17101 results
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Withdrawn application: Parsaclisib Incyte Biosciences Distribution B.V.
parsaclisib, date of withdrawal: 27/06/2022, Initial authorisation, Last updated: 08/11/2022Biosciences Distribution B.V.: Withdrawn application … Biosciences Distribution B.V. withdrew the application … Biosciences Distribution B.V., for the treatment of marginal … -
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Human medicine European public assessment report (EPAR): Lamivudine Teva Pharma B.V.
lamivudine, HIV Infections
Date of authorisation: 10/12/2009,
, Revision: 18, Authorised, Last updated: 18/01/2022
Lamivudine Teva Pharma B.V. Blood-Borne Infections Communicable … is Lamivudine Teva Pharma B.V.? Lamivudine Teva Pharma B.V. is an antiviral medicine … mg). Lamivudine Teva Pharma B.V. is a ‘generic medicine’ … -
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Human medicine European public assessment report (EPAR): Imatinib Teva B.V.
imatinib mesilate, Dermatofibrosarcoma; Gastrointestinal Stromal Tumors; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 15/11/2017,, Withdrawn, Last updated: 09/10/2018
Imatinib Teva B.V. Dermatofibrosarcoma Gastrointestinal … Imatinib Teva B.V. … Imatinib Teva B.V. imatinib imatinib mesilate … -
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Human medicine European public assessment report (EPAR): Ribavirin Teva Pharma B.V.
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 01/07/2009,, Revision: 14, Withdrawn, Last updated: 09/07/2021
Ribavirin Teva Pharma B.V. Hepatitis C, Chronic … Ribavirin Teva Pharma B.V. … and Ribavirin Teva Pharma B.V.) some of the studies that … -
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Opinion/decision on a Paediatric investigation plan (PIP): Live bacterium B. thetaiotaomicron
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Gastroentology-Hepatology
PIP number: Live bacterium B. thetaiotaomicron, Route(s) of administration: Oral use, Pharmaceutical form(s): Live Bacteria in an Enteric Coated Capsule
Decision date: 21/08/2009, Last updated: 22/10/2009, Compliance check: XLive bacterium B. thetaiotaomicron Gastroentol … Key facts Live bacterium B. thetaiotaomicron Gastroentology-HepatologyP/166/2009Live … Gastroentology-HepatologyP/166/2009Live bacterium B. thetaiotaomicron Live Bacteria … -
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Pharma B.V.
clopidogrel (as hydrobromide), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 16/06/2011,, Revision: 4, Withdrawn, Last updated: 03/02/2015
Clopidogrel Teva Pharma B.V. Peripheral Vascular Diseases Acute … for Clopidogrel Teva Pharma B.V. has been withdrawn at the … documents Clopidogrel Teva Pharma B.V. : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Generics B.V.
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/10/2010,, Revision: 3, Withdrawn, Last updated: 12/05/2014
Clopidogrel Teva Generics B.V. Peripheral Vascular Diseases Acute … Clopidogrel Teva Generics B.V. has lapsed because it has … Clopidogrel Teva Generics B.V. : EPAR - Summary for the … -
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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: 23/08/2021virus strain Onderstepoort: 105.1 – 106.5 TCID50 Live recombinant canine … canine parvovirus strain 630a: 105.1 – 106.7 TCID50 International non-proprietary … Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands … -
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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V.
budesonide, formoterol, Asthma
Date of authorisation: 19/11/2014, Revision: 1, Withdrawn, Last updated: 30/01/2017onide/Formoterol Teva Pharma B.V. Asthma … Budesonide/Formoterol Teva Pharma B.V. has been withdrawn at the … Budesonide/Formoterol Teva Pharma B.V.: EPAR - Summary for the public … -
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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V.
budesonide, formoterol fumarate dihydrate, Asthma; Pulmonary Disease, Chronic Obstructive
Date of authorisation: 03/04/2020, Revision: 2, Authorised, Last updated: 08/12/2021onide/Formoterol Teva Pharma B.V. Lung Diseases, Obstructive Lung … Budesonide/Formoterol Teva Pharma B.V. is a medicine used for the … Budesonide/Formoterol Teva Pharma B.V. is also used to relieve the … -
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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 … enquiries Emergent Netherlands B.V. Email: schlimmew@ebsi.com … attenuated, oral (strain CVD 103-HgR) for prevention of disease … -
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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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Human medicine European public assessment report (EPAR): Bimervax (new)
SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains, COVID-19 virus infection
Date of authorisation: 30/03/2023,
, Authorised, Last updated: 31/03/2023
may affect more than 1 in 10 people) are pain at the … may affect less than 1 in 10 people. Insomnia (difficulty … may affect less than 1 in 100 people. Paraesthesia (unusual … -
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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 … Kingdom, for 4,6,8-trihydroxy-10-(3,7,11-trimethyldodeca-2,6,10-trienyl)-5,10-dihydrodibenzo[b,e][1,4 … affected approximately 1 in 10,000 people in the European Union … -
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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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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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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): 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 … for the product. II/0005 B.II.b.3.b - Change in the manufacturing … -
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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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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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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): 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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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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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 … authorisation of the medicine Ketabel 100 mg/ml solution for injection … for injection and contains 100 mg ketamine as active substance …