10953 results
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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: 6, Authorised, Last updated: 20/08/2019
as Pemetrexed Hospira UK Limited) Carcinoma, Non-Small-Cell … as Pemetrexed Hospira UK Limited) … different indication, such as a limited indication that will allow … -
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Herbal medicinal product: Tiliae flos
Tilia cordata Miller, Lime flower, F: Assessment finalised, Last updated: 10/07/2012flos English common name Lime flower Botanical name Tilia … mixtures, flos; Tiliae flos; Lime flower BG (bălgarski … φιλλύρας EN (English): Lime flower ES (espanol): Tilo … -
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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Date of authorisation: 28/08/2015,, Revision: 8, Withdrawn, Last updated: 15/10/2019
previously Docetaxel Hospira UK Limited ) Stomach Neoplasms Prostatic … previously Docetaxel Hospira UK Limited … different indication, such as a limited indication that will allow … -
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Orphan designation: Cultured allogeneic corneal limbal stem cells for: Treatment of limbal stem cell deficiency
Date of first decision: 15/10/2014, Positive, Last updated: 12/11/2014cultured allogeneic corneal limbal stem cells for the treatment … cells for the treatment of limbal stem cell deficiency. Expand … Collapse section What is limbal stem cell deficiency … -
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Herbal medicinal product: Tiliae tomentosae flos
Tilia tomentosa Moench, Silver lime flower, F: Assessment finalised, Last updated: 09/07/2012English common name Silver lime flower Botanical name Tilia … tomentosa Moench Silver lime flower … -
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Orphan designation: Autologous tumour-derived immunoglobulin idiotype coupled to keyhole limpet hemocyanin for: Treatment of mantle cell lymphoma
Date of first decision: 23/02/2011, Positive, Last updated: 04/03/2011idiotype coupled to keyhole limpet hemocyanin for the treatment … transferred to Biovest Europe Limited, United Kingdom, in September … attached to a carrier, 'keyhole limpet haemocyanin' (a protein prepared … -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous tumour-derived immunoglobulin idiotype coupled to keyhole limpet hemocyanin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001274-PIP01-12, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 20/08/2012, Last updated: 17/09/2012, Compliance check: Xidiotype coupled to keyhole limpet hemocyanin Therapeutic area … idiotype coupled to keyhole limpet haemocyanin (EMEA-001274-PIP01-12) 7 … idiotype coupled to keyhole limpet haemocyanin (EMEA-001274-PIP01-12 … -
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Orphan designation: Autologous tumour-derived immunoglobulin idiotype coupled to keyhole limpet hemocyanin for: Treatment of follicular lymphoma
Date of first decision: 28/08/2006, Positive, Last updated: 14/06/2012idiotype coupled to keyhole limpet haemocyanin for the treatment … subsequently to Biovest Europe Limited, United Kingdom, in September … idiotype coupled to keyhole limpet haemocyanin might be of potential … -
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Orphan designation: L-cysteine, L-leucyl-L-alpha-glutamyl-L-alpha-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-alpha-aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-complex with keyhole limpet haemocyanin for: Treatment of glioma
Date of first decision: 27/10/2011, Withdrawn, Last updated: 04/12/2020L-leucyl-L-alpha-glutamyl-L-alpha-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-alpha-aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-complex with keyhole limpet haemocyanin (also known as … carrier, called 'keyhole limpet haemocyanin' (a protein prepared … -
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Opinion/decision on a Paediatric investigation plan (PIP): L-Cysteine, L-leucyl-L-α-glutamyl-L-α-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-α -aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-, complex with keyhole limpet haemocyanin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001810-PIP01-15, Route(s) of administration: Intradermal use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 30/10/2015, Last updated: 22/12/2015, Compliance check: Xaspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-, complex with keyhole limpet haemocyanin Therapeutic area … aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-, complex with keyhole limpet haemocyanin (EMEA-001810-PIP01-15 … -
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Classifications as minor-use-minor-species and limited-market
Last updated: 08/07/2020minor-use-minor-species and limited-market … minor-use-minor-species and limited-market …
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News: European Medicines Agency revises MUMS / limited-market policy
CVMP, Last updated: 18/06/2013Medicines Agency revises MUMS / limited-market policy … Medicines Agency revises MUMS / limited-market policy … Medicines Agency amends MUMS limited market policy 13 June … -
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Maximum residue limits (MRL) (updated)
Last updated: 01/03/2021Maximum residue limits (MRL … Maximum residue limits (MRL … analytical method: Limit of quantification (LOQ …
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National expert: Jobst Limberg, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 79.77 KB | PDF
- Curriculum Vitae - 19.51 KB | PDF
Vitae PERSONAL INFORMATION Jobst Limberg WORK EXPERIENCE May 2011 … validation, statistics Publications Limberg, J.; Harrison, D.; Hocking … Sci., 79 (11) p 968, 1990Limberg, J; LeBel, M; Derendorf … -
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Maximum residue limit opinions
Last updated: 07/07/2016Maximum residue limit opinions … Maximum residue limit opinions … establishment of maximum residue limits Procedure no: EMEA/V/MRL/003141/EXTN/0004 …
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Maximum residue limits
Last updated: 31/12/2009Maximum residue limits … Maximum residue limits … review of Maximum Residue Limits (MRLs) 30 Churchill …
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National expert: Ulla Wändel Liminga, Medical Products Agency (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 20.4 KB | PDF
Vitae PERSONAL INFORMATION Ulla Wandel Liminga WORK EXPERIENCE January … Stahl E, Brady J.T., Wändel-Liminga U, Corriol-Rohou S, Forster … P.E., Robertson S.M., Silva-Lima B, Malik R.E., Chibout S.D … -
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Classification of a product as intended for a limited market and eligibility for authorisation under Article 23 of Regulation (EU) 2019/6 (Applications for limited markets)
Last updated: 25/02/2021product as intended for a limited market and eligibility for … 2019/6 (Applications for limited markets … applications for veterinary limited markets under the Veterinary …
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Minor use / minor species and limited markets (updated)
Last updated: 25/02/2021Minor use / minor species and limited markets … Minor use / minor species and limited markets …
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Maximum residue limit assessment reports
Last updated: 12/03/2010Maximum residue limit assessment reports … Maximum residue limit assessment reports …
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Maximum Residue Limits Q&A: Introduction
Last updated: 31/12/2009Maximum Residue Limits Q&A: Introduction … Maximum Residue Limits Q&A: Introduction …
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Pending EC decisions on maximum residue limits
Last updated: 12/03/2010decisions on maximum residue limits … decisions on maximum residue limits …
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Availability of veterinary medicinal products - extrapolation of maximum residue limits
Last updated: 18/06/2018extrapolation of maximum residue limits … extrapolation of maximum residue limits …
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Press release: Wyeth Europa Limited withdraws its marketing authorisation application for Brilence
Last updated: 28/05/2010Wyeth Europa Limited withdraws its marketing authorisation … Wyeth Europa Limited withdraws its marketing authorisation … Press release Wyeth Europa Limited withdraws its marketing authorisation … -
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Press release: La Jolla Limited withdraws its marketing authorisation application for Riquent
Last updated: 13/10/2006La Jolla Limited withdraws its marketing authorisation … La Jolla Limited withdraws its marketing authorisation … PRESS RELEASE La Jolla Limited withdraws its marketing authorisation …