18770 results
-
List item
Human medicine European public assessment report (EPAR): Jakavi (updated)
ruxolitinib (as phosphate), Myeloproliferative Disorders, Polycythemia Vera
Date of authorisation: 23/08/2012, Revision: 24, Authorised, Last updated: 04/08/2021 -
List item
Human medicine European public assessment report (EPAR): Azacitidine Celgene (updated)
azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 02/08/2019, Revision: 2, Withdrawn, Last updated: 04/08/2021 -
List item
Human medicine European public assessment report (EPAR): Imraldi (updated)
adalimumab, Hidradenitis Suppurativa, Psoriasis, Crohn Disease, Uveitis, Arthritis, Rheumatoid, Arthritis, Colitis, Ulcerative, Spondylitis, Ankylosing, Arthritis, Psoriatic
Date of authorisation: 24/08/2017,
, 
, Revision: 15, Authorised, Last updated: 04/08/2021
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): (2S,4S)-2-(4-Carboxyphenyl)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-1-ium chloride―water (1/1) (LNP023) (new)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-002705-PIP02-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Capsule, hard
Decision date: 23/10/2020, Last updated: 04/08/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Doravirine, Islatravir (new)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-002707-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Tablets
Decision date: 23/10/2020, Last updated: 04/08/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tiragolumab (new)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002721-PIP02-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for suspension for infusion
Decision date: 23/10/2020, Last updated: 04/08/2021, Compliance check: X -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Tiragolumab (new)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002721-PIP03-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for suspension for infusion
Decision date: 22/10/2020, Last updated: 04/08/2021, Compliance check: X -
List item
News: ECDC and EMA update on COVID-19 (new)
Last updated: 04/08/2021 -
List item
COVID-19 vaccines: key facts (updated)
Last updated: 04/08/2021 -
List item
COVID-19: latest updates (updated)
Last updated: 04/08/2021 -
List item
Human medicine European public assessment report (EPAR): Lemtrada (updated)
alemtuzumab, Multiple Sclerosis
Date of authorisation: 12/09/2013,
, , Revision: 14, Authorised, Last updated: 04/08/2021
-
List item
Human medicine European public assessment report (EPAR): Pelmeg (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/11/2018,, , Revision: 5, Authorised, Last updated: 04/08/2021
-
List item
Orphan designation: adeno-associated virus serotype 2/6 encoding human alpha-galactosidase A cDNA for: Treatment of Fabry disease (updated)
Date of designation: 09/01/2020, Positive, Last updated: 04/08/2021 -
List item
Veterinary medicine European public assessment report (EPAR): Credelio Plus (updated)
lotilaner, milbemycin oxime, Dogs
Date of authorisation: 14/04/2021, Authorised, Last updated: 04/08/2021 -
List item
Orphan designation: poly(oxy-1,2-ethanediyl), alpha-(carboxymethyl)-omega-methoxy-, amide with arginase 1 [cobalt cofactor] (synthetic human) (1:10), trimer (pegzilarginase) for: Treatment of hyperargininaemia (updated)
Date of designation: 14/07/2016, Positive, Last updated: 04/08/2021 -
List item
Human medicine European public assessment report (EPAR): Opatanol (updated)
olopatadine hydrochloride, Conjunctivitis, Allergic
Date of authorisation: 16/05/2002, Revision: 21, Authorised, Last updated: 04/08/2021 -
List item
Scientific publications (updated)
Last updated: 04/08/2021 -
List item
Plasma master file certificates (updated)
Last updated: 04/08/2021 -
List item
Human medicine European public assessment report (EPAR): COVID-19 Vaccine Janssen (updated)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, 
, Revision: 6, Authorised, Last updated: 04/08/2021
-
List item
Human medicine European public assessment report (EPAR): Eylea (updated)
aflibercept, Wet Macular Degeneration, Macular Edema, Diabetes Complications
Date of authorisation: 21/11/2012, Revision: 22, Authorised, Last updated: 03/08/2021 -
List item
Orphan designation: Daratumumab for: Treatment of AL amyloidosis (updated)
Date of designation: 25/05/2018, Positive, Last updated: 03/08/2021 -
List item
Human medicine European public assessment report (EPAR): Darzalex (updated)
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,, 
, 
, Revision: 16, Authorised, Last updated: 03/08/2021
-
List item
EMA’s governance during COVID-19 pandemic (updated)
Last updated: 03/08/2021 -
List item
Human medicine European public assessment report (EPAR): Ifirmasta (previously Irbesartan Krka) (updated)
irbesartan hydrochloride, Hypertension
Date of authorisation: 01/12/2008,
, Revision: 14, Authorised, Last updated: 03/08/2021
-
List item
Website outages and upgrades (updated)
Last updated: 03/08/2021