4862 results
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Equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract - Scientific guideline
Last updated: 07/11/2018therapeutic equivalence for locally applied locally acting products in the gastrointestinal … therapeutic equivalence for locally applied locally acting products in the gastrointestinal … CLINICAL REQUIREMENTS FOR LOCALLY APPLIED LOCALLY ACTING PRODUCTS CONTAINING …
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Non-clinical local tolerance testing of medicinal products - Scientific guideline
Last updated: 27/11/2015Non-clinical local tolerance testing of medicinal … Non-clinical local tolerance testing of medicinal … Guideline on non-clinical local tolerance testing of medicinal …
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Local tolerance of intramammary preparations in cows - Scientific guideline
Last updated: 01/11/1992Local tolerance of intramammary … Local tolerance of intramammary … 7AE21a ■ LOCAL TOLERANCE OF INTRAMAMMARY PREPARATIONS …
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Press release: European Medicines Agency recommends approval of a locally targeted treatment for ulcerative colitis and Crohn's disease
CHMP, Last updated: 21/03/2014recommends approval of a locally targeted treatment for ulcerative … recommends approval of a locally targeted treatment for ulcerative … recommends approval of a locally targeted treatment for … -
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Human medicine European public assessment report (EPAR): Firmagon
degarelix, Prostatic Neoplasms
Date of authorisation: 17/02/2009, Revision: 19, Authorised, Last updated: 04/10/2022radiotherapy to treat high-risk localised or locally advanced hormone-dependent … prostate cancer. ‘High-risk localised’ means that the cancer is … nearby tissues and become ‘locally advanced’. Firmagon contains … -
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Human medicine European public assessment report (EPAR): Exparel liposomal
bupivacaine, Acute Pain
Date of authorisation: 16/11/2020, Revision: 1, Authorised, Last updated: 14/11/2022Exparel liposomal is a local anaesthetic that is used … aged 6 years or older for local pain relief by injecting … pain scores when used for local pain relief around small … -
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Human medicine European public assessment report (EPAR): Taxotere
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 27/11/1995, Revision: 50, Authorised, Last updated: 24/03/2023patients whose cancer is locally advanced (a cancer that has … patients whose cancer is locally advanced (a cancer that has … -
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Human medicine European public assessment report (EPAR): Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 20/04/2007, Revision: 30, Withdrawn, Last updated: 20/05/2022treatment of patients with locally advanced or metastatic breast … treatment of patients with locally advanced or metastatic breast … treatment of patients with locally advanced or metastatic breast … -
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Human medicine European public assessment report (EPAR): Erivedge
vismodegib, Carcinoma, Basal Cell
Date of authorisation: 12/07/2013,
Date of refusal: 26/04/2013, Revision: 15, Authorised, Last updated: 20/03/2023causing symptoms, or when it is locally advanced (has started to … with either metastatic or locally advanced basal-cell carcinoma … out of 63) of patients with locally advanced disease responded … -
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Human medicine European public assessment report (EPAR): Docetaxel Teva
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 26/01/2010,
, Revision: 18, Withdrawn, Last updated: 14/12/2021
treatment of patients with locally advanced or metastatic breast … treatment of patients with locally advanced or metastatic breast … treatment of patients with locally advanced or metastatic breast … -
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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
carcinoma when the cancer is locally advanced (has spread nearby … BCC) when the cancer is locally advanced or metastatic. It … NSCLC) when the cancer is locally advanced and cannot be treated … -
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Human medicine European public assessment report (EPAR): Docefrez
docetaxel, Stomach Neoplasms; Adenoma; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Prostatic Neoplasms
Date of authorisation: 10/05/2010,, Revision: 1, Withdrawn, Last updated: 14/06/2012
treatment of patients with locally advanced or metastatic breast … treatment of patients with locally advanced or metastatic breast … treatment of patients with locally advanced or metastatic breast … -
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Human medicine European public assessment report (EPAR): Docetaxel Accord
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 16, Authorised, Last updated: 20/03/2023
