126 results
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Opinion/decision on a Paediatric investigation plan (PIP): purified diphtheria toxoid, Purified Tetanus Toxoid, Five component acellular pertussis [Purified Pertussis Toxoid (PT), Purified Filamentous Haemagglutinin (FHA), Purified Fimbriae Types 2 and 3 (FIM), and Purified Pertactin (PRN)], Inactivated poliomyelitis vaccine (Vero) – Type 1 (Mahoney), Type 2 (MEF-1) and Type 3 (Saukett), Purified polyribosylribitol phosphate capsular polysaccharide of Haemophilus influenzae type b covalently bound to Tetanus protein (PRP-T)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Vaccines
PIP number: EMEA-000278-PIP01-08-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection in pre-filled syringe, Suspension for injection in a vial
Decision date: 31/03/2009, Last updated: 18/05/2009, Compliance check: V, 18/09/2009polyribosylribitol phosphate capsular polysaccharide of Haemophilus … polyribosylribitol phosphate capsular polysaccharide of Haemophilus … polyribosylribitol phosphate capsular polysaccharide of Haemophilus … -
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Human medicine European public assessment report (EPAR): Nimenrix
Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal
Date of authorisation: 20/04/2012, Revision: 35, Authorised, Last updated: 25/05/2022contains small amounts of capsular polysaccharides (sugars from … -
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Referral: Cyklo-f
tranexamic acid, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/05/2000, EC decision date: 12/09/2000, Last updated: 27/07/2000Cyklo-f is supplied as white, capsular film coated tablets containing … 1999. Cyklo-f is supplied as white, capsular film coated tablets containing … -
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National expert: Kai-Uwe Riedel, Medical Products Agency (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 28.05 KB | PDF
electrons to Rhodobacter capsulatus nitrogenase. Eur.J.Biochem … purple bacterium Rhodobacter capsulatus. J Mol Microbiol Biotechnol … fixation in Rhodobacter capsulatus: identification of new anf … -
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National expert: Angela Del Vecchio, Italian Medicines Agency (updated)
- Declaration of interests - 40.11 KB | PDF
- Curriculum Vitae - 28.3 KB | PDF
Vecchio A. Le Procedure per il rilascio dell’esenzione dagli accertamenti … -
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National expert: Andreas Sundgren, Norwegian Medicines Agency (updated)
- Declaration of interests - 39.2 KB | PDF
- Curriculum Vitae - 28.54 KB | PDF
Streptococcus pneumoniae Type 14 Capsular Polysaccharide Structures … -
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National expert: Anne-Mette Hoberg, Danish Medicines Agency (updated)
- Declaration of interests - 39.42 KB | PDF
- Curriculum Vitae - 28.87 KB | PDF
preparations from Methylococcus capsulatus (Bath) comprise methanol … -
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National expert: Svein Rune Andersen, European Medicines Agency (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 27.64 KB | PDF
A. Staphylococcus aureus capsular polysaccharide type 5 conjugate … -
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Human medicine European public assessment report (EPAR): Vaxneuvance (updated)
pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections
Date of authorisation: 13/12/2021,
, Revision: 4, Authorised, Last updated: 12/05/2023
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Human medicine European public assessment report (EPAR): Infanrix Hexa (updated)
Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), hepatitis B surface antigen, poliovirus (inactivated) (type-1 (Mahoney strain), type-2 (MEF-1 strain), type-3 (Saukett strain)), Haemophilus influenzae type b polysaccharide, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Date of authorisation: 23/10/2000, Revision: 46, Authorised, Last updated: 24/05/2023Haemophilus influenzae type b (Hib) capsular polysaccharide and Tetanus … -
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Human medicine European public assessment report (EPAR): Bexsero (updated)
outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254), recombinant Neisseria meningitidis group B fHbp fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B NHBA fusion protein, Meningitis, Meningococcal
Date of authorisation: 13/01/2013, Revision: 32, Authorised, Last updated: 23/05/2023 -
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Human medicine European public assessment report (EPAR): Apexxnar
Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 8, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 10A, Pneumococcal polysaccharide serotype 11A, Pneumococcal polysaccharide serotype 12F, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 15b, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 22F, Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 33F, Pneumococcal Infections
Date of authorisation: 14/02/2022,, Revision: 4, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Menveo
meningococcal group A, C, W-135 and Y conjugate vaccine, Immunization; Meningitis, Meningococcal
Date of authorisation: 15/03/2010,
Date of refusal: 17/12/2009, Revision: 32, Authorised, Last updated: 30/01/2023 -
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National expert: Federica Chiara, European Medicines Agency (updated)
- Declaration of interests - 40.45 KB | PDF
- Curriculum Vitae - 206.71 KB | PDF
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Human medicine European public assessment report (EPAR): MenQuadfi
Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal
Date of authorisation: 18/11/2020,, Revision: 8, Authorised, Last updated: 01/03/2023
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Human medicine European public assessment report (EPAR): Prevenar 13
Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F, Pneumococcal Infections; Immunization
Date of authorisation: 09/12/2009, Revision: 43, Authorised, Last updated: 15/02/2023 -
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Human medicine European public assessment report (EPAR): Celdoxome pegylated liposomal
doxorubicin hydrochloride, Breast Neoplasms; Ovarian Neoplasms; Multiple Myeloma; Sarcoma, Kaposi
Date of authorisation: 15/09/2022, Revision: 1, Authorised, Last updated: 13/04/2023 -
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Human medicine European public assessment report (EPAR): Vaxelis
Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3, hepatitis B surface antigen produced in yeast cells, poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein., Meningitis, Haemophilus; Poliomyelitis; Tetanus; Diphtheria; Whooping Cough; Hepatitis B
Date of authorisation: 15/02/2016, Revision: 14, Authorised, Last updated: 20/02/2023 -
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Human medicine European public assessment report (EPAR): Enjaymo
sutimlimab, Hemolysis; Anemia, Hemolytic, Autoimmune
Date of authorisation: 15/11/2022,, 
, Revision: 2, Authorised, Last updated: 13/04/2023
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Human medicine European public assessment report (EPAR): Vfend
voriconazole, Candidiasis; Mycoses; Aspergillosis
Date of authorisation: 19/03/2002, Revision: 52, Authorised, Last updated: 13/02/2023 -
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Human medicine European public assessment report (EPAR): Circadin (updated)
melatonin, Sleep Initiation and Maintenance Disorders
Date of authorisation: 29/06/2007, Revision: 34, Authorised, Last updated: 17/05/2023 -
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Human medicine European public assessment report (EPAR): Synflorix (updated)
Pneumococcal polysaccharide serotype 23F, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19F, Pneumococcal Infections; Immunization
Date of authorisation: 29/03/2009, Revision: 36, Authorised, Last updated: 24/05/2023 -
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Human medicine European public assessment report (EPAR): Trumenba
Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B, Meningitis, Meningococcal
Date of authorisation: 24/05/2017, Revision: 14, Authorised, Last updated: 02/12/2022 -
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Human medicine European public assessment report (EPAR): Zolsketil pegylated liposomal (updated)
doxorubicin hydrochloride, liposomal, Ovarian Neoplasms; Sarcoma, Kaposi; Multiple Myeloma
Date of authorisation: 31/05/2022, Revision: 1, Authorised, Last updated: 04/05/2023 -
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Human medicine European public assessment report (EPAR): Zolgensma
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,, , 
, Revision: 10, Authorised, Last updated: 17/03/2023