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9736 results
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Human medicine European public assessment report (EPAR): Abasaglar (previously Abasria)
insulin glargine, Diabetes Mellitus
Date of authorisation: 09/09/2014,
, Revision: 9, Authorised, Last updated: 23/09/2020
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Human medicine European public assessment report (EPAR): Abilify
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 04/06/2004, Revision: 47, Authorised, Last updated: 20/10/2020 -
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Opinion/decision on a Paediatric investigation plan (PIP): Abilify, aripiprazole
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-000235-PIP02-10-M02, Route(s) of administration: Oral use, Intramuscular use, Pharmaceutical form(s): Tablets, Orodispersible tablet, Oral solution, Solution for injection
Decision date: 26/10/2012, Last updated: 26/11/2012, Compliance check: V, 24/06/2016 -
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Withdrawn application: Abilify
aripiprazole, date of withdrawal: 17/11/2009, Post-authorisation, Last updated: 19/11/2009 -
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Human medicine European public assessment report (EPAR): Abilify Maintena
aripiprazole, Schizophrenia
Date of authorisation: 14/11/2013, Revision: 17, Authorised, Last updated: 16/10/2020 -
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Withdrawn application: Abilify MyCite
aripiprazole, date of withdrawal: 17/07/2020, Initial authorisation, Last updated: 22/10/2020 -
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Human medicine European public assessment report (EPAR): Ablavar (previously Vasovist)
gadofosveset trisodium, Magnetic Resonance Angiography
Date of authorisation: 03/10/2005, Revision: 10, Withdrawn, Last updated: 14/11/2011 -
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Withdrawn application: ABP 710
infliximab, date of withdrawal: 27/05/2019, Initial authorisation, Last updated: 28/06/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Abraxane, paclitaxel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001308-PIP01-12-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for suspension for injection
Decision date: 14/08/2018, Last updated: 19/12/2018, Compliance check: V, 21/09/2018 -
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Human medicine European public assessment report (EPAR): Abraxane
paclitaxel, Breast Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 11/01/2008, Revision: 26, Authorised, Last updated: 09/03/2020 -
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Human medicine European public assessment report (EPAR): Abseamed
epoetin alfa, Anemia, Kidney Failure, Chronic, Cancer
Date of authorisation: 27/08/2007,
Date of refusal: 18/06/2009,, Revision: 22, Authorised, Last updated: 08/10/2019
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Herbal medicinal product: Absinthii herba
Artemisia absinthium L., Wormwood, F: Assessment finalised, Last updated: 08/04/2020 -
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Human medicine European public assessment report (EPAR): Accofil
filgrastim, Neutropenia
Date of authorisation: 17/09/2014,, Revision: 11, Authorised, Last updated: 24/08/2020
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Opinion/decision on a Paediatric investigation plan (PIP): Aclasta, zoledronic acid
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000057-PIP01-07-M07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 17/01/2020, Last updated: 11/06/2020, Compliance check: X -
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Human medicine European public assessment report (EPAR): Aclasta
zoledronic acid, Osteoporosis, Osteitis Deformans, Osteoporosis, Postmenopausal
Date of authorisation: 15/04/2005, Revision: 27, Authorised, Last updated: 12/06/2020 -
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Human medicine European public assessment report (EPAR): Acomplia
rimonabant, Obesity
Date of authorisation: 19/06/2006, Revision: 8, Withdrawn, Last updated: 30/01/2009 -
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Human medicine European public assessment report (EPAR): Acrescent
memantine hydrochloride, donepezil hydrochloride, Alzheimer Disease
Date of refusal: 20/02/2013, Refused, Last updated: 11/03/2013 -
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Human medicine European public assessment report (EPAR): Actelsar HCT (updated)
telmisartan, hydrochlorothiazide, Essential Hypertension
Date of authorisation: 13/03/2013,
, Revision: 11, Authorised, Last updated: 23/11/2020
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Veterinary medicine European public assessment report (EPAR): Acticam
meloxicam, Dogs, Cats
Date of authorisation: 09/12/2008,, Revision: 8, Authorised, Last updated: 12/05/2020
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Referral: Actilyse
Alteplase, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 27/06/2002, EC decision date: 30/09/2002, Last updated: 25/01/2006 -
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Referral: Actira
moxifloxacin, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 20/03/2008, EC decision date: 14/07/2008, Last updated: 13/10/2008 -
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Referral: Activelle
estradiol and norethisterone acetate, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 26/06/2008, EC decision date: 11/09/2008, Last updated: 25/09/2008 -
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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 (updated)
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: 25, Authorised, Last updated: 07/06/2016