174 results
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Opinion/decision on a Paediatric investigation plan (PIP): Insulin human (NTRA-2112)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002116-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral solution
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: XKey facts Insulin human (NTRA-2112) Gastroentology-HepatologyP/0079/2018EMEA-002116-PIP01-17 … waiver for insulin human (NTRA-2112) (EMEA-002116-PIP01-17 … waiver for insulin human (NTRA-2112) (EMEA-002116-PIP01-17 … -
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Orphan designation: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide for: Treatment of cystic fibrosis
Date of designation: 29/05/2019, Withdrawn, Last updated: 30/07/2021N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide … Consulting S.A.R.L., France, for N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide … opinion on orphan designation N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3- phenylisoxazole-5-carboxamide … -
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Opinion/decision on a Paediatric investigation plan (PIP): N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl) cyclobutyl)-3-phenylisoxazole-5-
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002398-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral dosage form, Capsule, hard
Decision date: 17/05/2019, Last updated: 12/10/2020, Compliance check: XActive substance N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl … N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl … -
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Human medicine European public assessment report (EPAR): Rozlytrek
Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020,
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, Revision: 5, Authorised, Last updated: 29/11/2022
NTRK … tyrosine receptor kinase (NTRK) gene fusion, • who have … have not received a prior NTRK inhibitor • who have no … -
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Human medicine European public assessment report (EPAR): Vitrakvi
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 7, Authorised, Last updated: 21/09/2022
treating solid tumours with NTRK gene fusion NTRK gene fusion is a rare genetic … Vitrakvi work? Tumours with NTRK gene fusion produce an abnormal … patients with solid tumours with NTRK gene fusion showed that Vitrakvi … -
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Orphan designation: Larotrectinib for: Treatment of salivary gland cancer
Date of designation: 21/03/2018, Withdrawn, Last updated: 24/10/2019mutations (changes) called NTRK -fusion mutations which result … treatment of solid tumors with NTRK-fusion proteins. In accordance with … -
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Orphan designation: Larotrectinib for: Treatment of glioma
Date of designation: 19/11/2018, Withdrawn, Last updated: 24/10/2019NTRK … -
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Orphan designation: Larotrectinib for: Treatment of papillary thyroid cancer
Date of designation: 19/11/2018, Withdrawn, Last updated: 24/10/2019NTRK … -
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Press release: First ‘histology-independent’ treatment for solid tumours with a specific gene mutation
CHMP, Last updated: 26/07/2019Tyrosine Receptor Kinase (NTRK) gene fusion. Treatment with … tumour. This occurs when NTRK genes that encode specific … gene. This mutation, called NTRK gene fusion, leads to the … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2019
CHMP, Last updated: 26/07/2019tyrosine receptor kinase (NTRK) gene fusion NTRK gene fusions occur very frequently … -
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National expert: Marcel Maliepaard, Medicines Evaluation Board (updated)
- Declaration of interests - 80.01 KB | PDF
- Curriculum Vitae - 28.16 KB | PDF
National Trial Register number: NTR2964, funded by the Medicines Evaluation … -
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National expert: Nuno Sousa, National Authority Of Medicines And Health Products (updated)
- Declaration of interests - 85.13 KB | PDF
- Curriculum Vitae - 16.82 KB | PDF
Larotrectinib Tumor agnostic NTRK mutation neoplasms 02/2015-07/2021 … -
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Human medicine European public assessment report (EPAR): Symtuza (updated)
darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/09/2017, Revision: 17, Authorised, Last updated: 21/03/2023 -
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Human medicine European public assessment report (EPAR): SomaKit TOC (updated)
edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016,
, Revision: 14, Authorised, Last updated: 07/03/2023
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Human medicine European public assessment report (EPAR): Odefsey
emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/06/2016, Revision: 20, Authorised, Last updated: 20/02/2023 -
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Human medicine European public assessment report (EPAR): Eviplera
emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 27/11/2011, Revision: 25, Authorised, Last updated: 13/12/2022 -
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Human medicine European public assessment report (EPAR): Descovy
emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/04/2016, Revision: 20, Authorised, Last updated: 17/02/2023 -
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Human medicine European public assessment report (EPAR): Edurant
rilpivirine hydrochloride, HIV Infections
Date of authorisation: 28/11/2011, Revision: 20, Authorised, Last updated: 28/10/2022 -
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Human medicine European public assessment report (EPAR): Biktarvy
bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections
Date of authorisation: 21/06/2018, Revision: 15, Authorised, Last updated: 23/01/2023 -
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Human medicine European public assessment report (EPAR): Tasigna
nilotinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 19/11/2007, Revision: 42, Authorised, Last updated: 26/10/2022 -
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Human medicine European public assessment report (EPAR): Cabometyx
cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016,
, Revision: 15, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Genvoya
elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 19/11/2015, Revision: 27, Authorised, Last updated: 28/11/2022 -
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Human medicine European public assessment report (EPAR): Intelence
Etravirine, HIV Infections
Date of authorisation: 28/08/2008, Revision: 30, Authorised, Last updated: 28/11/2022 -
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Human medicine European public assessment report (EPAR): Viread
tenofovir disoproxil fumarate, Hepatitis B, Chronic; HIV Infections
Date of authorisation: 04/02/2002, Revision: 58, Authorised, Last updated: 04/01/2023 -
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Human medicine European public assessment report (EPAR): Tybost
cobicistat, HIV Infections
Date of authorisation: 19/09/2013, Revision: 15, Authorised, Last updated: 14/02/2023