17418 results
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Referral: Ketabel 100 mg/ml solution for injection and associated names
ketamine, associated names: Ketabel vet. 100 mg/ml solution for injection, Belatamin 100 mg/ml solution for injection, Belatamin vet. 100 mg/ml solution for injection, Article 33
Status: European Commission final decision, opinion/position date: 05/12/2019, EC decision date: 04/03/2020, Last updated: 16/04/2020Ketabel 100 mg ml solution for injection and … authorisation of the medicine Ketabel 100 mg ml solution for injection and … for injection and contains 100 mg ketamine as active substance … -
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Orphan designation: Adeno-associated virus of serotype rh10 encoding Human MLC1 under the control of GFAP promoter for: Treatment of megalencephalic leukoencephalopathy with subcortical cysts
Date of designation: 15/10/2021, Positive, Last updated: 11/11/2022sociated virus of serotype rh10 encoding Human MLC1 under the control of GFAP … affecting not more than five in 10,000 people in the European Union … leukoencephalopathy with subcortical cysts (MLC) in the European Union on … -
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Referral: Prontax 10 mg/ml solution for injection for cattle, sheep and pigs
doramectin, associated names: Dectomax 10 mg/ml solution for injection for cattle sheep and pigs, Article 33
Status: European Commission final decision, opinion/position date: 08/02/2012, EC decision date: 25/05/2012, Last updated: 05/07/2012Prontax 10 mg ml solution for injection for … decision Overview Prontax 10 mg ml solution for injection for … arthropods. The applicant, Pfizer Limited, submitted an application … -
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Veterinary medicine European public assessment report (EPAR): Nobivac DP Plus
Live attenuated canine distemper virus strain Onderstepoort: 105.1 – 106.5 TCID50, Live recombinant canine parvovirus strain 630a: 105.1 – 106.7 TCID50, Dogs (small)
Date of authorisation: 09/12/2020, Authorised, Last updated: 23/08/2021as a single injection of 1 ml under the skin. It can only … may affect more than 1 in 10 animals) is a small, non-painful … Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands … -
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Orphan designation: 4,6,8-Trihydroxy-10-(3,7,11-trimethyldodeca-2,6,10-trienyl)-5,10-dihydrodibenzo[b,e][1,4] diazepin-11-one for: Treatment of glioma
Date of designation: 15/05/2009, Withdrawn, Last updated: 17/10/20134,6,8-Trihydroxy-10-(3,7,11-trimethyldodeca-2,6,10-trienyl)-5,10-dihydrodibenzo[b,e][1,4 … Albany Regulatory Consulting Limited, United Kingdom, for 4,6,8-tri … Kingdom, for 4,6,8-trihydroxy-10-(3,7,11-trimethyldodeca-2,6,10-trienyl)-5,10-dihydrodibenzo[b,e][1,4 … -
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Orphan designation: 20-pentaerythritol poly (oxy-1,2-ethanediyl)-carboxymethyl-glycinate-7-ethyl-10-hydroxycamptothecine 10-[1,4'-bipiperidine]-1'-carboxylate for: Treatment of ovarian cancer
Date of designation: 27/09/2011, Positive,oxy-1,2-ethanediyl)-carboxymethyl-glycinate-7-ethyl-10-hydroxycamptothecine 10-[1,4'-bipiperidine]-1'-carboxylate Overview On 27 September … oxy-1,2-ethanediyl)-carboxymethyl-glycinate-7-ethyl-10-hydroxycamptothecine 10-[1,4'-bipiperidine]-1'-carboxylate for the treatment of ovarian … -
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Veterinary medicine European public assessment report (EPAR): Versican Plus L4
Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090, L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091 (all inactivated), Dogs
Date of authorisation: 30/07/2014, Revision: 4, Authorised, Last updated: 17/05/2019effect (seen in more than 1 in 100 dogs) with Versican Plus … application/pdf WC500175885_sv.pdf 20/10/2014 20 10/2014 EMA/335824/2014 Generic … serovar Bratislava, strain MSLB 1088, L. interrogans serogroup … -
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Direct healthcare professional communication (DHPC): Hiprabovis IBR Marker Live (infectious bovine rhinotracheitis vaccine (live)) - Increase in the incidence of anaphylactic-type reactions in cattle
Active substance: live gE- tk- double-gene-deleted bovine herpes virus type 1, strain CEDDEL: 106.3–107.3 CCID50, DHPC type: Adverse event, Last updated: 11/08/2022virus type 1, strain CEDDEL: 106.3–107.3 CCID50 Procedure number EMEA/V/C/000158 … virus type 1, strain CEDDEL: 106.3–107.3 CCID50 live gE- tk- double-gene-deleted … virus type 1, strain CEDDEL: 106.3–107.3 CCID50 … -
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Veterinary medicine European public assessment report (EPAR): Versican Plus Pi/L4
Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (live attenuated), Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090 and L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091 (all inactivated), Dogs
Date of authorisation: 30/07/2014, Revision: 4, Authorised, Last updated: 17/05/2019effect (seen in more than 1 in 100 dogs) with Versican Plus … effect (seen in more than 1 in 100 dogs) with Versican Plus … virus, strain CPiV-2-Bio 15 103.1 TCID50 105.1 TCID50 Solvent (inactivated … -
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Opinion/decision on a Paediatric investigation plan (PIP): Vaxchora, Cholera vaccine, live attenuated, oral (strain CVD 103-HgR)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001490-PIP01-13-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension, Age-appropriate oral liquid dosage form
Decision date: 22/12/2020, Last updated: 22/09/2021, Compliance check: Xattenuated, oral (strain CVD 103-HgR) Therapeutic area Vaccines … attenuated, oral (strain CVD 103-HgR) for prevention of disease … attenuated, oral (strain CVD 103-HgR) for the prevention of disease … -
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Veterinary medicine European public assessment report (EPAR): Hiprabovis IBR Marker Live
live gE- tk- double-gene-deleted bovine herpes virus type 1, strain CEDDEL: 106.3–107.3 CCID50, Cattle
Date of authorisation: 27/01/2011, Revision: 4, Authorised, Last updated: 06/07/2017virus type 1, strain CEDDEL: 106.3–107.3 CCID50live gene-deleted vaccine … marketing authorisation. 10/09/2015 06/11/2015 SPC, Annex II … the medicinal product 08/10/2015 n/a SPC The agency … -
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Opinion/decision on a Paediatric investigation plan (PIP): Anti-IL-17A/F nanobody (MK 1095)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: EMEA-002568-PIP01-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 11/02/2020, Last updated: 10/06/2020, Compliance check: XAnti-IL-17A/F nanobody (MK 1095) DermatologyP/0057/2020EMEA-002568-PIP01-19 … anti-IL-17A/F nanobody (MK 1095) (EMEA-002568-PIP01-19) PDF … 002568-pip01-19_en.pdf Adopted 10/06/2020 EMA/12614/2020 Generic Topics: … -
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Orphan designation: Sodium (4Z,7Z,10R,11E,13E,15Z,17S,19Z)10,17-dihydroxy-docosa-4,7,11,13,15,19-hexaenoate for: Prevention of retinopathy of prematurity
Date of designation: 21/06/2022, Positive, Last updated: 15/09/2022Sodium (4Z,7Z,10R,11E,13E,15Z,17S,19Z)10,17-dihydroxy-docosa-4,7,11,13,15,19-hexaenoate … affecting not more than five in 10,000 people in the European Union … affecting not more than five in 10,000 people in the European Union … -
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Opinion/decision on a Paediatric investigation plan (PIP): (6aR,10aR)-1-Hydroxy-6,6-dimethyl-3-(2-methyl-2-octanyl)-6a,7,10,10a-tetrahydro-6H- benzo[c]chromene-9-carboxylic acid (lenabasum)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002069-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral formulation, Tablet
Decision date: 22/03/2019, Last updated: 24/06/2019, Compliance check: XActive substance (6aR,10aR)-1-Hydroxy-6,6-dimethyl-3-(2-methyl-2-octanyl)-6a,7,10,10a-tetrahydro-6H … 6aR,10aR)-1-Hydroxy-6,6-dimethyl-3-(2-methyl-2-octanyl)-6a,7,10,10a-tetrahydro-6H … -
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Human medicine European public assessment report (EPAR): Vaxchora
vibrio cholerae, strain cvd 103-hgr, live, Cholera
Date of authorisation: 01/04/2020,
, Revision: 6, Authorised, Last updated: 27/09/2022
as a single dose at least 10 days before the person is … given the cholera bacteria 10 days after Vaxchora and 12 … may affect more than 1 in 10 people) are tiredness, headache … -
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Veterinary medicine European public assessment report (EPAR): Versican Plus DHPPi/L4
canine distemper virus, strain CDV Bio 11/A, canine adenovirus type 2, strain CAV-2 Bio 13, canine parvovirus type 2b, strain CPV-2b Bio 12/B, canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (all live attenuated), Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090, L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091..., Dogs
Date of authorisation: 06/05/2014, Revision: 6, Authorised, Last updated: 16/05/2019parvovirus ranged from 73 to 100%, for parainfluenza virus 73 … effect (seen in more than 1 in 100 dogs) with Versican Plus … parvovirus ranged from 73 to 100%, for parainfluenza virus … -
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Veterinary medicine European public assessment report (EPAR): Versican Plus DHPPi/L4R
