19580 results
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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: 24/05/2023Infanrix Hexa Infections Communicable Diseases Blood-Borne … icable Diseases Blood-Borne Infections Virus Diseases DNA Virus Infections Hepadnaviridae … diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa … -
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Human medicine European public assessment report (EPAR): Infanrix HepB
Diphtheria toxoid, tetanus toxoid, pertussis toxoid, pertussis haemagglutin filamentous, pertactin, hepatitis B recombinant surface antigen, Hepatitis B; Tetanus; Immunization; Whooping Cough; Diphtheria
Date of authorisation: 30/07/1997, Revision: 3, Withdrawn, Last updated: 04/08/2005Infanrix HepB Hepatitis B Tetanus Immunization Whooping … diphtheria, tetanus, acellular pertussis and hepatitis B recombinant … marketing authorisation for Infanrix HepB has been withdrawn at … -
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Human medicine European public assessment report (EPAR): Quintanrix
Diphtheria toxoid, tetanus toxoid, inactivated Bordetella pertussis, hepatitis B surface antigen (rDNA), Haemophilus influenzae type b polysaccharide, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Diphtheria
Date of authorisation: 17/02/2005, Revision: 2, Withdrawn, Last updated: 10/09/2008thdrawn diphtheria, tetanus, pertussis (whole cell), hepatitis B … B (rDNA) and Haemophilus influenzae type B conjugate vaccine … toxoidinactivated Bordetella pertussishepatitis B surface antigen (rDNA)Haemophilus … -
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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: 16/08/2012diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis … recombinant) and Haemophilus influenzae type b conjugate vaccine … toxoidPurified Tetanus Toxoidpurified pertussis toxoidpurified … -
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Human medicine European public assessment report (EPAR): Hexacima
hepatitis B surface antigen, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin, poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett), Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 28, Authorised, Last updated: 22/03/2023Hexacima Infections Communicable Diseases Blood-Borne … icable Diseases Blood-Borne Infections Virus Diseases DNA Virus Infections Hepadnaviridae Infections Hepatitis, Viral, Human Digestive … horised diphtheria, tetanus, pertussis (acellular, component), hepatitis … -
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Human medicine European public assessment report (EPAR): Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited)
pemetrexed ditromethamine, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 24/04/2017,
, Revision: 7, Withdrawn, Last updated: 29/07/2021
as Pemetrexed Hospira UK Limited) Carcinoma, Non-Small-Cell … as Pemetrexed Hospira UK Limited) Agency product number EMEA/H/C/004488 … same disease(s). For more information, see Generic and hybrid medicines … -
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Opinion on medicine for use outside EU: Hexaxim
Diphtheria toxoid, Tetanus toxoid, Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin, Inactivated poliovirus: type 1 (Mahoney strain), Inactivated poliovirus: type 2 (MEF-1 strain), Inactivated poliovirus: type 3 (Saukett strain), hepatitis B surface antigen, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria, ATC code: J07CA09 Opinion number: H-W-2495, Withdrawn opinion Opinion date: 21/06/2012, Last updated: 06/07/2018diphtheria, tetanus, pertussis (acellular, component), hepatitis … inactivated) and Haemophilus influenzae type b conjugate vaccine … Hexaxim Diphtheria, tetanus, pertussis (acellular, component), hepatitis … -
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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: 20/02/2023Vaxelis Infections Bacterial Infections and Mycoses Bacterial Infections Central Nervous System Bacterial … horised diphtheria, tetanus, pertussis (acellular, component), hepatitis … and including the product information, published on the European … -
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Human medicine European public assessment report (EPAR): Infanrix Penta
Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens (pertussis toxoid, filamentous haemagglutinin, pertactin), poliovirus (inactivated) (type 1 (Mahoney strain), type 2 (MEF-1 strain), type 3 (Saukett strain)), hepatitis B surface antigen, Hepatitis B; Tetanus; Immunization; Whooping Cough; Poliomyelitis; Diphtheria
Date of authorisation: 23/10/2000, Revision: 13, Withdrawn, Last updated: 23/08/2013Infanrix Penta Hepatitis B Tetanus Immunization Whooping … diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa … marketing authorisation for Infanrix Penta has lapsed because … -
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Human medicine European public assessment report (EPAR): Hexyon
filamentous haemagglutinin, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), hepatitis B surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells, poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells, poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, Diphtheria toxoid, Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Date of authorisation: 17/04/2013,
Date of refusal: 22/02/2013, Revision: 29, Authorised, Last updated: 22/03/2023Hexyon Infections Communicable Diseases Blood-Borne … icable Diseases Blood-Borne Infections Virus Diseases DNA Virus Infections Hepadnaviridae Infections Hepatitis, Viral, Human Digestive … horised diphtheria, tetanus, pertussis (acellular, component), hepatitis … -
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Human medicine European public assessment report (EPAR): Sunosi
solriamfetol hydrochloride, Narcolepsy; Sleep Apnea, Obstructive
Date of authorisation: 16/01/2020,
, Revision: 7, Authorised, Last updated: 14/12/2022
Authorised solriamfetol Overview Sunosi is a medicine … medicine. active substance solriamfetol. How is Sunosi used? Sunosi … 150 mg once a day. For more information about using Sunosi, see the … -
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Opinion/decision on a Paediatric investigation plan (PIP): Alpivab, Peramivir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001856-PIP02-16-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 07/07/2021, Last updated: 09/03/2023, Compliance check: V, 17/12/2021EMEA-001856-PIP02-16-M02 Infectious diseases … Key facts Alpivab Peramivir Infectious diseasesP/0257/2021EMEA-001856-PIP02-16-M02 … diseasesP/0257/2021EMEA-001856-PIP02-16-M02 Concentrate for solution for infusion Treatment of … -
