8297 results
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Human medicine European public assessment report (EPAR): Ravicti (updated)
glycerol phenylbutyrate, Urea Cycle Disorders, Inborn
Date of authorisation: 26/11/2015, Additional monitoring, Revision: 9, Authorised -
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Human medicine European public assessment report (EPAR): Trobalt (updated)
retigabine, Epilepsy
Date of authorisation: 27/03/2011, Revision: 12, Withdrawn -
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Human medicine European public assessment report (EPAR): Esmya (updated)
ulipristal, Leiomyoma
Date of authorisation: 22/02/2012, Revision: 14, Authorised -
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Human medicine European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene) (updated)
pomalidomide, Multiple Myeloma
Date of authorisation: 04/08/2013, Additional monitoring, Revision: 13, Authorised -
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Human medicine European public assessment report (EPAR): Viread (updated)
tenofovir disoproxil, Hepatitis B, Chronic HIV Infections
Date of authorisation: 04/02/2002, Revision: 50, Authorised -
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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, Additional monitoring, Biosimilar, Revision: 7, Authorised -
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Human medicine European public assessment report (EPAR): Pramipexole Accord (updated)
pramipexole, Parkinson Disease Restless Legs Syndrome
Date of authorisation: 29/09/2011, Generic, Revision: 7, Authorised -
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Human medicine European public assessment report (EPAR): Remicade (updated)
infliximab, Spondylitis, Ankylosing Arthritis, Rheumatoid Psoriasis Crohn Disease Arthritis, Psoriatic Colitis, Ulcerative
Date of authorisation: 13/08/1999, Revision: 51, Authorised -
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Human medicine European public assessment report (EPAR): Orbactiv (updated)
oritavancin, Soft Tissue Infections Skin Diseases, Bacterial
Date of authorisation: 18/03/2015, Additional monitoring, Revision: 4, Authorised -
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Human medicine European public assessment report (EPAR): Tresiba (updated)
insulin degludec, Diabetes Mellitus
Date of authorisation: 20/01/2013, Revision: 11, Authorised -
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Human medicine European public assessment report (EPAR): Fertavid (updated)
follitropin beta, Infertility Hypogonadism
Date of authorisation: 19/03/2009, Revision: 11, Authorised -
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Human medicine European public assessment report (EPAR): Pemetrexed medac (updated)
pemetrexed, Carcinoma, Non-Small-Cell Lung Mesothelioma
Date of authorisation: 26/11/2015, Generic, Revision: 3, Authorised -
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Human medicine European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals) (updated)
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted), Influenza, Human Immunization Disease Outbreaks
Date of authorisation: 10/10/2009, Exceptional circumstances, Revision: 9, Authorised -
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Human medicine European public assessment report (EPAR): Caprelsa (updated)
vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012, Additional monitoring, Conditional approval, Revision: 13, Authorised -
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Human medicine European public assessment report (EPAR): Invirase (updated)
saquinavir, HIV Infections
Date of authorisation: 03/10/1996, Revision: 46, Authorised -
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Human medicine European public assessment report (EPAR): Trizivir (updated)
abacavir (as sulfate) / lamivudine / zidovudine, HIV Infections
Date of authorisation: 27/12/2000, Revision: 32, Authorised -
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Human medicine European public assessment report (EPAR): Isentress (updated)
raltegravir, HIV Infections
Date of authorisation: 19/12/2007, Revision: 34, Authorised -
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Veterinary medicine European public assessment report (EPAR): Aftovaxpur DOE (updated)
Foot-and-mouth disease vaccine (inactivated) (multistrain: 1-3 strains out of set of 8), Pigs Cattle Sheep
Date of authorisation: 15/07/2013, Revision: 5, Authorised -
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Veterinary medicine European public assessment report (EPAR): Clynav (updated)
Salmon pancreas disease vaccine (recombinant DNA plasmid), Atlantic salmon
Date of authorisation: 26/06/2017, Revision: 3, Authorised -
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Human medicine European public assessment report (EPAR): Exelon (updated)
rivastigmine, Dementia Alzheimer Disease Parkinson Disease
Date of authorisation: 11/05/1998, Revision: 37, Authorised -
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Human medicine European public assessment report (EPAR): Puregon (updated)
follitropin beta, Infertility Hypogonadism
Date of authorisation: 02/05/1996, Revision: 26, Authorised -
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Human medicine European public assessment report (EPAR): Entecavir Accord (updated)
entecavir, Hepatitis B, Chronic
Date of authorisation: 25/09/2017, Generic, Revision: 1, Authorised -
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Human medicine European public assessment report (EPAR): Somavert (updated)
pegvisomant, Acromegaly
Date of authorisation: 12/11/2002, Revision: 19, Authorised -
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Human medicine European public assessment report (EPAR): Hefiya (updated)
adalimumab, Hidradenitis Suppurativa Spondylitis, Ankylosing Psoriasis Arthritis, Juvenile Rheumatoid Uveitis
Date of authorisation: 25/07/2018, Additional monitoring, Biosimilar, Revision: 1, Authorised -
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Human medicine European public assessment report (EPAR): Deltyba (updated)
delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014, Additional monitoring, Conditional approval, Revision: 10, Authorised