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EMEA - EGA Info Day on Generic and Biosimilar Medicinal Products and the Centralised Procedure
London, 25/11/2006, Last updated: 25/11/2006EMEA - EGA Info Day on Generic and Biosimilar … Documents Agenda - EMEA - EGA Info Day on Generic and Biosimilar … Centralised Procedure - For EGA members only PDF icon application/pdf … -
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Human medicine European public assessment report (EPAR): Bondenza (previously Ibandronic Acid Roche)
ibandronic acid, Osteoporosis, Postmenopausal
Date of authorisation: 23/02/2004, Revision: 16, Withdrawn, Last updated: 13/05/2013Roche)EMEA/H/C/000502ibandronic acidibandronic acidOsteoporosis, PostmenopausalM05BA06 Publication … -
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Human medicine European public assessment report (EPAR): Ebymect (updated)
dapagliflozin propanediol monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/11/2015, Revision: 18, Authorised, Last updated: 06/03/2023any form of acute metabolic acidosis (build up of acid in the … called ketones) or lactic acidosis (build-up of lactic acid … assessed more frequently, e.g. every 3-6 months. The maximum … -
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Human medicine European public assessment report (EPAR): Xigduo (updated)
metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 16/01/2014, Revision: 19, Authorised, Last updated: 06/03/2023any form of acute metabolic acidosis (build up of acid in the … ‘ketones’) or lactic acidosis (build-up of lactic acid … marketing authorisation (e.g. summary of product characteristics … -
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Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of distal renal tubular acidosis
Date of designation: 20/06/2017, Withdrawn, Last updated: 03/05/2021treatment of distal renal tubular acidosis. The sponsor’s address was … What is distal renal tubular acidosis? Distal renal tubular acidosis is a kidney disease in which … type of distal renal tubular acidosis, usually first detected in … -
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National expert: Eva Bermejo-Sanchez, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 64.7 KB | PDF
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Human medicine European public assessment report (EPAR): Stribild
elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 24/05/2013, Revision: 25, Authorised, Last updated: 02/02/2023been seen including lactic acidosis (excess lactic acid in the … been seen including lactic acidosis (excess lactic acid in the … -
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Human medicine European public assessment report (EPAR): Iressa
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 24/06/2009, Revision: 15, Authorised, Last updated: 05/07/2022epidermal-growth-factor receptor (EGFR). How is Iressa used? Treatment … of cancer cells, such as EGFR on the surface of non-small-cell-lung-cancer … non-small-cell-lung-cancer cells. EGFR is involved in the growth … -
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Human medicine European public assessment report (EPAR): Tarceva
erlotinib, Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms
Date of authorisation: 19/09/2005, Revision: 30, Authorised, Last updated: 18/08/2021epidermal growth factor receptor (EGFR); patients with EGFR activating mutations whose … treat cancer); patients with EGFR activating mutations in whom … worked; patients without EGFR activating mutations in whom … -
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Human medicine European public assessment report (EPAR): GONAL-f
follitropin alfa, Anovulation; Reproductive Techniques, Assisted; Infertility, Female; Hypogonadism
Date of authorisation: 20/10/1995, Revision: 25, Authorised, Last updated: 06/09/2022over) who do not produce eggs and do not respond to treatment … stimulates the ovaries to produce eggs); adult women who are undergoing … to produce more than one egg at a time; adult women with … -
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Human medicine European public assessment report (EPAR): Gefitinib Mylan
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 27/09/2018,
, Revision: 5, Authorised, Last updated: 17/06/2022
epidermal growth factor receptor (EGFR). Gefitinib Mylan contains … of cancer cells, such as EGFR on the surface of non-small … non-small cell lung cancer cells. EGFR is involved in the growth … -
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Veterinary medicine European public assessment report (EPAR): Vectormune ND
cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain, Chicken; Embryonated eggs
Date of authorisation: 08/09/2015, Revision: 7, Authorised, Last updated: 06/09/2021watery diarrhoea and reduced egg production. MD is a herpesvirus … directly into 18-day-old eggs containing embryos (unhatched … layers (chickens bred for egg production). For MD protection … -
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Veterinary medicine European public assessment report (EPAR): MS-H Vaccine
Mycoplasma synoviae strain MS-H, Chicken
Date of authorisation: 14/06/2011, Revision: 6, Authorised, Last updated: 03/06/2021with poor quality of the eggshell. MS-H Vaccine is used … chickens intended to produce eggs for broilers (for meat) and … for meat) and layers (for egg production) to reduce the … -
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Human medicine European public assessment report (EPAR): Tagrisso
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,
