12258 results
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Opinion/decision on a Paediatric investigation plan (PIP): Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis pollen (grasses-mix) and birch pollen (50/50)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000790-PIP01-09, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 26/11/2010, Last updated: 21/12/2010, Compliance check: Xhydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract … Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne … grasses-mix) and birch pollen (50/50) Pneumology-allergologyP/246/2010EMEA-000790-PIP01-09 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Mixture of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis (Grasses-Mix) and Secale cereale (50/50) allergen extracts
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000922-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal solution
Decision date: 26/11/2010, Last updated: 21/12/2010, Compliance check: XPhleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne … Grasses-Mix) and Secale cereale (50/50) allergen extracts Pneumology-allergologyP/262/2010EMEA-000922-PIP01-10 … Phleum pratense, Dactylis glomerata, Festu... PDF icon application/pdf … -
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Opinion/decision on a Paediatric investigation plan (PIP): Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract of equal amounts of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis pollen (Grasses-Mix) and Secale cereale (cultivated rye) pollen (50/50)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000792-PIP01-09-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: Xhydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract … Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne … cultivated rye) pollen (50/50) Pneumology-allergologyP/0392/2017EMEA-000792-PIP01-09-M01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and poa pratensis pollen (grasses-mix) and birch, alder and hazel pollen (tree-mix) (50/50)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000789-PIP01-09, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 26/11/2010, Last updated: 20/12/2010, Compliance check: Xhydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract … Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne … hazel pollen (tree-mix) (50/50) Pneumology-allergologyP/245/2010EMEA-000789-PIP01-09 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extracts of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis pollen (Grasses-Mix) and Secale cereale (Cultivated Rye) pollen (50/50)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000841-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 26/11/2010, Last updated: 21/12/2010, Compliance check: Xhydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extracts … Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne … Cultivated Rye) pollen (50/50) Pneumology-allergologyP/257/2010EMEA-000841-PIP01-10 … -
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Orphan designation: N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine for: Treatment in solid organ transplantation
Date of designation: 13/04/2022, Positive, Last updated: 19/07/2022N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn … 2.1.4. n-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3- phosphatidylethanolamine … 11 2.2.1. glofitamab - EMA/OD/0000070101 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract of equal amounts of Phleum pratense pollen and Secale cereale (cultivated rye) pollen (50/50)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000793-PIP01-09, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 26/11/2010, Last updated: 21/12/2010, Compliance check: Xhydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract … cultivated rye) pollen (50/50) Pneumology-allergologyP/249/2010EMEA-000793-PIP01-09 … hydroxide adsorbed, depigmented glutaralde... PDF icon application/pdf WC … -
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Veterinary medicine European public assessment report (EPAR): Aftovaxpur DOE
Maximum three of the following purified, inactivated foot-and-mouth disease virus strains: O1 Manisa ≥ 6 PD50*; O1 BFS ≥ 6 PD50*; O Taiwan 3/97 ≥ 6 PD50*; A22 Iraq ≥ 6 PD50*; A24 Cruzeiro ≥ 6 PD50*; A Turkey 14/98 ≥ 6 PD50*; Asia 1 Shamir ≥ 6 PD50*; SAT2 Saudi Arabia ≥ 6 PD50*; * PD50 – 50% protective dose in cattle as described in Ph. Eur. monograph 0063., Pigs; Cattle; Sheep
Date of authorisation: 15/07/2013,
Date of refusal: 16/05/2013, Revision: 8, Authorised, Last updated: 27/03/2020PDF icon application/pdf WC500147982_en.pdf PDF icon application/pdf … PDF icon application/pdf WC500147982_bg.pdf PDF icon application/pdf … PDF icon application/pdf WC500147982_es.pdf PDF icon application/pdf … -
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Referral: Doxyfar 50%
doxycycline hyclate, associated names: Soludox 500 mg/g, Soludox Vet, Soludox 433 mg/g, Doxy Ort 50%, Article 34
Status: European Commission final decision, opinion/position date: 04/05/2011, EC decision date: 13/07/2011, Last updated: 24/08/2011Doxyfar 50% … and some protozoa. Doxyfar 50 % and associated names is … substance doxycycline hyclate 500 mg/g. The product is indicated … -
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Referral: Doxycycline 50% WSP
doxycycline hyclate, associated names: Doxymed 50, Vetadoxi 50, Doxylin Vet, Doxycycline Dophama, Article 34
Status: European Commission final decision, opinion/position date: 04/05/2011, EC decision date: 13/07/2011, Last updated: 24/08/2011Doxycycline 50% WSP … some protozoa. Doxycycline 50% WSP and associated names … substance doxycycline hyclate 500 mg/g. In pigs and pre-ruminant … -
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Orphan designation: 505 amino acid protein, corresponding to amino acids 2-506 of the wild type human histidyl-tRNA synthetase for: treatment of facioscapulohumeral muscular dystrophy
Date of designation: 12/02/2015, Withdrawn, Last updated: 12/02/2020505 amino acid protein, corresponding … corresponding to amino acids 2-506 of the wild type human histidyl-tRNA … 505 amino acid protein, corresponding … -
