12848 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, Revision: 7, Withdrawn, Last updated: 29/07/2021
as Pemetrexed Hospira UK Limited) Carcinoma, Non-Small-Cell … as Pemetrexed Hospira UK Limited) … public Pemetrexed Hospira UK Limited pemetrexed This is a summary … -
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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Date of authorisation: 28/08/2015,, Revision: 8, Withdrawn, Last updated: 15/10/2019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 designation: 15/10/2014, Positive, Last updated: 12/11/2014Cultured allogeneic corneal limbal stem cells Overview On 15 … cultured allogeneic corneal limbal stem cells for the treatment … cells for the treatment of limbal stem cell deficiency. What … -
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Herbal medicinal product: Tiliae tomentosae flos
Tilia tomentosa Moench, Silver lime flower, F: Assessment finalised, Last updated: 09/07/2012Tiliae tomentosae flosSilver lime flowerTilia tomentosa Moench … tomentosa Moench, flos (silver lime) EMA/HMPC/160869/2010 22/03/2010 … 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 designation: 23/02/2011, Positive, Last updated: 04/03/2011idiotype coupled to keyhole limpet hemocyanin Overview On 23 … idiotype coupled to keyhole limpet hemocyanin for the treatment … transferred to Biovest Europe Limited, United Kingdom, in September … -
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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 OncologyP/0180/2012EMEA-001274-PIP01-12 … idiotype coupled to keyhole limpet haemocyanin (EMEA-001274-PIP01-12 … idiotype coupled to keyhole limpet haemocyanin (EMEA-001274-PIP01-12) 7 … -
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Herbal medicinal product: Tiliae flos
Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne, Lime flower, F: Assessment finalised, Last updated: 15/02/2023Tilia x vulgaris Heyne, flos (lime flower) - First version EMA/HMPC/160868/2010 … Scop., Tilia x vulgaris Heyne Lime flower … -
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Orphan designation: Autologous tumour-derived immunoglobulin idiotype coupled to keyhole limpet hemocyanin for: Treatment of follicular lymphoma
Date of designation: 28/08/2006, Positive, Last updated: 14/06/2012idiotype coupled to keyhole limpet hemocyanin Overview On 28 … idiotype coupled to keyhole limpet haemocyanin for the treatment … subsequently to Biovest Europe Limited, United Kingdom, in September … -
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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 designation: 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 Overview … 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 the treatment … -
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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 OncologyP/0259/2015EMEA-001810-PIP01-15 … 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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News: European Medicines Agency revises MUMS / limited-market policy
CVMP, Last updated: 18/06/2013Medicines Agency revises MUMS / limited-market policy … minor-use-minor-species (MUMS) / limited-market policy (MUMS policy) for … applications for products for limited markets is intended to stimulate … -
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Classifications as minor-use-minor-species and limited-market according to former EMA policy
Last updated: 06/12/2021minor-use-minor-species and limited-market according to former EMA polic … minor-use-minor-species and limited-market according to former EMA polic …
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Maximum residue limits (MRL)
Last updated: 14/02/2023Maximum residue limits (MRL … found under 'Maximum residue limits'. maximum residue limit (MRL) is the maximum allowed … establishment of residue limits of pharmacologically active …
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National expert: Jobst Limberg, Federal Institute For Drugs And Medical Devices (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 20.28 KB | PDF
Jobst Limberg … Jobst Limberg … Vitae PERSONAL INFORMATION Jobst Limberg WORK EXPERIENCE May 2011 … -
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Maximum residue limit opinions
Last updated: 01/07/2022Maximum residue limit opinions … found under 'Maximum residue limits'. maximum residue limit (MRL) evaluations. The MRL … establishment of maximum residue limits : Bambermycin (EXTN/0002 …
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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: 23/07/2021product as intended for a limited market and eligibility for … 2019/6 (Applications for limited markets … product as intended for a limited market and eligibility for …
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Veterinary limited markets
Last updated: 04/02/2016Veterinary limited markets … Veterinary limited markets …
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Veterinary limited markets
Last updated: 27/04/2010Veterinary limited markets … Veterinary limited markets …
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National expert: Ulla Wändel Liminga, Medical Products Agency (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 20.71 KB | PDF
Ulla Wändel Liminga … Ulla Wändel Liminga … Vitae PERSONAL INFORMATION Ulla Wandel Liminga WORK EXPERIENCE January … -
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Maximum residue limits
Last updated: 31/12/2009Maximum residue limits … review of Maximum Residue Limits (MRLs) PDF icon application/pdf … Governance Maximum residue limit …
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Veterinary limited markets
Last updated: 02/09/2021Veterinary limited markets … Veterinary limited markets … product as intended for a limited market according to Article …
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Maximum residue limit assessment reports
Last updated: 12/03/2010Maximum residue limit assessment reports … found under 'Maximum residue limits'. maximum residue limits for The substance responsible …
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Maximum Residue Limits Q&A: Introduction
Last updated: 31/12/2009Maximum Residue Limits Q&A: Introduction … Union ”: Maximum residue limits guidelines (MRL …
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Pending EC decisions on maximum residue limits
Last updated: 12/03/2010decisions on maximum residue limits … opinion on maximum residue limits for active substances contained …
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Direct healthcare professional communication (DHPC): Visudyne (verteporfin): Information on the continuing supply limitation until end of 2023
Active substance: verteporfin, DHPC type: Medicine shortage, Last updated: 12/08/2022on the continuing supply limitation until end of 2023 Myopia … on the continuing supply limitation until end of 2023 12/08/2022 … on the continuing supply limitation until end of 2023 Dear …