14305 results
-
List item
Human medicine European public assessment report (EPAR): Hexavac
purified diphtheria toxoid, Purified Tetanus Toxoid, purified pertussis toxoid, purified pertussis filamentous haemagglutinin, hepatitis B surface antigen, Inactivated Type 1 Poliovirus (Mahoney), inactivated type 2 poliovirus (MEF 1), Inactivated Type 3 Poliovirus (Saukett), Haemophilus influenzae type b polysaccharide, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Date of authorisation: 23/10/2000, Withdrawn, Last updated: 16/08/2012phtheria, tetanus, acellular pertussis, inactivated poliomyelitis … diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis … diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis … -
List item
Veterinary medicine European public assessment report (EPAR): Arti-Cell Forte
chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells, Horses
Date of authorisation: 29/03/2019, Revision: 5, Authorised, Last updated: 25/10/2021induced equine allogeneic peripheral blood-derived mesenchymal … positive effects lasted over a period of one year. What are the … are the precautions for the person who gives the medicine or … -
List item
Human medicine European public assessment report (EPAR): Tritanrix HepB
Diphtheria toxoid, hepatitis B surface antigen, Bordetella pertussis (inactivated), tetanus toxoid, Hepatitis B; Tetanus; Immunization; Whooping Cough; Diphtheria
Date of authorisation: 19/07/1996, Revision: 15, Withdrawn, Last updated: 07/01/2014diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis … HepB (diphtheria, tetanus, pertussis (whole cell) and hepatitis-B … GlaxoSmithKline Biologicals, permanently discontinued marketing of … -
List item
Referral: Coversyl
perindopril, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 27/07/2005, EC decision date: 07/11/2005, Last updated: 23/12/2005associated names contain perindopril, a well-known, potent angiotensin … The questions identified pertained to the inclusion of a specific … the beneficial effect of perindopril beyond a mere reduction of … -
List item
Referral: Coversyl
perindopril, Article 30 referrals
Status: European Commission final decision, opinion/position date: 24/07/2003, EC decision date: 04/12/2003, Last updated: 23/12/2003Commission final decision Overview Perindopril is a specific, competitive … renin-angiotensin-aldosteron system. Perindopril was initially approved in … the benefit/risk ratio of perindopril is considered favourable … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomerata, Lolium perenne, Phleum pratense, Festuca pratensis, Secale cereale
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000845-PIP01-10-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 27/11/2015, Last updated: 06/06/2018, Compliance check: XDactylis glomerata, Lolium perenne, Phleum pratense, Festuca … Dactylis glomerata, Lolium perenne, Phleum pratense, Festuca … Dactylis glomerata, Lolium perenne, Phleum pratense, Festuca … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomarata, Lolium perenne, Phleum pratense, Poa pratensis and Anthoxhantum odoratum (20% each)
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-000856-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oralmucosal drops
Decision date: 22/12/2010, Last updated: 24/01/2011, Compliance check: XDactylis glomarata, Lolium perenne, Phleum pratense, Poa pratensis … Dactylis glomarata, Lolium perenne, Phle... PDF icon application/pdf … Dactylis glomarata, Lolium perenne, Phleum pratense, Poa pratensis … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense, Secale cereale (20% each)
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-000864-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oralmucosal drops
Decision date: 22/12/2010, Last updated: 24/01/2011, Compliance check: XFestuca pratensis, Lolium perenne, Phleum pratense, Secale cereale … Festuca pratensis, Lolium perenne, Phleum pratense, Secale cereale … Festuca pratensis, Lolium perenne, Phleum pratense, Secale cereale … -
List item
Withdrawn application: Imagify
date of withdrawal: 24/07/2014, Initial authorisation, Last updated: 04/02/2015authorisation for Imagify (perflubutane) intended to be used for … medicine. active substance perflubutane. It was to be available as … then examined by trained personnel to determine whether or not … -
List item
Summary of opinion: RenuTend
tenogenic primed equine allogeneic peripheral blood-derived mesenchymal stem cells, opinion date: 16/02/2022, Positive, Last updated: 21/02/2022primed equine allogeneic peripheral blood-derived mesenchymal … primed equine allogeneic peripheral blood-derived mesenchymal … primed equine allogeneic peripheral blood-derived mesenchymal … -
List item
Orphan designation: Perflubron for: Treatment of congenital pulmonary hypoplasia
Date of designation: 13/11/2020, Positive, Last updated: 16/09/2021Perflubron … opinion on orphan designation Perflubron for the treatment of congenital … Consultants Limited, Ireland, for perflubron for the treatment of congenital … -
List item
Orphan designation: perflubron for: Treatment of respiratory distress syndrome
Date of designation: 09/12/2020, Positive, Last updated: 16/09/2021perflubron Overview On 9 December 2020 … Consultants Limited, Ireland, for perflubron for the treatment of respiratory … opinion on orphan designation Perflubron for the treatment of respiratory … -
List item
Orphan designation: Peretinoin for: Treatment of hepatocellular carcinoma
Date of designation: 05/08/2011, Positive, Last updated: 26/07/2018Peretinoin … PSO 003-11 Peretinoin 7 Westferry Circus … opinion on orphan designation Peretinoin for the treatment of hepatocellular … -
List item
