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10091 results
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Veterinary medicine European public assessment report (EPAR): Activyl
indoxacarb, Dogs, Cats
Date of authorisation: 18/02/2011, Revision: 8, Authorised, Last updated: 05/04/2019 -
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Veterinary medicine European public assessment report (EPAR): Activyl Tick Plus
indoxacarb, permethrin, Dogs
Date of authorisation: 09/01/2012, Revision: 8, Authorised, Last updated: 19/11/2020 -
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Human medicine European public assessment report (EPAR): Actos
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 13/10/2000, Revision: 27, Authorised, Last updated: 04/03/2021 -
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Human medicine European public assessment report (EPAR): Actraphane
insulin human, Diabetes Mellitus
Date of authorisation: 07/10/2002, Revision: 19, Authorised, Last updated: 15/10/2020 -
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Human medicine European public assessment report (EPAR): Actrapid
human insulin, Diabetes Mellitus
Date of authorisation: 07/10/2002, Revision: 17, Authorised, Last updated: 21/10/2020 -
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Orphan designation: Humanised monoclonal antibody against P-selectin (crizanlizumab) for: Treatment of sickle cell disease
Date of first decision: 09/08/2012, Positive, Last updated: 24/11/2020 -
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Human medicine European public assessment report (EPAR): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,
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, Authorised, Last updated: 24/11/2020
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Referral: Adartrel
ropinirole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/09/2005, EC decision date: 03/04/2006, Last updated: 21/04/2006 -
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Human medicine European public assessment report (EPAR): Adasuve
loxapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 20/02/2013, Revision: 12, Authorised, Last updated: 28/06/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Adasuve, loxapine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001115-PIP01-10-M07, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, pre-dispensed
Decision date: 04/12/2019, Last updated: 01/04/2020, Compliance check: X -
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Orphan designation: Brentuximab vedotin for: Treatment of cutaneous T-cell lymphoma
Date of first decision: 11/01/2012, Positive, Last updated: 26/08/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP02-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 07/08/2015, Last updated: 17/12/2015, Compliance check: X -
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Human medicine European public assessment report (EPAR): Adcetris
Brentuximab vedotin, Lymphoma, Non-Hodgkin, Hodgkin Disease
Date of authorisation: 25/10/2012,, , , Revision: 28, Authorised, Last updated: 18/12/2020
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP01-10-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 22/06/2020, Last updated: 17/03/2021, Compliance check: X -
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Orphan designation: monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E (brentuximab vedotin) for: Adjunctive treatment in haematopoietic cell transplantation
Date of first decision: 15/01/2009, Positive, Last updated: 26/08/2020 -
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Orphan designation: monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E for: Treatment of peripheral T-cell lymphoma
Date of first decision: 21/09/2019, Positive, Last updated: 26/08/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000980-PIP04-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 08/10/2018, Last updated: 11/01/2019, Compliance check: X -
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Human medicine European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 01/10/2008, Revision: 13, Authorised, Last updated: 10/02/2021 -
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Human medicine European public assessment report (EPAR): Adempas
riociguat, Hypertension, Pulmonary
Date of authorisation: 27/03/2014,, Revision: 10, Authorised, Last updated: 29/04/2019
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Opinion/decision on a Paediatric investigation plan (PIP): Adempas, riociguat
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000718-PIP01-09-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral liquid
Decision date: 04/11/2016, Last updated: 19/01/2017, Compliance check: X -
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Orphan designation: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carbamate (riociguat) for: Treatment of pulmonary arterial hypertension
Date of first decision: 20/12/2007, Positive, Last updated: 05/09/2017 -
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Withdrawn application: Adempas
riociguat, date of withdrawal: 11/08/2016, Post-authorisation, Last updated: 16/09/2016 -
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Human medicine European public assessment report (EPAR): Adenuric
febuxostat, Gout
Date of authorisation: 21/04/2008, Revision: 19, Authorised, Last updated: 06/08/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Adenuric, febuxostat
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001417-PIP01-12-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 20/07/2018, Last updated: 22/11/2018, Compliance check: X -
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Herbal medicinal product: Adhatodae vasicae folium
Adhatoda vasica Nees, Malabar-nut leaf, F: Assessment finalised, Last updated: 30/04/2018