofibrato Pensa and Fenofibrato Ranbaxy … should); Fenofibrato Pensa and Fenofibrato Ranbaxy … -
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Human medicine European public assessment report (EPAR): Translarna
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,
, 
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, Revision: 22, Authorised, Last updated: 25/04/2023
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Human medicine European public assessment report (EPAR): Tygacil
Tigecycline, Bacterial Infections; Skin Diseases, Bacterial; Soft Tissue Infections
Date of authorisation: 24/04/2006, Revision: 34, Authorised, Last updated: 11/10/2022Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide … that markets Fenofibrato Pensa and Fenofibrato Ranbaxy … should); Fenofibrato Pensa and Fenofibrato Ranbaxy … -
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Human medicine European public assessment report (EPAR): Livtencity
Maribavir, Cytomegalovirus Infections
Date of authorisation: 09/11/2022,, , Revision: 3, Authorised, Last updated: 17/03/2023
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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): 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): 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): 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): Myfenax
mycophenolate mofetil, Graft Rejection
Date of authorisation: 21/02/2008,, Revision: 26, Authorised, Last updated: 23/06/2022
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Human medicine European public assessment report (EPAR): Vemlidy (updated)
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): Ribavirin Teva
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 31/03/2009,, Revision: 15, Withdrawn, Last updated: 09/07/2021
Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide … that markets Fenofibrato Pensa and Fenofibrato Ranbaxy … should); Fenofibrato Pensa and Fenofibrato Ranbaxy … -
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Human medicine European public assessment report (EPAR): Oxervate (updated)
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): Ribavirin Teva Pharma B.V.
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 01/07/2009,, Revision: 14, Withdrawn, Last updated: 09/07/2021
Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide … that markets Fenofibrato Pensa and Fenofibrato Ranbaxy … should); Fenofibrato Pensa and Fenofibrato Ranbaxy … -
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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