134 results
Keyword Urorec - Capsula Remove keyword
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National expert: Cristina Pezzella, Italian Medicines Agency (updated)
- Declaration of interests - 39.33 KB | PDF
- Curriculum Vitae - 53.36 KB | PDF
immunochemistry of streptococcal capsular structures, mechanism of … -
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Veterinary medicine European public assessment report (EPAR): Startvac
Escherichia coli J5 inactivated, Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime-associated antigenic complex, Cattle (cows and heifers)
Date of authorisation: 11/02/2009, Revision: 3, Authorised, Last updated: 07/05/2018 -
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Human medicine European public assessment report (EPAR): Procomvax
polyribosylribitol phosphate from Haemophilus influenzae type b as PRP-OMPC, outer membrane protein complex of Neisseria meningitidis (outer membrane protein complex of the B11 strain of Neisseria meningitidis subgroup B), adsorbed hepatitis B surface antigen produced in recombinant yeast cells (Saccharomyces cerevisiae), Hepatitis B; Meningitis, Haemophilus; Immunization
Date of authorisation: 07/05/1999, Revision: 9, Withdrawn, Last updated: 29/07/2009 -
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Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,
, Revision: 26, Authorised, Last updated: 06/12/2022
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Human medicine European public assessment report (EPAR): Hexavac
purified diphtheria toxoid, Purified Tetanus Toxoid, purified pertussis toxoid, purified pertussis filamentous haemagglutinin, hepatitis B surface antigen, Inactivated Type 1 Poliovirus (Mahoney), inactivated type 2 poliovirus (MEF 1), Inactivated Type 3 Poliovirus (Saukett), Haemophilus influenzae type b polysaccharide, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Date of authorisation: 23/10/2000, Withdrawn, Last updated: 16/08/2012 -
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Human medicine European public assessment report (EPAR): Maci
autologous cultured chondrocytes, Fractures, Cartilage
Date of authorisation: 27/06/2013,
Date of refusal: 26/04/2013, Revision: 4, Withdrawn, Last updated: 05/07/2018 -
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Human medicine European public assessment report (EPAR): Humira
adalimumab, Spondylitis, Ankylosing; Arthritis, Juvenile Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 08/09/2003, Revision: 89, Authorised, Last updated: 16/12/2022 -
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Human medicine European public assessment report (EPAR): Nerventra
laquinimod, Multiple Sclerosis
Date of refusal: 19/08/2014, Refused, Last updated: 01/09/2014 -
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Human medicine European public assessment report (EPAR): Parareg
cinacalcet, Hypercalcemia; Parathyroid Neoplasms; Hyperparathyroidism
Date of authorisation: 22/10/2004, Revision: 6, Withdrawn, Last updated: 14/05/2009 -
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National expert: Fabrizio Chiodo, European Medicines Agency (updated)
- Declaration of interests - 39.74 KB | PDF
- Curriculum Vitae - 49.18 KB | PDF
synthetic epitopes between the capsular polysaccharides from Streptococcus … -
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Withdrawn application: Retisert
date of withdrawal: 16/07/2007, Initial authorisation, Last updated: 23/07/2007 -
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Withdrawn application: Arxxant
date of withdrawal: 13/03/2007, Initial authorisation, Last updated: 15/03/2007 -
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Withdrawn application: Faldaprevir Boehringer Ingelheim
date of withdrawal: 10/06/2014, Initial authorisation, Last updated: 16/09/2014 -
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Referral: Synapse (updated)
Article 31 referrals
Status: Procedure started, Last updated: 07/09/2023 -
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Referral: GVK Biosciences
esomeprazole magnesium, candesartan cilexetil, nebivolol, desloratadine, donepezil, repaglinide, candesartan, esomeprazole, alendronic acid, ropinirole, cefpodoxime, quetiapine, trimetazidine, bosentan, tramadol, paracetamol, escitalopram, trimetazidine hydrochloride, entacapone, valsartan, hydrochlorothiazide, donepezil hydrochloride, ropinirole hydrochloride, clopidogrel hydrochloride, escitalopram oxalate, metformin hydrochloride, trimetazidine dihydrochloride, rizatriptan benzoate, metformin, fluconazole, eletriptan, rizatriptan, ebastine, ibuprofen, desmopressin, aciclovir, levetiracetam, irbesartan, venlafaxine, ciprofloxacin, cefpodoxime proxetil, tacrolimus, fexofenadine hydrochloride, phenoxymethylpenicillin, amlodipine besilate, metoclopramide, clopidogrel, levodopa, carbidopa, entacapone, atorvastatin, telmisartan, clindamycin hydrochloride, metoclopramide hydrochloride, clonazepam, clobazam, dexamethasone, thiamine hydrochloride, tramadol hydrochloride, pioglitazone, dipyridamole, fexofenadine, amlodipine, pantoprazole, hydrocortisone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/05/2015, EC decision date: 16/07/2015, Last updated: 04/08/2015 -
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Referral: Stamaril
live attenuated yellow fever virus, Article 30 referrals
Status: European Commission final decision, opinion/position date: 27/04/2006, EC decision date: 04/07/2006, Last updated: 14/07/2006 -
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Referral: Menitorix
Haemophilus type b and Meningococcal group C conjugate vaccine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 16/11/2007, EC decision date: 01/04/2008, Last updated: 18/04/2008purified H. influenzae type b capsular polysaccharide, polyribosylribitol … 5µg of the meningococcal capsular polysaccharide of group … -
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Referral: Isotretinoin
isotretinoin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 16/12/2010, EC decision date: 18/05/2011, Last updated: 15/07/2011 -
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Referral: Ibuprofen- and dexibuprofen-containing medicines
ibuprofen, dexibuprofen, Article 31 referrals
Status: CMDh final position, opinion/position date: 20/05/2015, Last updated: 14/07/2015 -
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Referral: Diflucan
fluconazole, associated names: Fluconazole, Fungustatin, Fungata, Triflucan, Article 30 referrals
Status: European Commission final decision, opinion/position date: 23/06/2011, EC decision date: 02/09/2011, Last updated: 02/02/2012 -
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Referral: Valebo and associated names
alendronic acid, alfacalcidol, associated names: Tevabone, Teboneva, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/12/2013, EC decision date: 10/03/2014, Last updated: 31/03/2014mg comprimidos y 1 mcg capsulas blandas 70 mg And 1 … -
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Referral: Norfloxacin
norfloxacin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/07/2008, EC decision date: 19/11/2008, Last updated: 24/07/2008 -
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Opinion on medicine for use outside EU: Globorix
Diphtheria toxoid, Tetanus toxoid, Bordetella pertussis (inactivated), Haemophilus influenzae type b polysaccharide, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, hepatitis B surface antigen, Immunization; Hepatitis B; Diphtheria-Tetanus-Pertussis Vaccine; Bordetella pertussis; Haemophilus influenzae type b; Neisseria meningitidis, Serogroup A; Neisseria meningitidis, Serogroup C, ATC code: J07CA09 Opinion number: H/W/848, Withdrawn application , Last updated: 05/07/2018 -
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Referral: Arimidex
anastrozole, Article 29 paediatrics
Status: European Commission final decision, EC decision date: 06/11/2009, Last updated: 28/05/2010 -
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Referral: Ergot-derived dopamine agonists
bromocriptine, cabergoline, dihydroergocryptine, lisuride, pergolide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/06/2008, Last updated: 26/06/2008