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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Withdrawn application: Egranli
date of withdrawal: 04/11/2014, Initial authorisation, Last updated: 16/02/2015Egranli: Withdrawn application … Egranli, INN-balugrastim 30 … initial authorisation) Egranli balugrastim On 25 September … -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Withdrawn application: Egrifta
date of withdrawal: 21/06/2012, Initial authorisation, Last updated: 18/07/2012Egrifta: Withdrawn application … authorisation application for Egrifta (tesamorelin) On 21 June … marketing authorisation for Egrifta, for the treatment of excess … -
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Referral: Renitec
enalapril, Article 30 referrals
Status: European Commission final decision, opinion/position date: 19/09/2002, EC decision date: 21/05/2003, Last updated: 02/12/2003Commission final decision Overview Enalapril is a highly specific, competitive … the benefit/risk ratio of enalapril is considered to be favourable … Non-Proprietary Name (INN): enalapril: Background information an … -
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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, Withdrawn, Last updated: 30/06/2011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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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. International non-proprietary … in the vaccine, such as egg or chicken protein, ovalbumin … protein, ovalbumin (a protein in egg white), formaldehyde and … -
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Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001706-PIP01-14-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form
Decision date: 07/12/2018, Last updated: 20/02/2019, Compliance check: XKey facts Enalapril (maleate) Cardiovascular … paediatric investigation plan for enalapril (maleate) (EMEA-001706-PIP01-14-M02 … Enalapril (maleate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001241-PIP02-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 03/09/2014, Last updated: 29/09/2014, Compliance check: XKey facts Enalapril (maleate) Cardiovascular … paediatric investigation plan for enalapril (maleate) (EMEA-001241-PIP02-13-M01 … paediatric investigation plan for enalapril (maleate) (EMEA-001241-PIP02-13-M01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001516-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet for oral suspension, Orodispersible film
Decision date: 05/05/2014, Last updated: 06/06/2014, Compliance check: XKey facts Enalapril (maleate) Cardiovascular … the refusal of a waiver for enalapril (maleate) (EMEA-001516-PIP01-13 … the refusal of a waiver for enalapril (maleate) (EMEA-001516-PIP01-13 … -
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Orphan designation: 20% Intravenous fat emulsion consisting of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection for: Treatment of poisoning by local anaesthetics
Date of first decision: 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: 16/04/2019, Compliance check: Xstrain (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): Neparvis
sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016,
, Revision: 11, Authorised, Last updated: 24/02/2021
Neparvis was compared to enalapril, another medicine used for … 4,212) patients treated with enalapril. In general, patients were … Neparvis was more effective than enalapril. What are the risks associated … -
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Human medicine European public assessment report (EPAR): Entresto
sacubitril, valsartan, Heart Failure
Date of authorisation: 19/11/2015, Revision: 12, Authorised, Last updated: 07/12/2020Entresto was compared to enalapril, another medicine used for … 4,212) patients treated with enalapril. In general, patients were … Entresto was more effective than enalapril. What are the risks associated … -
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Referral: Renin-angiotensin-system (RAS)-acting agents
captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014Actavis captopril imidapril zofenopril candesartan delapril telmisartan aliskiren moexipril enalapril valsartan fosinopril irbesartan perindopril quinapril ramipril eprosartan olmesartan trandolapril losartan azilsartan lisinopril spirapril benazepril cilazapril telmisartan hydrochlorothiazide telmisartan telmisartan telmisartan telmisartan amlodipine telmisartan amlodipine telmisartan hydrochlorothiazide telmisartan hydrochlorothiazide telmisartan hydrochlorothiazide amlodipine valsartan hydrochlorothiazide amlodipine … -
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Human medicine European public assessment report (EPAR): Orgalutran (updated)
ganirelix, Reproductive Techniques, Assisted, Ovulation Induction
Date of authorisation: 16/05/2000, Revision: 21, Authorised, Last updated: 15/03/2021ovulation (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): Vizimpro
dacomitinib monohydrate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 02/04/2019,, Revision: 1, Authorised, Last updated: 22/02/2021
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): 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): Elonva
corifollitropin alfa, Reproductive Techniques, Assisted, Ovulation Induction
Date of authorisation: 25/01/2010, Revision: 17, Authorised, Last updated: 26/02/2021development 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): Tarceva
erlotinib, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms
Date of authorisation: 19/09/2005, Revision: 29, Authorised, Last updated: 24/04/2019epidermal 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: 23, 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): Tagrisso
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,, 
, Revision: 12, Authorised, Last updated: 16/10/2020
gene for a protein called EGFR. If a patient has mutations … 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): Ovitrelle
choriogonadotropin alfa, Anovulation, Reproductive Techniques, Assisted, Infertility, Female
Date of authorisation: 02/02/2001, Revision: 20, Authorised, Last updated: 18/01/2021ovulation (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): Puregon
follitropin beta, Infertility, Hypogonadism
Date of authorisation: 02/05/1996, Revision: 30, Authorised, Last updated: 11/02/2021anovulatory (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 …