canine distemper virus, strain CDV Bio 11/A, canine adenovirus type 2, strain CAV-2 Bio 13, canine parvovirus type 2b, strain CPV-2b Bio 12/B, canine parainfluenza type 2 virus, strain CPiV-2 Bio 15 (all live attenuated), Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088, L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain MSLB 1089, L. interrogans serogroup Canicola serovar Canicola, strain MSLB 1090, L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091..., Dogs
Date of authorisation: 06/05/2014, Revision: 6, Authorised, Last updated: 16/05/2019parvovirus ranged from 73 to 100%, for parainfluenza virus 73 … and for rabies virus 86 to 100%. Responses in puppies were … effect (seen in more than 1 in 100 dogs) with Versican Plus … -
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Orphan designation: Methyl(R)-4-((3S,5R,7R,8R,9S,10S,13R,14S,17R)-7-hydroxy-10,13-dimethyl-3-((4-((pyridin-3-ylmethyl)amino)butyl)amino)hexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoate for: Treatment of Rett syndrome (new)
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023marketing authorisation ; The 10-year period after the marketing … must not be more than 5 in 10,000 or it must be unlikely that … Methyl(R)-4-((3S,5R,7R,8R,9S,10S,13R,14S,17R)-7-hydroxy … -
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Orphan designation: copper meso-5,15-bis[3-[(1,2-dicarba-closo-dodecaboranyl)methoxy]phenyl]-meso-10,20-dinitroporphyrin for: Treatment of squamous-cell carcinoma of the head and neck in patients undergoing radiotherapy
Date of designation: 27/06/2013, Withdrawn, Last updated: 10/12/2020was transferred to Regintel Limited, Ireland, in June 2019 and … Pharmaconsulting Ireland Limited, Ireland, in July 2020. What … affected approximately 3.7 in 10,000 people in the European Union … -
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Orphan designation: (6aR, 10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydro-cannabinol-9-carboxylic acid for: Treatment of systemic sclerosis
Date of designation: 12/01/2017, Positive, Last updated: 11/08/20206aR, 10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydro-cannabinol-9-carboxylic acid Overview On 12 January … United Kingdom, for (6aR, 10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydro-cannabinol-9-carboxylic acid (also known as JBT 101 or resunab) for the treatment … -
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Orphan designation: N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenamido)ethyl)-2-hydroxybenzamide (edasalonexent) for: Treatment of Duchenne muscular dystrophy
Date of designation: 09/10/2015, Withdrawn, Last updated: 02/09/2021N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7 10,13,16,19-hexaenamido)ethyl)-2-hydroxybenzamide (edasalonexent … Germany, for N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenamido)ethyl)-2-hydroxybenzamide … designation N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19- hexaenamido)ethyl)-2-hydroxybenzamide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fluoride 18-labelled Prostate-Specific Membrane Antigen-1007 ([18F]PSMA-1007)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Diagnostic; Oncology
PIP number: EMEA-002918-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 26/03/2021, Last updated: 09/11/2021, Compliance check: XProstate-Specific Membrane Antigen-1007 ([18F]PSMA 1007) DiagnosticOncologyP/0127/2021EMEA-002918-PIP01-20 … prostate-specific membrane antigen-1007 ([18F]PSMA 1007) (EMEA-002918-PIP01-20) PDF … Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands … -
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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: 04/03/2011EU/3/10/831 … idiotype coupled to keyhole limpet hemocyanin Overview On 23 … orphan designation (EU/3/10/831) was granted by the European … -
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Orphan designation: (1R, 2R, 4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R, 27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetra-cosahydro-3H-23,2 for: Treatment of soft tissue sarcoma
Date of designation: 26/08/2005, Withdrawn, Last updated: 11/03/20134S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R … 27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hex … 11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetra-cosahydro-3H-23,2 … -
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Orphan designation: (1R, 2R, 4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R, 27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetra-cosahydro-3H-23,2 for: Treatment of primary malignant bone tumours
Date of designation: 28/10/2005, Withdrawn, Last updated: 11/03/20134S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R … 27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hex … 11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetra-cosahydro-3H-23,2 …