14770 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, Revision: 7, Withdrawn, Last updated: 29/07/2021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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Opinion/decision on a Paediatric investigation plan (PIP): Human papilloma virus type 16 E6 071-095, human papilloma virus type 16 E7 064-098, human papilloma virus type 16 E6 055-080, human papilloma virus type 16 E6 001-032, human papilloma virus type 16 E6 091-122
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001055-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for suspension for injection
Decision date: 04/03/2011, Last updated: 08/04/2011, Compliance check: Xpapilloma virus type 16 E6 071-095 human papilloma virus type … papilloma virus type 16 E7 064-098 human papilloma virus type … papilloma virus type 16 E6 091-122 OncologyP/61/2011EMEA-001055-PIP01-10 … -
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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Date of authorisation: 28/08/2015,, Revision: 8, Withdrawn, Last updated: 15/10/2019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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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 … EMA/HMPC/346780/2011Adopted 09/07/2012 09/07/2012 Document details Final list … EMA/HMPC/346776/2011Adopted 09/07/2012 … -
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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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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 … WC500132547_en.pdf Adopted 17/09/2012 17 … -
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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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Human medicine European public assessment report (EPAR): Vumerity
Diroximel fumarate (BIIB098), Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 15/11/2021, Revision: 3, Authorised, Last updated: 23/11/2022vumerity_-_smop_en.pdf Adopted 17/09/2021 EMA/CHMP/500803/2021 … fumarate Diroximel fumarate (BIIB098 … -
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Orphan designation: Oxygen, sodium chloride solution 0.9% for: Treatment of amyotrophic lateral sclerosis (new)
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023sodium chloride solution 0.9% Intended use Treatment of … Sponsor Dlrc Pharma Services Limited Chesterfield House Clonmannon … sodium chloride solution 0.9 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Diroximel fumarate (BIIB098)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-002685-PIP02-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Gastro-resistant capsule, hard
Decision date: 09/09/2020, Last updated: 06/07/2021, Compliance check: Xfacts Diroximel fumarate (BIIB098) NeurologyP/0381/2020EMEA-002685-PIP02-19 … for diroximel fumarate (BIIB098) (EMEA-002685-PIP02-19) PDF … for diroximel fumarate (BIIB098) (EMEA-002685-PIP02-19) in … -
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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: 06/04/2022Tilia 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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Opinion/decision on a Paediatric investigation plan (PIP): Human papilloma virus type 16 E6 071-095, human papilloma virus type 16 E6 001-032, human papilloma virus type 16 E6 055-080, human papilloma virus type 16 E6 091-122, Human Papilloma Virus Type 16 E6 109-140, Human Papilloma Virus Type 16 E6 019-050, Human Papilloma Virus Type 16 E6 041-065, Human Papilloma Virus Type 16 E6 085-109, Human Papilloma Virus Type 16 E6 127-158, human papilloma virus type 16 E7 064-098, Human Papilloma Virus Type 16 E7 022-056, Human Papilloma Virus Type 16 E7 001-035
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001055-PIP02-21, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 09/07/2021, Last updated: 22/07/2022, Compliance check: Xpapilloma virus type 16 E6 071-095 human papilloma virus type … papilloma virus type 16 E6 091-122 Human Papilloma Virus Type … papilloma virus type 16 E7 064-098 Human Papilloma Virus Type … -
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Veterinary medicine European public assessment report (EPAR): Respiporc FLUpan H1N1
Influenza A virus/human strain: A/Jena/VI5258/2009 (H1N1)pdm09, inactivated, Pigs
Date of authorisation: 17/05/2017, Revision: 6, Authorised, Last updated: 21/03/2022exceed the maximum residue limit. More information can be found … found under 'Maximum residue limits'. withdrawal period is the … exceed the maximum residue limit. More information can be found … -
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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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Opinion/decision on a Paediatric investigation plan (PIP): Omega-3-acid (85% ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of 0.9-1.5), simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Omega-3-acid (85% ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio of 0.9-1.5), simvastatin, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 01/12/2008, Last updated: 29/01/2009, Compliance check: Xacid (DHA) in a ratio of 0.9-1.5), simvastatin Cardiovascular … acid (DHA) in a ratio of 0.9-1.5) simvastatin Cardiovascular … acid (DHA) in a ratio of 0.9-1.5), simvastatin Capsule, soft … -