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Orphan designation: 505 amino acid protein, corresponding to amino acids 2-506 of the wild-type human histidyl-tRNA synthetase for: Treatment of limb-girdle muscular dystrophy
Date of designation: 27/02/2017, Withdrawn, Last updated: 12/02/2020505 amino acid protein, corresponding … corresponding to amino acids 2-506 of the wild-type human histidyl-tRNA … 505 amino acid protein, corresponding … -
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Opinion/decision on a Paediatric investigation plan (PIP): Angiotensin II (LJPC-501)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001912-PIP02-16-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 15/04/2019, Last updated: 30/06/2021, Compliance check: Xfacts Angiotensin II (LJPC-501) Cardiovascular diseasesP/0159/2019EMEA-001912-PIP02-16-M02 … for angiotensin II (LJPC-501) (EMEA-001912-PIP02-16-M02 … Angiotensin II (LJPC-501 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Angiotensin II (LJPC-501)
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Other
PIP number: EMEA-001912-PIP01-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 26/09/2016, Last updated: 27/10/2016, Compliance check: Xfacts Angiotensin II (LJPC-501) OtherP/0253/2016EMEA-001912-PIP01-15 … for angiotensin II (LJPC-501) (EMEA-001912-PIP01-15) PDF … PDF icon application/pdf WC500215399_en.pdf Adopted 27/10/2016 … -
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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: 23/08/2021Onderstepoort: 105.1 – 106.5 TCID50 Live recombinant canine parvovirus … 630a: 105.1 – 106.7 TCID50 International non-proprietary … Dogs Subcutaneous use Vial (glass) Lyophilisa te: 1 dose … -
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Opinion/decision on a Paediatric investigation plan (PIP): Purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05 (H5N1)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: Purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05 (H5N1), Route(s) of administration: Intramuscular injection, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 24/04/2009, Last updated: 26/11/2020, Compliance check: Xvirion Influenza A/Indonesia/5/05 (H5N1) Vaccines … virion Influenza A/Indonesia/5/05 (H5N1) VaccinesP/79/2009Purified … virion Influenza A/Indonesia/5/05 (H5N1) Emulsion and suspension … -
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Orphan designation: Antisense oligonucleotide targeting the F508delta mutation of CFTR (eluforsen) for: Treatment of cystic fibrosis
Date of designation: 07/10/2013, Withdrawn, Last updated: 18/12/2020oligonucleotide targeting the F508delta mutation of CFTR for … cells in the lungs, and the glands in the gut and pancreas … protein in patients with the F508delta mutation in their CFTR … -
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Opinion/decision on a Paediatric investigation plan (PIP): N-{2-(2,3-Difluorobenzylthio)-6-[(2R,3S)-3,4-dihydroxybut-2-yloxy]pyrimidin-4-yl}azetidine-1-sulfonamide (AZD5069)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001571-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 02/05/2014, Last updated: 06/06/2014, Compliance check: XN-{2-(2,3-Difluorobenzylthio)-6-[(2R,3S)-3,4-dihydroxybut-2-yloxy]pyrimidin-4-yl}azetidine-1-sulfonamide (AZD5069) Therapeutic area Pneumology-allergology … N-{2-(2,3-Difluorobenzylthio)-6-[(2R,3S)-3,4-dihydroxybut-2-yloxy]pyrimidin- 4-yl}azetidine-1-sulfonamide (AZD5069) (EMEA-001571-PIP01-13) in … -
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Referral: Gluscan 500
fludeoxyglucose (18F), Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 20/03/2009, EC decision date: 29/05/2009, Last updated: 23/06/2009Gluscan 500 … authorisation of the medicine Gluscan 500. The Agency's Committee for … concluded that the benefits of Gluscan 500 outweigh its risks, and the … -
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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: 11/08/2022CEDDEL: 106.3–107.3 CCID50 Procedure number EMEA/V/C/000158 … CEDDEL: 106.3–107.3 CCID50 live gE- tk- double-gene-deleted … CEDDEL: 106.3–107.3 CCID50 … -
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Human medicine European public assessment report (EPAR): Mircera
Methoxy polyethylene glycol-epoetin beta, Anemia; Kidney Failure, Chronic
Date of authorisation: 20/07/2007, Revision: 28, Authorised, Last updated: 20/03/2023horised methoxy polyethylene glycol-epoetin beta Overview This is a summary … substance methoxy polyethylene glycol-epoetin beta. It is available in … various strengths ranging from 50 to 1,000 micrograms per millilitre … -
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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: 06/07/2017PDF icon application/pdf WC500101815_en.pdf PDF icon application/pdf … PDF icon application/pdf WC500101815_bg.pdf PDF icon application/pdf … PDF icon application/pdf WC500101815_es.pdf PDF icon application/pdf … -
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Veterinary medicine European public assessment report (EPAR): Oxyglobin
haemoglobin glutamer-200 (bovine), Dogs
Date of authorisation: 29/11/1999, Revision: 16, Authorised, Last updated: 20/10/2020Authorised Haemoglobin glutamer-200 (bovine) Overview This is … contains bovine haemoglobin glutamer-200 (at a strength of 130 mg/ml … solution. It contains haemoglobin glutamer-200, which is made from haemoglobin … -
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Human medicine European public assessment report (EPAR): Semglee (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018,
, 
, Revision: 8, Authorised, Last updated: 23/05/2023
Diseases Metabolic Diseases Glucose Metabolism Disorders Endocrine … Authorised insulin glargine Overview Semglee is a medicine … active substance insulin glargine. Semglee is a ‘ A medicine … -
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Human medicine European public assessment report (EPAR): Apidra
insulin glulisine, Diabetes Mellitus
Date of authorisation: 27/09/2004, Revision: 31, Authorised, Last updated: 13/12/2021Endocrine System Diseases Glucose Metabolism Disorders Metabolic … Active substance insulin glulisine International non-proprietary … INN) or common name insulin glulisine Therapeutic area (MeSH) Diabetes …