For help on how to get the results you want, see our search tips.
48 results
-
List item
Human medicine European public assessment report (EPAR): ATryn
Antithrombin alfa, Antithrombin III Deficiency
Date of authorisation: 28/07/2006,
, 
, Revision: 16, Withdrawn, Last updated: 02/07/2019
-
List item
Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 16/10/2009,, Revision: 6, Authorised, Last updated: 18/01/2019
-
List item
Human medicine European public assessment report (EPAR): Ceplene
Histamine dihydrochloride, Leukemia, Myeloid, Acute
Date of authorisation: 07/10/2008,, , Revision: 12, Authorised, Last updated: 01/08/2018
-
List item
Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)
Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous, Metabolism, Inborn Errors
Date of authorisation: 10/04/2017,, 
, , Revision: 3, Authorised, Last updated: 24/11/2017
-
List item
Human medicine European public assessment report (EPAR): Glybera
alipogene tiparvovec, Hyperlipoproteinemia Type I
Date of authorisation: 25/10/2012,, , , Revision: 8, Withdrawn, Last updated: 30/10/2017
-
List item
Human medicine European public assessment report (EPAR): Pumarix
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) , Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 04/03/2011,, Revision: 4, Withdrawn, Last updated: 17/03/2015
-
List item
Human medicine European public assessment report (EPAR): Daronrix
Whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)* produced in eggs, Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 21/03/2007,, Withdrawn, Last updated: 02/07/2013
-
List item
Human medicine European public assessment report (EPAR): Rilonacept Regeneron (previously Arcalyst)
Rilonacept, Cryopyrin-Associated Periodic Syndromes
Date of authorisation: 23/10/2009,, Revision: 5, Withdrawn, Last updated: 30/10/2012
-
List item
Veterinary medicine European public assessment report (EPAR): Poulvac Flufend H5N3 RG
recombinant inactivated avian influenza virus, Chicken, Ducks
Date of authorisation: 01/09/2006,
, , Revision: 8, Withdrawn, Last updated: 07/05/2012
-
List item
Human medicine European public assessment report (EPAR): Xigris
drotrecogin alfa (activated), Sepsis, Multiple Organ Failure
Date of authorisation: 22/08/2002,, Revision: 13, Withdrawn, Last updated: 21/02/2012
-
List item
Human medicine European public assessment report (EPAR): Onsenal
Celecoxib, Adenomatous Polyposis Coli
Date of authorisation: 17/10/2003,, Revision: 13, Withdrawn, Last updated: 06/04/2011
-
List item
Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H5N6
inactivated whole avian influenza virus antigen of H5 subtype (strain H5N6, A/duck/Potsdam/2243/84), Chicken
Date of authorisation: 31/01/2008,, , Revision: 1, Withdrawn, Last updated: 26/07/2010
-
List item
Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H7N1
inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99), Chicken, Ducks
Date of authorisation: 14/05/2007,, , Revision: 2, Withdrawn, Last updated: 26/07/2010
-
List item
Human medicine European public assessment report (EPAR): Zabdeno
Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain, Hemorrhagic Fever, Ebola
Date of authorisation: 01/07/2020,, , Authorised, Last updated: 23/07/2020
-
List item
Human medicine European public assessment report (EPAR): Elzonris
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,, , , Authorised, Last updated: 25/01/2021
-
List item
Human medicine European public assessment report (EPAR): Obiltoxaximab SFL
Obiltoxaximab, Anthrax
Date of authorisation: 18/11/2020,, , , Authorised, Last updated: 27/11/2020
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Foclivia, Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001830-PIP01-15-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 15/05/2020, Last updated: 04/03/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Lojuxta, Lomitapide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001124-PIP01-10-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Age-appropriate dosage form, other
Decision date: 10/09/2019, Last updated: 26/03/2020, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Strensiq, asfotase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000987-PIP01-10-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/05/2019, Last updated: 30/10/2019, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Obizur, susoctocog alfa
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000753-PIP02-16, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Glybera, alipogene tiparvovec
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000292-PIP01-08-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 04/11/2016, Last updated: 23/01/2017, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Pumarix, Purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005(H5N1) like strain used (PR8-IBCDC-RG2)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000178-PIP01-07-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 08/05/2015, Last updated: 15/06/2015, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): ATryn, Antithrombin alfa
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001154-PIP01-11, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 27/09/2011, Last updated: 18/10/2011, Compliance check: X