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Human medicine European public assessment report (EPAR): Taxespira (previously Docetaxel Hospira UK Limited )
docetaxel trihydrate, Stomach Neoplasms; Prostatic Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 28/08/2015,, Revision: 8, Withdrawn, Last updated: 15/10/2019
previously Docetaxel Hospira UK Limited ) Stomach Neoplasms Prostatic … previously Docetaxel Hospira UK Limited ) Agency product number EMEA/H/C/003925 … same disease(s). For more information, see Generic and hybrid medicines … -
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Opinion/decision on a Paediatric investigation plan (PIP): Optaflu, Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145); A/Wisconsin/67/2005 (H3N2)-like strain (A/Wisconsin/67/2005, NYMC X161B); B/Malaysia/2506/2004-like strain (B/Malaysia/2506/2004)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000124-PIP01-07-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection in pre-filled syringe
Decision date: 28/09/2012, Last updated: 27/02/2019, Compliance check: XKey facts Optaflu Influenza virus surface antigens (haemagglutinin … the following strains: A/Solomon Islands/3/2006 (H1N1)-like … Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145); A/Wisconsin/67/2005 … -
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Orphan designation: Cultured allogeneic corneal limbal stem cells for: Treatment of limbal stem cell deficiency
Date of designation: 15/10/2014, Positive, Last updated: 12/11/2014cultured allogeneic corneal limbal stem cells for the treatment … cells for the treatment of limbal stem cell deficiency. Expand … Collapse section What is limbal stem cell deficiency … -
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Human medicine European public assessment report (EPAR): Alpivab
Peramivir, Influenza, Human
Date of authorisation: 13/04/2018,, Revision: 2, Withdrawn, Last updated: 09/12/2020
Alpivab Influenza, Human … EMEA/H/C/004299 Active substance Peramivir International non-proprietary … name (INN) or common name peramivir Therapeutic area (MeSH Influenza, Human Anatomical therapeutic … -
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Herbal medicinal product: Tiliae tomentosae flos
Tilia tomentosa Moench, Silver lime flower, F: Assessment finalised, Last updated: 09/07/2012Abbreviated as HMPC. More information can be found under 'Committee … herbal medicines. More information can be found under Committee … herbal preparation. More information is available under 'European … -
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Opinion/decision on a Paediatric investigation plan (PIP): Solithromycin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001581-PIP02-16, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Capsule, hard, Powder for concentrate for solution for infusion, Powder for oral suspension
Decision date: 28/04/2016, Last updated: 20/04/2018, Compliance check: XEMEA-001581-PIP02-16 Infectious diseases … Key facts Solithromycin Infectious diseasesP/0120/2016EMEA-001581-PIP02-16 … Powder for concentrate for solution for infusion Powder for oral suspension … -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous tumour-derived immunoglobulin idiotype coupled to keyhole limpet hemocyanin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001274-PIP01-12, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 20/08/2012, Last updated: 17/09/2012, Compliance check: Xidiotype coupled to keyhole limpet hemocyanin Therapeutic area … EMEA-001274-PIP01-12 Pharmaceutical form(s) Solution for injection Condition(s … idiotype coupled to keyhole limpet haemocyanin (EMEA-001274-PIP01-12) 7 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Solithromycin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001581-PIP01-13-M03, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Capsule, hard, Powder for concentrate for solution for infusion, Powder for oral suspension
Decision date: 15/07/2016, Last updated: 20/04/2018, Compliance check: XEMEA-001581-PIP01-13-M03 Infectious diseases … Key facts Solithromycin Infectious diseasesP/0180/2016EMEA-001581-PIP01-13-M03 … Powder for concentrate for solution for infusion Powder for oral suspension … -
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Withdrawn application: Solithromycin Triskel EU Services
date of withdrawal: 27/03/2017, Initial authorisation, Last updated: 02/06/2017Solithromycin Triskel EU Services: Withdrawn … authorisation application for Solithromycin Triskel EU Services solithromycin) On 27 March 2017, Triskel … marketing authorisation for Solithromycin Triskel EU Services, intended … -
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Opinion/decision on a Paediatric investigation plan (PIP): Solifenacin (succinate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-000573-PIP01-09-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Film-coated tablet
Decision date: 29/09/2014, Last updated: 27/07/2015, Compliance check: V, 22/05/2015Key facts Solifenacin (succinate) Uro-nephrologyP/0260/2014EMEA-000573-PIP01-09-M05 … paediatric investigation plan for solifenacin (succinate) (Vesicare and … paediatric investigation plan for solifenacin (succinate) (Vesicare and … -
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Referral: Doxyfar 50%
doxycycline hyclate, associated names: Soludox 500 mg/g, Soludox Vet, Soludox 433 mg/g, Doxy Ort 50%, Article 34
Status: European Commission final decision, opinion/position date: 04/05/2011, EC decision date: 13/07/2011, Last updated: 24/08/2011the treatment of certain infections of the respiratory tract … administered and withdrawal periods concerning the authorisation … associated names: Background information PDF icon application/pdf … -
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Herbal medicinal product: Tiliae flos
Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne, Lime flower, F: Assessment finalised, Last updated: 15/02/2023currently developing this information. Key facts Tiliae flosLime … for scientific data for the periodic review of the monograph on … herbal medicines. More information can be found under Committee … -
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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, 18/09/2009Five component acellular pertussis [Purified Pertussis Toxoid (PT), Purified Filamentous … and 3 (FIM), and Purified Pertactin (PRN)] Inactivated poliomyelitis … polysaccharide of Haemophilus influenzae type b covalently bound to …