67 results
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Direct healthcare professional communications
Last updated: 14/02/2020 -
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Human medicine European public assessment report (EPAR): Fampyra
Fampridine, Multiple Sclerosis
Date of authorisation: 20/07/2011, Revision: 14, Authorised, Last updated: 24/08/2020 -
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Human medicine European public assessment report (EPAR): Cinryze
C1 inhibitor (human), Angioedemas, Hereditary
Date of authorisation: 15/06/2011,
, Revision: 19, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Bavencio
avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017,, Revision: 8, Authorised, Last updated: 11/02/2021
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Human medicine European public assessment report (EPAR): Livogiva
teriparatide, Osteoporosis
Date of authorisation: 27/08/2020,, 
, Revision: 1, Authorised, Last updated: 07/01/2021
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Human medicine European public assessment report (EPAR): Tysabri (updated)
natalizumab, Multiple Sclerosis
Date of authorisation: 27/06/2006, Revision: 33, Authorised, Last updated: 06/04/2021 -
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Human medicine European public assessment report (EPAR): Brintellix
Vortioxetine, Depressive Disorder, Major
Date of authorisation: 18/12/2013, Revision: 16, Authorised, Last updated: 15/01/2021 -
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Human medicine European public assessment report (EPAR): Qutavina
teriparatide, Osteoporosis
Date of authorisation: 27/08/2020,, Withdrawn, Last updated: 18/01/2021
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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, Revision: 13, Withdrawn, Last updated: 21/02/2012
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Withdrawn application: Aranesp
darbepoetin alfa, date of withdrawal: 21/02/2018, Post-authorisation, Last updated: 24/04/2018 -
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Herbal medicinal product: Polypodii rhizoma
Polypodium vulgare L., Polypody Rhizome, F: Assessment finalised, Last updated: 22/08/2019 -
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Herbal medicinal product: Equiseti herba
Equisetum arvense L., Horsetail herb, F: Assessment finalised, Last updated: 28/04/2016 -
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Combination Herbal medicinal product: Species diureticae
Combination: maximum 4 out of 13 possible plants, Diuretic herbal tea combinations, F: Assessment finalised, Last updated: 21/07/2017 -
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Referral: Zyrtec
cetirizine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 30/05/2008, EC decision date: 06/10/2008, Last updated: 16/10/2008 -
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Referral: Vivaglobin
human normal immunoglobulin, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 16/02/2012, EC decision date: 07/05/2012, Last updated: 18/11/2013160 mg/ml para inyección (uso subcutáneo) 160mg/ml … -
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Orphan designation: Dexamethasone phosphate for: Treatment of corneal graft rejection
Date of first decision: 15/05/2009, Withdrawn, Last updated: 21/10/2016 -
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Referral: Baxter dialysis solutions
Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/10/2011, EC decision date: 16/12/2011, Last updated: 20/11/2013 -
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Referral: Ciprofloxacin Hikma
ciprofloxacin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/01/2007, EC decision date: 11/06/2007, Last updated: 06/09/2007Ciprofloxacin Hikma 200mg/100ml Soluzione per Infusione Endovenosa … -
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Referral: Fibrates
bezafibrate, ciprofibrate, fenofibrate, gemfibrozil, associated names: Bezalip, Lipanor, Lipanthyl, Lopid, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/10/2010, EC decision date: 28/02/2011, Last updated: 03/04/2013 -
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Referral: Priorix
measles, mumps and rubella vaccine (live), Article 30 referrals
Status: European Commission final decision, opinion/position date: 15/03/2012, EC decision date: 25/05/2012, Last updated: 19/06/2012 -
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Referral: Bleomycin
bleomycin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/12/2008, EC decision date: 12/03/2009, Last updated: 31/03/2009 -
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Referral: Losec
omeprazole, associated names: Antra, Logastric, Losec Forte, Mopral, Omeprazen, Omeprazole, AstraZeneca, Zoltum, Article 30 referrals
Status: European Commission final decision, opinion/position date: 20/01/2010, EC decision date: 10/06/2010, Last updated: 19/09/2011 -
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Referral: Serotonin-specific reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors
atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 19/08/2005, Last updated: 03/11/2005 -
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Orphan designation: Alpha-1 proteinase inhibitor for: Treatment of cystic fibrosis
Date of first decision: 14/09/2007, Withdrawn, Last updated: 08/12/2020 -
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Orphan designation: Beclomethasone 17, 21-dipropionate for: Treatment of intestinal graft-versus-host disease
Date of first decision: 13/03/2002, Positive, Last updated: 08/06/2020