, Revision: 17, Authorised, Last updated: 29/11/2022
gene for a protein called EGFR. • In patients whose cancer … confirm that the patient has an EGFR mutation. Tagrisso is available … It blocks the activity of EGFR, which normally controls growth … -
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Veterinary medicine European public assessment report (EPAR): Innovax-ND-IBD
Cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of ND virus and the VP2 protein of IBD virus, Chicken; Embryonated chicken eggs
Date of authorisation: 22/08/2017, Revision: 5, Authorised, Last updated: 04/11/2021watery diarrhoea and reduced egg production. IBD, also known … into 18-19-day-old chicken eggs containing embryos (unhatched … of vaccination of chicken eggs: for ND, 92% of chickens from … -
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Human medicine European public assessment report (EPAR): Vizimpro
dacomitinib monohydrate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 02/04/2019,
, Revision: 2, Authorised, Last updated: 21/07/2021
epidermal growth factor receptor (EGFR). Vizimpro contains the active … presence of mutations in the EGFR gene should be confirmed … It blocks the activity of EGFR, which normally controls growth … -
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Human medicine European public assessment report (EPAR): Ganirelix Gedeon Richter
ganirelix acetate, Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female
Date of authorisation: 15/07/2022,, Authorised, Last updated: 20/07/2022
ovulation (early release of eggs from the ovary) in women … so that they produce more eggs). Ganirelix Gedeon Richter … in the ovary that hold the eggs) to allow … -
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Veterinary medicine European public assessment report (EPAR): Vaxxitek HVT+IBD
Recombinant turkey herpesvirus, strain vhvt013-69, live, Embryonated eggs; Chicken
Date of authorisation: 09/08/2002, Revision: 17, Authorised, Last updated: 07/01/2022injected into chickens and into eggs where chicks are developing … chickens and chicks in the egg without presenting any apparent … chickens and chicks in the egg against Infectious Bursal … -
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Human medicine European public assessment report (EPAR): Puregon
follitropin beta, Infertility; Hypogonadism
Date of authorisation: 02/05/1996, Revision: 33, Authorised, Last updated: 19/11/2021anovulatory (do not produce eggs) and do not respond to treatment … to produce more than one egg at a time. Puregon can also … stimulates the production of eggs, and in men, it stimulates … -
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Human medicine European public assessment report (EPAR): Rybrevant
amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021,, 
, Revision: 2, Authorised, Last updated: 30/01/2023
epidermal growth factor receptor (EGFR), and are known as ‘activating … are known as ‘activating EGFR exon 20 insertion mutations’ … Rybrevant work? In NSCLC cells, EGFR is often overactive, causing … -
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Orphan designation: Sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate for: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
Date of designation: 21/08/2020, Positive, Last updated: 25/11/2020encephalomyopathy, lactic acidosis, and stroke-like episodes … encephalomyopathy, lactic acidosis, and stroke-like episodes … encephalomyopathy, lactic acidosis, and stroke-like episodes … -
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Veterinary medicine European public assessment report (EPAR): Ultifend ND IBD
Turkey herpes virus, strain rHVT/ND/IBD, expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus, live recombinant, Embryonated chicken eggs; Chicken
Date of authorisation: 20/04/2021, Authorised, Last updated: 21/09/2021watery diarrhoea and reduced egg production. IBD (also known … directly into 18-day-old chicken eggs containing embryos (unhatched … 18-day-old chicken embryonated eggs to reduce death, clinical … -
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Human medicine European public assessment report (EPAR): Erbitux
cetuximab, Head and Neck Neoplasms; Colorectal Neoplasms
Date of authorisation: 29/06/2004, Revision: 29, Authorised, Last updated: 25/05/2022epidermal growth factor receptor (EGFR) and contain ‘wild-type’ … been designed to attach to EGFR, which can be found on the … surface of some tumour cells. EGFR is involved in switching … -
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Veterinary medicine European public assessment report (EPAR): Innovax-ND-ILT
Cell-associated live recombinant turkey herpesvirus (strain HVT/NDV/ILT) expressing the fusion protein of newcastle disease virus and the glycoproteins gD and gI of infectious laryngotracheitis virus, Embryonated chicken eggs; Chicken
Date of authorisation: 16/09/2020, Revision: 1, Authorised, Last updated: 24/03/2021watery diarrhoea and reduced egg production. MD is a herpesvirus … respiratory signs, decreased egg production, thin egg shells, lack of growth, neurological … into 18-19-day-old chicken eggs containing embryos (unhatched … -
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Human medicine European public assessment report (EPAR): Orgalutran
ganirelix, Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female
Date of authorisation: 16/05/2000, Revision: 23, Authorised, Last updated: 10/11/2021ovulation (early release of eggs from the ovary) in women … so that they produce more eggs). In premature ovulation, the … ovulation, the ovaries release eggs that may be immature and …