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Opinion/decision on a Paediatric investigation plan (PIP): 1,4-dihydro-1-[(2R)-2-(2-methoxyphenyl)-2-[(tetrahydro-2H-pyran-4-yl)oxy]ethyl]-α,α,5-trimethyl-6-(2-oxazolyl)-2,4-dioxo-thieno[2,3-d]pyrimidine-3(2H)-acetic acid (GS-0976)
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-002109-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 31/01/2018, Last updated: 18/04/2018, Compliance check: X1,4-dihydro-1-[(2R)-2-(2-methoxyphenyl)-2-[(tetrahydro-2H-pyran-4-yl)oxy]ethyl]-α,α,5-trimethyl-6-(2-oxazolyl)-2,4-dioxo-thieno[2,3-d]pyrimidine-3(2H)-acetic acid (GS-0976) Gastroentology-HepatologyP/0023/2018EMEA-002109-PIP01-16 … 1,4-dihydro-1-[(2R)-2-(2-methoxyphenyl)-2-[(tetrahydro-2H-pyran-4- yl)oxy]ethyl]-α,α,5-trimethyl-6-(2-oxazolyl)-2,4-dioxo-thieno[2,3-d]pyrimidine-3(2H)-acetic acid (GS- 0976) (EMEA-002109-PIP01-16) in … -
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Human medicine European public assessment report (EPAR): Fluenz
Reassortant influenza virus (live attenuated) of the following strains:A/California/7/2009 (H1N1)pdm09 like strain, A/Victoria/361/2011 (H3N2) like strain, B/Massachusetts/2/2012 like strain, Influenza, Human; Immunization
Date of authorisation: 27/01/2011,
, Revision: 4, Withdrawn, Last updated: 03/12/2014
strains:A/California/7/2009 (H1N1)pdm09 like strain, A/Victoria/361/2011 … A/California/7/2009 (H1N1)pdm09-like strain; A/Victoria/361/2011 … strains:A/California/7/2009 (H1N1)pdm09 like strain, A/Victoria/361/2011 … -
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Human medicine European public assessment report (EPAR): Fluad Tetra (updated)
A/Victoria/2570/2019 (H1N1)pdm09 like strain (A/Victoria/2570/2019 IVR‐215) A/Darwin/9/2021 (H3N2) like strain (A/Darwin/6/2021 IVR-227) B/Austria/1359417/2021 like strain (B/Austria/1359417/2021 BVR-26) B/Phuket/3073/2013 like strain (B/Phuket/3073/2013 BVR‐1B), Influenza, Human
Date of authorisation: 20/05/2020,, Revision: 5, Authorised, Last updated: 16/01/2023
A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/2570/2019 … paraesthesia and tonic-clonic limb movements during recovery … and preferably on different limbs. It should be noted that the … -
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Human medicine European public assessment report (EPAR): Fluenz Tetra
A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444, Influenza, Human
Date of authorisation: 04/12/2013, Revision: 22, Authorised, Last updated: 01/08/2022CHMP) 16-19 September 2013 20/09/2013 Topics: Medicines … Date of this report: 24/09/2015 Deadline for comments … nasal) A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020 … -
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Human medicine European public assessment report (EPAR): Intanza
influenza virus (inactivated, split) of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type), Influenza, Human; Immunization
Date of authorisation: 24/02/2009, Revision: 18, Withdrawn, Last updated: 04/09/2018WC500033848_sv.pdf 07/04/2009 04/09/2018 Generic More detail … EPAR was last updated on 04/09/2018 Authorisation details … strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009 … -
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Human medicine European public assessment report (EPAR): IDflu
influenza virus (inactivated, split) of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type), Influenza, Human; Immunization
Date of authorisation: 24/02/2009, Revision: 13, Withdrawn, Last updated: 29/03/2018strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009 … strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009 … -
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Human medicine European public assessment report (EPAR): Optaflu
influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Brisbane/10/2010, wild type)A/Switzerland/9715293/2013 (H3N2) - like strain(A/South Australia/55/2014, wild type)B/Phuket/3073/2013–like strain(B/Utah/9/2014, wild type), Influenza, Human; Immunization
Date of authorisation: 01/06/2007, Revision: 16, Withdrawn, Last updated: 27/06/2017strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Brisbane/10/2010 … A/California/7/2009 (H1N1)pdm09-like strain; A/Switzerland/9715293/2013 … regarding the AE term Extensive Limb Swelling (ELS) and announced … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fluenz, Influenza Virus Type A, H3N2Influenza Virus Type A, H1N1Influenza Virus Type B
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-000249-PIP01-10, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray suspension
Decision date: 03/01/2011, Last updated: 07/02/2011, Compliance check: Xstrains:A/California/7/2009 (H1N1)pdm09 like strain, A/Victoria/361/2011 …