7172 results
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Generic and biosimilar medicines in the centralised procedure: 3rd EMA-EGA information day
London, 10/11/2010, Last updated: 09/11/2010centralised procedure: 3rd EMA-EGA information day … Generic medicines Association (EGA) on generic and biosimilar … one day event is open to EGA members only. Documents Agenda … -
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Second EMEA - EGA Info Day - Generic and Biosimilar Medicines in the Centralised Procedure
London, 03/10/2008, Last updated: 01/10/2008Second EMEA - EGA Info Day - Generic and Biosimilar … Documents Agenda - Second EMEA - EGA Info Day; Generic and Biosimilar … Centralised Procedure - For EGA Members Only PDF icon application/pdf … -
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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): Lumigan
bimatoprost, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 08/03/2002, Revision: 37, Authorised, Last updated: 20/07/2022has also been compared with latanoprost (another prostaglandin analogue … been compared with that of latanoprost in another study in 437 patients … also more effective than latanoprost, with patients using Lumigan … -
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Human medicine European public assessment report (EPAR): Travatan
travoprost, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 27/11/2001, Revision: 30, Authorised, Last updated: 07/06/2022included a comparison with latanoprost (another prostaglandin analogue … timolol and as effective as latanoprost in reducing intraocular pressure … included a comparison with latanoprost (another prostaglandin analogue … -
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Human medicine European public assessment report (EPAR): DuoTrav
travoprost, timolol, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 23/04/2006, Revision: 18, Authorised, Last updated: 08/10/2021containing a combination of latanoprost (another prostaglandin analogue … eye drops containing both latanoprost and timolol. What is the … containing a combination of latanoprost (another prostaglandin analogue … -
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Human medicine European public assessment report (EPAR): Tarceva (updated)
erlotinib, Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms
Date of authorisation: 19/09/2005, Revision: 32, Authorised, Last updated: 16/05/2023epidermal 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): 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): Orgalutran
ganirelix, Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female
Date of authorisation: 16/05/2000, Revision: 24, Authorised, Last updated: 04/04/2023ovulation (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 … -
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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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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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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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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): 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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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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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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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): 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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Human medicine European public assessment report (EPAR): Cetrotide
cetrorelix (as acetate), Ovulation; Ovulation Induction
Date of authorisation: 12/04/1999, Revision: 27, Authorised, Last updated: 12/04/2023ovulation (early release of eggs from the ovary). It is given … stimulated to produce more eggs). The medicine can only be … ovulation (the release of eggs) is planned. Because of the … -
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Human medicine European public assessment report (EPAR): Puregon
follitropin beta, Infertility; Hypogonadism
Date of authorisation: 02/05/1996, Revision: 34, Authorised, Last updated: 29/03/2023anovulatory (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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National expert: Anna-Bettina Haidich, National Organization For Medicines (updated)
- Declaration of interests - 39.28 KB | PDF
- Curriculum Vitae - 78.75 KB | PDF