patients whose cancer is locally advanced (a cancer that has … -
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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: 05/07/2022non-small-cell lung cancer that is locally advanced or metastatic (when … 1,217 adult patients with locally advanced or metastatic non-small-cell … involving 1,466 patients with locally advanced or metastatic non-small-cell … -
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Human medicine European public assessment report (EPAR): Taxespira (previously Docetaxel Hospira UK Limited )
docetaxel trihydrate, Stomach Neoplasms; Prostatic Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 28/08/2015,, Revision: 8, Withdrawn, Last updated: 15/10/2019
treatment of patients with locally advanced or metastatic breast … treatment of patients with locally advanced or metastatic breast … treatment of patients with locally advanced or metastatic breast … -
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Human medicine European public assessment report (EPAR): Imfinzi
durvalumab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 21/09/2018,, Revision: 16, Authorised, Last updated: 02/05/2023
lung cancer (NSCLC) that is locally advanced (meaning it has … lung cancer (NSCLC) that is locally advanced (meaning it has … it or for up to 1 year for locally advanced NSCLC. Imfinzi … -
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Human medicine European public assessment report (EPAR): Fortacin
lidocaine, prilocaine, Sexual Dysfunction, Physiological
Date of authorisation: 15/11/2013, Revision: 11, Authorised, Last updated: 20/09/2022lidocaine and prilocaine, are local anaesthetics that temporarily … hypersensitive (allergic) to other local anaesthetics which are chemically … active ingredients (amide-type local anaesthetics). Fortacin must … -
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Human medicine European public assessment report (EPAR): Perjeta
pertuzumab, Breast Neoplasms
Date of authorisation: 04/03/2013, Revision: 22, Authorised, Last updated: 09/12/2021cancer that has come back locally after treatment and cannot … medicines); treatment of locally advanced, inflammatory or … HER2-positive metastatic or locally advanced breast cancer. Recommendations … -
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Human medicine European public assessment report (EPAR): Camcevi (updated)
leuprorelin mesilate, Prostatic Neoplasms
Date of authorisation: 24/05/2022, Revision: 1, Authorised, Last updated: 12/05/2023with radiotherapy to treat locally advanced hormone-dependent … prostate cancer and high-risk localised prostate cancer (this means … nearby tissues and become ‘locally advanced’). Camcevi is … -
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Human medicine European public assessment report (EPAR): Docetaxel Kabi
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 14, Authorised, Last updated: 28/10/2020
patients whose cancer is locally advanced (a cancer that has … -
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Human medicine European public assessment report (EPAR): Odomzo
sonidegib diphosphate, Carcinoma, Basal Cell
Date of authorisation: 14/08/2015, Revision: 10, Authorised, Last updated: 26/04/2021of skin cancer) which is locally advanced (has started to … carcinoma which was either locally advanced or metastatic (spread … least 30%. Of those with locally advanced basal cell carcinoma … -
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Human medicine European public assessment report (EPAR): Trodelvy
Sacituzumab govitecan, Breast Neoplasms; Triple Negative Breast Neoplasms
Date of authorisation: 22/11/2021,, Revision: 2, Authorised, Last updated: 22/02/2023
areas outside the breast (locally advanced) or to other parts … patients with metastatic or locally advanced triple-negative … expected in patients with locally advanced cancer that cannot … -
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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: 07/03/2023treatment of adult patients with locally advanced or metastatic urothelial … -
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Human medicine European public assessment report (EPAR): Pemetrexed Lilly
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 14/09/2015,, Revision: 7, Withdrawn, Last updated: 26/11/2021
treatment of patients with locally advanced or metastatic non-small … maintenance treatment of locally advanced or metastatic non-small … treatment of patients with locally advanced or metastatic non … -
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Human medicine European public assessment report (EPAR): Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited)
pemetrexed ditromethamine, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 24/04/2017,, Revision: 7, Withdrawn, Last updated: 29/07/2021
treatment of patients with locally advanced or metastatic non-small … maintenance treatment of locally advanced or metastatic non-small … treatment of patients with locally advanced or metastatic non-small …