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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): Tecentriq
atezolizumab, Carcinoma, Transitional Cell; Carcinoma, Non-Small-Cell Lung; Urologic Neoplasms; Breast Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 20/09/2017, Revision: 21, Authorised, Last updated: 07/03/2023a type of cancer known as EGFR mutant or ALK-positive NSCLC … early-stage NSCLC without EGFR or ALK mutations in which … a type of cancer known as EGFR mutant or ALK-positive NSCLC … -
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Human medicine European public assessment report (EPAR): Libtayo (updated)
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,
, Revision: 14, Authorised, Last updated: 17/05/2023
EGFR, … no mutations in the genes EGFR, ALK and ROS1 involved in … cells and no mutations in the EGFR, ALK and ROS1 genes. • … -
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Orphan designation: 2-isopropyl-3H-naphtho[1,2-d]imidazole-4,5-dione for: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
Date of designation: 12/12/2017, Positive, Last updated: 03/02/2021encephalomyopathy, lactic acidosis and stroke-like episodes … encephalomyopathy, lactic acidosis and stroke-like episodes … encephalomyopathy, lactic acidosis and stroke-like episodes … -
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Human medicine European public assessment report (EPAR): Giotrif
afatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 25/09/2013, Revision: 14, Authorised, Last updated: 21/04/2021gene for a protein called EGFR and has not been previously … non-small cell lung cancer. EGFR proteins are part of the … cancer cells with mutated EGFR proteins are particularly … -
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Human medicine European public assessment report (EPAR): Pergoveris (updated)
follitropin alfa, lutropin alfa, Infertility, Female
Date of authorisation: 25/06/2007, Revision: 15, Authorised, Last updated: 31/05/2023the ovaries that contain an egg. Pergoveris is for adult women … stimulates the production of eggs, and LH stimulates their release … follicle, which will release an egg after an injection of the … -
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Referral: Gadolinium-containing contrast agents
gadobenic acid, gadobutrol, gadodiamide, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide, gadoxetic acid, associated names: Optimark, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/07/2017, EC decision date: 23/11/2017, Last updated: 04/12/2017agents are not suitable (e.g. for liver scans). Gadolinium … agents are not suitable (e.g. for liver scans). • … -
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Human medicine European public assessment report (EPAR): Ovitrelle
choriogonadotropin alfa, Anovulation; Reproductive Techniques, Assisted; Infertility, Female
Date of authorisation: 02/02/2001, Revision: 22, Authorised, Last updated: 17/11/2022ovulation (the release of an egg from the ovaries) and the … ovulation (the release of an egg from the ovaries) and the … anovulatory (do not produce eggs) or oligo-ovulatory (rarely … -
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Referral: Topamax
topiramate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 25/06/2009, EC decision date: 01/10/2009, Last updated: 15/12/2009suicidal ideation, and metabolic acidosis (increased acid levels in … years for some medicines (e.g. different indications, contraindications … suicidal ideation, and metabolic acidosis (increased acid levels in … -
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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: 19, Authorised, Last updated: 30/05/2023any 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: 21, Authorised, Last updated: 30/05/2023any 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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Human medicine European public assessment report (EPAR): Ovaleap
follitropin alfa, Anovulation
Date of authorisation: 27/09/2013,
, Revision: 9, Authorised, Last updated: 03/10/2019
women who do not produce eggs and do not respond to treatment … stimulates the ovaries to produce eggs); women who are undergoing … to produce more than one egg at a time; women with severe … -
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Veterinary medicine European public assessment report (EPAR): Aivlosin
tylvalosin, Pheasants; Chicken; Turkeys; Pigs
Date of authorisation: 09/09/2004, Revision: 33, Authorised, Last updated: 29/03/2021chicks that hatched from eggs from flocks where the disease … for use in birds producing eggs for human consumption, and … withdrawal period for chicken eggs. As a consequence, the product … -
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Human medicine European public assessment report (EPAR): Libmeldy
atidarsagene autotemcel, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,, 
, Revision: 6, Authorised, Last updated: 17/04/2023
of infection), metabolic acidosis (imbalance in the body’s … of infection), metabolic acidosis (imbalance in the body’s … -
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Human medicine European public assessment report (EPAR): Nucala
Mepolizumab, Asthma
Date of authorisation: 01/12/2015, Revision: 18, Authorised, Last updated: 11/10/2022granulomatosis with polyangiitis (EGPA), a disease that causes vasculitis … aged 6 years and above when EGPA is relapsing-remitting or … with nasal polyps, HES or EGPA. The medicine is given by … -
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Human medicine European public assessment report (EPAR): Ocaliva
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , 
, Revision: 16, Authorised, Last updated: 02/05/2023
with supportive treatment (e.g. for itching) and dose adjustments … with supportive treatment (e.g. for itching) and dose adjustments … -
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Human medicine European public assessment report (EPAR): Eucreas
vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 14/11/2007, Revision: 23, Authorised, Last updated: 29/03/2023who could develop metabolic acidosis (build-up of acid in the … who could develop metabolic acidosis (build-up of acid in the … information on the risk of lactic acidosis. These patients form a large … -
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Human medicine European public assessment report (EPAR): Zomarist
vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 30/11/2008, Revision: 23, Authorised, Last updated: 20/03/2023who could develop metabolic acidosis (build-up of acid in the … who could develop metabolic acidosis (build-up of acid in the … -
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Human medicine European public assessment report (EPAR): ellaOne
ulipristal, Contraception, Postcoital
Date of authorisation: 15/05/2009, Revision: 28, Authorised, Last updated: 19/04/2023be ovulation (release of eggs) followed by the fertilisation … the fertilisation of the egg (fusion with a sperm) and … to receive the fertilised egg. The The substance responsible … -
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Human medicine European public assessment report (EPAR): Vectibix
panitumumab, Colorectal Neoplasms
Date of authorisation: 03/12/2007, Revision: 34, Authorised, Last updated: 06/07/2022and block a target called EGFR on certain cells, including … messages transmitted via EGFR that they need to grow and … cells does not depend on EGFR and they can continue to … -
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Veterinary medicine European public assessment report (EPAR): Panacur AquaSol
fenbendazole, Pigs; Chicken
Date of authorisation: 09/12/2011, Revision: 6, Authorised, Last updated: 26/04/2018against the worms and their eggs. What benefits of Panacur … Ascaris suum or Oesophagostomum eggs could be detected in the … number of Trichuris suis eggs was reduced by 90%. The effectiveness … -
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Human medicine European public assessment report (EPAR): Elonva
corifollitropin alfa, Reproductive Techniques, Assisted; Ovulation Induction; Investigative Techniques
Date of authorisation: 25/01/2010, Revision: 23, Authorised, Last updated: 05/04/2023development of more than one mature egg at a time in the ovaries … stimulates the growth of eggs in the ovaries and in men … development of more than one mature egg at a time in the ovaries … -
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Veterinary medicine European public assessment report (EPAR): Gumbohatch
live attenuated infectious bursal disease virus (IBDV), strain 1052, Chicken; Embryonated chicken eggs
Date of authorisation: 12/11/2019, Revision: 2, Authorised, Last updated: 05/03/2021antibodies. When a chick or chicken egg is given the vaccine, the … following vaccination of eggs or chicks. The start of protection … administration of a medicine before eggs may be used for human consumption …