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Opinion/decision on a Paediatric investigation plan (PIP): EGFR-cMET bispecific antibody
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002573-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 16/08/2019, Last updated: 20/11/2019, Compliance check: XKey facts EGFR-cMET bispecific antibody OncologyP/0289/2019EMEA-002573-PIP01-19 … product specific waiver for EGFR-cMET bispecific antibody (EMEA-002573-PIP01-19 … EGFR-cMET bispecific antibody … -
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Withdrawn application: Egranli
date of withdrawal: 04/11/2014, Initial authorisation, Last updated: 16/02/2015Egranli: Withdrawn application … Egranli, INN-balugrastim 30 … initial authorisation) Egranli balugrastim On 25 September … -
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Withdrawn application: Egrifta
date of withdrawal: 21/06/2012, Initial authorisation, Last updated: 18/07/2012Egrifta: Withdrawn application … authorisation application for Egrifta (tesamorelin) On 21 June … marketing authorisation for Egrifta, for the treatment of excess … -
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Human medicine European public assessment report (EPAR): Arepanrix
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs., Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 23/03/2010,
, Revision: 1, Withdrawn, Last updated: 25/10/2011
strain (X-179A)*propagated in eggs.pandemic influenza vaccine (H1N1)v … in the vaccine, such as egg or chicken protein, ovalbumin … protein, ovalbumin (a protein in egg white), formaldehyde and … -
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Human medicine European public assessment report (EPAR): Humenza
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs., Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 08/06/2010,, Withdrawn, Last updated: 30/06/2011
strain (X-179A)*propagated in eggs.pandemic influenza vaccine (H1N1 … as ovalbumin (a protein in egg white egg or chicken proteins, neomycin … strain (X-179A)*propagated in eggs. … -
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Orphan designation: Refusal of orphan designation for the treatment of poisoning by local anaesthetics
Date of refusal of designation: 03/04/2017, Negative, Last updated: 15/05/2017of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25 … of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25 … of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25 … -
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Human medicine European public assessment report (EPAR): Daronrix
Whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)* produced in eggs, Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 21/03/2007,
, Withdrawn, Last updated: 02/07/2013
A/Vietnam/1194/2004 (H5N1)* produced in eggspandemic influenza vaccine (whole … in the vaccine, such as eggs, chicken protein or gentamicin … A/Vietnam/1194/2004 (H5N1)* produced in eggs … -
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Opinion/decision on a Paediatric investigation plan (PIP): Humenza, Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000669-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for injection
Decision date: 04/01/2019, Last updated: 21/09/2021, Compliance check: V, 26/04/2019strain (X-179A)*propagated in eggs. … -
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Opinion/decision on a Paediatric investigation plan (PIP): Arepanrix, Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted), containing antigen equivalent to Influenza A/California/7/2009
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000687-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for emulsion for injection
Decision date: 09/08/2010, Last updated: 07/10/2010, Compliance check: V, 12/12/2014strain (X-179A)*propagated in eggs. … -
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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): Iressa
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 24/06/2009, Revision: 14, Authorised, Last updated: 05/03/2021epidermal-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): 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): Rybrevant
amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021,, , Authorised, Last updated: 04/02/2022
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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Human medicine European public assessment report (EPAR): Gefitinib Mylan (updated)
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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Human medicine European public assessment report (EPAR): Tagrisso
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,
, Revision: 15, Authorised, Last updated: 07/04/2022
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): 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 … -
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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: 24, Authorised, Last updated: 11/02/2020over) 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): Elonva
corifollitropin alfa, Reproductive Techniques, Assisted; Ovulation Induction; Investigative Techniques
Date of authorisation: 25/01/2010, Revision: 21, Authorised, Last updated: 08/11/2021development of more than one mature egg at a time in the ovaries … ovaries from releasing their eggs too early. Seven days after … Finally, as soon as three eggs are close to maturation … -
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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: 21, Authorised, Last updated: 09/11/2021ovulation (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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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): 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): 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): 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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Human medicine European public assessment report (EPAR): Nucala
Mepolizumab, Asthma
Date of authorisation: 01/12/2015, Revision: 17, Authorised, Last updated: 11/05/2022granulomatosis 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): Rekovelle
follitropin delta, Anovulation
Date of authorisation: 12/12/2016, Revision: 5, Authorised, Last updated: 28/03/2022ovaries to produce several eggs at the time, which can then … continued until sufficient eggs have developed. The starting … stimulating the production of eggs in the ovaries. Giving extra …