6569 results
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Opinion/decision on a Paediatric investigation plan (PIP): Azithromycin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediatric Intensive Care
PIP number: EMEA-003021-PIP01-21, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Age-appropriate dosage form for parenteral use
Decision date: 08/09/2021, Last updated: 11/01/2023, Compliance check: Xatology-Paediatric Intensive Care … Neonatology-Paediatric Intensive Care Decision number P/0381/2021 … -
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Direct healthcare professional communication (DHPC): Dexmedetomidine: Increased risk of mortality in intensive care unit (ICU) patients ≤65 years
Active substance: dexmedetomidine hydrochloride, DHPC type: Safety signal, Last updated: 16/06/2022of mortality in intensive care unit (ICU) patients ≤65 … of mortality in intensive care unit (ICU) patients ≤65 years … of mortality in intensive care unit (ICU) patients ≤65 … -
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Press release: Boosting care for newborn babies in low-income countries
CHMP, Last updated: 29/04/2016Boosting care for newborn babies in low-income … treatment guidelines for newborn care recommend chlorhexidine for … chlorhexidine for umbilical cord care for home births in regions … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lactobacillus reuteri (IBP-9414)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology; Neonatology-Paediatric Intensive Care; Other
PIP number: EMEA-001895-PIP01-15-M01, Route(s) of administration: Gastroenteral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 11/08/2021, Last updated: 01/09/2022, Compliance check: Xatology-Paediatric Intensive Care Other … Neonatology-Paediatric Intensive Care Other Decision number P/0314/2021 … -
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Opinion/decision on a Paediatric investigation plan (PIP): cefepime, zidebactam
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases; Neonatology-Paediatric Intensive Care; Uro-nephrology
PIP number: EMEA-002892-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 11/08/2021, Last updated: 12/09/2022, Compliance check: Xdiseases Neonatology-Paediatric Intensive Care Uro-nephrology … Neonatology-Paediatric Intensive Care Uro-nephrology Decision number … -
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European Medicines Agency workshop on pharmacogenomics: from science to clinical care
European Medicines Agency, London, UK, from 08/10/2012 to 09/10/2012, Last updated: 21/11/2012from science to clinical care … from science to clinical care PDF icon application/pdf … from science to clinical care - Invitation for expressions … -
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News: EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome
Last updated: 07/06/2021raises awareness of clinical care recommendations to manage … -
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Direct healthcare professional communication (DHPC): Rucaparib (Rubraca® ): interim data from Study CO-338-043 (ARIEL4) show a decrease in overall survival compared to standard of care
Active substance: rucaparib camsylate, DHPC type: Referral - Article 20 procedure, Last updated: 06/05/2022survival compared to standard of care Ovarian Neoplasms … survival compared to standard of care 06/05/2022 Key facts rucaparib … compared to standard of care Dear Healthcare Professional … -
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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: 15/02/2023Techniques Immunologic Techniques Health Care Facilities, Manpower, and … -
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Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 16/10/2009,
, Revision: 8, Authorised, Last updated: 06/02/2023
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Human medicine European public assessment report (EPAR): Synflorix
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: 35, Authorised, Last updated: 30/01/2023Techniques Immunologic Techniques Health Care Facilities, Manpower, and … -
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Human medicine European public assessment report (EPAR): Aflunov
influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 28/11/2010, Revision: 15, Authorised, Last updated: 03/10/2022Services Health Services Health Care Facilities, Manpower, and … reported with Aflunov are carefully evaluated and any necessary … -
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Human medicine European public assessment report (EPAR): RotaTeq
rotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1, Immunization; Rotavirus Infections
Date of authorisation: 26/06/2006, Revision: 34, Authorised, Last updated: 16/08/2022Practice Communicable Disease Control Health Care Facilities, Manpower, and … -
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Human medicine European public assessment report (EPAR): Zostavax
varicella-zoster virus (live, attenuated), Herpes Zoster; Immunization
Date of authorisation: 19/05/2006, Revision: 33, Authorised, Last updated: 01/07/2022Services Health Services Health Care Facilities, Manpower, and … -
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Human medicine European public assessment report (EPAR): Rotarix
human rotavirus, live attenuated, Immunization; Rotavirus Infections
Date of authorisation: 21/02/2006, Revision: 40, Authorised, Last updated: 29/06/2022Practice Communicable Disease Control Health Care Facilities, Manpower, and … -
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Human medicine European public assessment report (EPAR): Dukoral
recombinant cholera toxin B subunit, vibrio cholerae 01, Cholera; Immunization
Date of authorisation: 28/04/2004, Revision: 14, Authorised, Last updated: 06/04/2022Therapy Immunomodulation Immunotherapy Health Care Facilities, Manpower, and … reported with Dukoral are carefully evaluated and any necessary … reported with Dukoral are carefully evaluated and any necessary … -
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Human medicine European public assessment report (EPAR): Foclivia
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 18/10/2009,, Revision: 12, Authorised, Last updated: 06/04/2022
Services Health Services Health Care Facilities, Manpower, and … reported with Foclivia are carefully evaluated and any necessary … -
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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: 30/01/2023Practice Communicable Disease Control Health Care Facilities, Manpower, and … -
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Human medicine European public assessment report (EPAR): M-M-RVaxPro
measles virus Enders’ Edmonston strain (live, attenuated), mumps virus Jeryl Lynn (level B) strain (live, attenuated), rubella virus Wistar RA 27/3 strain (live, attenuated), Rubella; Mumps; Immunization; Measles
Date of authorisation: 05/05/2006, Revision: 30, Authorised, Last updated: 14/07/2022Techniques Immunologic Techniques Health Care Facilities, Manpower, and … there is an outbreak in a day-care centre or the baby is travelling … considered necessary (e.g., day-care, outbreak situations, or … -
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Human medicine European public assessment report (EPAR): ProQuad
virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella, Chickenpox; Rubella; Measles; Mumps; Immunization
Date of authorisation: 05/04/2006, Revision: 31, Authorised, Last updated: 22/07/2022Techniques Immunologic Techniques Health Care Facilities, Manpower, and … risk- to-benefit ratio should be carefully evaluated before considering … -
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Human medicine European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)
split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 10/10/2009,, Revision: 11, Authorised, Last updated: 08/06/2022
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Human medicine European public assessment report (EPAR): Cervarix
human papillomavirus1 type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections; Uterine Cervical Dysplasia; Immunization
Date of authorisation: 20/09/2007, Revision: 38, Authorised, Last updated: 05/05/2022Techniques Immunologic Techniques Health Care Facilities, Manpower, and … -
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Human medicine European public assessment report (EPAR): Ambirix
hepatitis A virus (inactivated), hepatitis B surface antigen, Hepatitis B; Hepatitis A; Immunization
Date of authorisation: 30/08/2002, Revision: 16, Authorised, Last updated: 14/01/2022Techniques Investigative Techniques Health Care Facilities, Manpower, and … -
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Human medicine European public assessment report (EPAR): Twinrix Adult
hepatitis A virus (inactivated), hepatitis B surface antigen, Hepatitis B; Hepatitis A; Immunization
Date of authorisation: 19/09/1996, Revision: 22, Authorised, Last updated: 14/01/2022Techniques Investigative Techniques Health Care Facilities, Manpower, and … -
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Human medicine European public assessment report (EPAR): Twinrix Paediatric
hepatitis A virus (inactivated), hepatitis B surface antigen, Immunization; Hepatitis B; Hepatitis A
Date of authorisation: 10/02/1997, Revision: 22, Authorised, Last updated: 14/01/2022Techniques Investigative Techniques Health Care Facilities, Manpower, and …