Orphan designation: Perifosine for: Treatment of multiple myeloma
Date of designation: 10/06/2010, Withdrawn, Last updated: 07/02/2014Perifosine … opinion on orphan designation Perifosine for the treatment of multiple … opinion on orphan designation Perifosine for the treatment of multiple … -
List item
Referral: Basiron AC and associated names
benzoyl peroxide, Article 13 referrals
Status: European Commission final decision, opinion/position date: 28/03/2019, EC decision date: 04/07/2019, Last updated: 19/07/2019authorisation for Basiron AC (benzoyl peroxide 5% and 10% gel) in the EU … benzoyl peroxide … -
List item
Direct healthcare professional communication (DHPC): Arti-Cell® Forte and RenuTend® market recall of select product batches
Active substance: Equine allogeneic mesenchymal stem cells, DHPC type: Quality defect, Last updated: 04/05/2023induced equine allogeneic peripheral blood-derived mesenchymal … primed equine allogeneic peripheral blood-derived mesenchymal … induced equine allogeneic peripheral blood-derived mesenchymal … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Perflubutane
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Cardiovascular diseases
PIP number: Perflubutane, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Lyophilisate for suspension for injection
Decision date: 28/11/2008, Last updated: 29/01/2009, Compliance check: XPerflubutane Cardiovascular diseases … Key facts Perflubutane Cardiovascular diseasesP/106 … Cardiovascular diseasesP/106/2008Perflubutane Lyophilisate for suspension … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Perflubutane
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Diagnostic
PIP number: EMEA-000194-PIP03-10, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for suspension for injection
Decision date: 18/05/2011, Last updated: 09/06/2011, Compliance check: XKey facts Perflubutane DiagnosticP/116/2011EMEA-000194-PIP03-10 … Visualisation of myocardial perfusion for diagnostic purposes Intravenous … granting of a waiver for perflubutane (EMEA-000194-PIP03-10) PDF … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Perflubutane
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Diagnostic; Oncology
PIP number: EMEA-003037-PIP01-21, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for dispersion for injection
Decision date: 22/11/2021, Last updated: 20/02/2023, Compliance check: XKey facts Perflubutane DiagnosticOncologyP/0435/2021EMEA-003037-PIP01-21 … product-specific waiver for perflubutane (EMEA-003037-PIP01-21) PDF … product specific waiver for perflubutane (EMEA-003037-PIP01-21) in … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Aqueous extract of grass pollen from Dactylis glomerata, Festuca pratensis, Holcus lanatus, Lolium perenne, Phleum pratense and Poa pratensis
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: Aqueous extract of grass pollen from Dactylis glomerata, Festuca pratensis, Holcus lanatus, Lolium perenne, Phleum pratense and Poa pratensis, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Solution for sublingual use
Decision date: 20/07/2009, Last updated: 16/09/2009, Compliance check: Xpratensis, Holcus lanatus, Lolium perenne, Phleum pratense and Poa prate … pratensis, Holcus lanatus, Lolium perenne, Phleum pratense and Poa pratensis … pratensis, Holcus lanatus, Lolium perenne, Phleum pratense and Poa pratensis … -
List item
Human medicine European public assessment report (EPAR): Hexacima
hepatitis B surface antigen, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin, poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett), Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 29, Authorised, Last updated: 23/06/2023diphtheria, tetanus, pertussis (acellular, component), hepatitis … Hexacima Diphtheria, tetanus, pertussis (acellular, component), hepatitis … from diphtheria, tetanus, pertussis and Haemophilus influenzae … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense, Poa pratensis, Secale cereale and Artemisia vulgaris
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-000851-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/12/2010, Last updated: 24/01/2011, Compliance check: XFestuca pratensis, Lolium perenne, Phleum pratense, Poa pratensis … Festuca pratensis, Lolium perenne, Phleum pratense, Poa pratensis … Festuca pratensis, Lolium perenne, Phleum pratense, Poa pratensis … -
List item
Human medicine European public assessment report (EPAR): Pergoveris
follitropin alfa, lutropin alfa, Infertility, Female
Date of authorisation: 25/06/2007, Revision: 15, Authorised, Last updated: 31/05/2023Pergoveris Female Urogenital Diseases … assessment report (EPAR) for Pergoveris. It explains how the Agency … practical advice on how to use Pergoveris. For practical information … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, perindopril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002091-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/04/2017, Last updated: 29/05/2017, Compliance check: XActive substance amlodipine perindopril Therapeutic area Cardiovascular … specific waiver for amlodipine / perindopril (EMEA-002091-PIP01-16 … specific waiver for amlodipine / perindopril (EMEA-002091-PIP01-16) in … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): perindopril, amlodipine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001968-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 04/11/2016, Last updated: 10/01/2017, Compliance check: XActive substance perindopril amlodipine Therapeutic area … product specific waiver for perindopril / amlodipine (EMEA-001968-PIP01-16) 30 … product specific waiver for perindopril / amlodipine (EMEA-001968-PIP01-16 …