14232 results
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Human medicine European public assessment report (EPAR): Pemetrexed Baxter
pemetrexed disodium heptahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 09/12/2022,, Authorised, Last updated: 19/01/2023
Pemetrexed Baxter Carcinoma, Bronchogenic Bronchial … Pemetrexed Baxter … medicine for marketing once the period of ‘exclusivity’ on the … -
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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
demic Influenza Vaccine H5N1 Baxter AG Respiratory Tract Infections Infections Respiratory … CHMP) assessed the studies performed, to reach its recommendations … Pandemic Influenza Vaccine H5N1 Baxter AG? Pandemic Influenza Vaccine … -
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Human medicine European public assessment report (EPAR): Perjeta
pertuzumab, Breast Neoplasms
Date of authorisation: 04/03/2013, Revision: 22, Authorised, Last updated: 09/12/2021Perjeta Skin and Connective Tissue … Perjeta … Perjeta, INN pertuzumab 30 Churchill Place … -
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Veterinary medicine European public assessment report (EPAR): Vectra 3D
dinotefuran, pyriproxyfen, permethrin, Dogs
Date of authorisation: 04/12/2013, Revision: 7, Authorised, Last updated: 21/02/2022Authorised dinotefuran, permethrin, and pyriproxyfen Overview … dinotefuran, pyriproxyfen and permethrin. How is Vectra 3D used? Vectra … insects. Dinotefuran and permethrin are insecticides which kill … -
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Human medicine European public assessment report (EPAR): Triacelluvax
Diphtheria toxoid, haemagglutinin filamentous, pertussis pertactin, pertussis toxin, tetanus toxoid, Immunization; Tetanus; Whooping Cough; Diphtheria
Date of authorisation: 11/01/1999, Withdrawn, Last updated: 03/07/2002rawn diphtheria, tetanus and pertussis (acellular, component) vaccine … toxoidhaemagglutinin filamentouspertussis pertactinpertussis toxintetanus toxoiddiphtheria … toxoiddiphtheria, tetanus and pertussis (acellular, component) vaccine … -
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Human medicine European public assessment report (EPAR): Fycompa
perampanel, Epilepsies, Partial
Date of authorisation: 23/07/2012, Revision: 31, Authorised, Last updated: 24/02/2023Authorised perampanel Overview Fycompa is an epilepsy … medicine. active substance perampanel. How is Fycompa used? Fycompa … start of treatment is 2 mg per day, and if it is well tolerated … -
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Human medicine European public assessment report (EPAR): Luminity
perflutren, Echocardiography
Date of authorisation: 20/09/2006, Revision: 16, Authorised, Last updated: 29/06/2022Authorised perflutren Overview This is a summary … CHMP ) assessed the studies performed, to reach their recommendations … microspheres (tiny bubbles) of perflutren gas as the The substance … -
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Human medicine European public assessment report (EPAR): Optison
perflutren, Echocardiography
Date of authorisation: 17/05/1998, Revision: 19, Authorised, Last updated: 27/06/2022Authorised perflutren Overview This is a summary … CHMP ) assessed the studies performed, to reach its recommendations … human albumin containing perflutren gas as the The substance … -
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Human medicine European public assessment report (EPAR): Phesgo
pertuzumab, trastuzumab, Breast Neoplasms
Date of authorisation: 21/12/2020,, Revision: 3, Authorised, Last updated: 02/03/2022
pertuzumab / trastuzumab … EMEA/H/C/005386 Phesgo (pertuzumab / trastuzumab) An overview … contains the active substances pertuzumab and trastuzumab. For more … -
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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
peramivir … authorisation for Alpivab (peramivir) in the European Union (EU … Commission of its decision to permanently discontinue the marketing … -
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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: 04/08/2005diphtheria, tetanus, acellular pertussis and hepatitis B recombinant … antigendiphtheria, tetanus, acellular pertussis and hepatitis B recombinant … against diphtheria, tetanus, pertussis and hepatitis B. More information … -
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Veterinary medicine European public assessment report (EPAR): Activyl Tick Plus
indoxacarb, permethrin, Dogs
Date of authorisation: 09/01/2012, Revision: 9, Withdrawn, Last updated: 04/10/2022the product has persistent insecticidal The measurement … Activyl Tick Plus (indoxacarb / permethrin) An overview of Activyl Tick … against sand flies (Phlebotomus perniciosus) that is active for up to … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fycompa, perampanel (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000467-PIP01-08-M15, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Oral suspension
Decision date: 03/12/2021, Last updated: 15/03/2023, Compliance check: XKey facts Fycompa perampanel NeurologyP/0521/2021EMEA-000467-PIP01-08-M15 … paediatric investigation plan for perampanel (Fycompa), (EMEA-000467-PIP01-08-M15 … paediatric investigation plan for perampanel (Fycompa), (EMEA-000467-PIP01-08-M15 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Alpivab, Peramivir (updated)
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, 17/12/2021Key facts Alpivab Peramivir Infectious diseasesP/0257/2021EMEA-001856-PIP02-16-M02 … paediatric investigation plan for peramivir (EMEA-001856-PIP02-16-M02 … paediatric investigation plan for peramivir (EMEA- 001856-PIP02-16-M02 … -
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Veterinary medicine European public assessment report (EPAR): Suiseng Diff/A
Clostridioides difficile toxoid A, Clostridioides difficile toxoid B, Clostridium perfringens, type A, alpha toxoid, Pigs
Date of authorisation: 07/12/2021, Authorised, Last updated: 24/01/2022ides difficile / clostridium perfringens vaccine, inactivated … difficile and Clostridium perfringens vaccine, inactivated) An … A and B) and Clostridium perfringens type A (alpha toxin). Suiseng … -
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Veterinary medicine European public assessment report (EPAR): Enteroporc Coli AC
CLOSTRIDIUM PERFRINGENS TYPE C, BETA1 TOXOID / Clostridium perfringens, type A, alpha toxoid / Clostridium perfringens, type A, beta2 toxoid / Escherichia coli, fimbrial adhesin F4ab / Escherichia coli, fimbrial adhesin F4ac / Escherichia coli, fimbrial adhesin F5 / Escherichia coli, fimbrial adhesin F6, Pigs
Date of authorisation: 09/12/2020, Revision: 1, Authorised, Last updated: 24/09/2021inactivated) / Clostridium perfringens vaccine (inactivated … inactivated) and Clostridium perfringens (inactivated) vaccine) An … E. coli) and Clostridium perfringens (C perfringens) types A and C. It contains … -
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Herbal medicinal product: Balsamum peruvianum
Myroxylon balsamum (L.) Harms var. perierae (Royle) Harms, Peru balsam, F: Assessment finalised, Last updated: 27/06/2016Balsamum peruvianum … prepared. Key facts Balsamum peruvianumPeru balsamMyroxylon balsamum … balsamum (L.) Harms var. perierae (Royle) Harms F: Assessment … -
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Human medicine European public assessment report (EPAR): Provenge
autologous peripheral-blood mononuclear cells including a minimum of 50 million autologous CD54+ cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor, Prostatic Neoplasms
Date of authorisation: 06/09/2013,, Revision: 1, Withdrawn, Last updated: 19/05/2015
Withdrawn autologous peripheral-blood mononuclear cells activated … gt;ProvengeEMEA/H/C/002513autologous peripheral-blood mononuclear cells including … colony-stimulating factorautologous peripheral-blood mononuclear cells activated … -
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Opinion/decision on a Paediatric investigation plan (PIP): Diphtheria toxoid, tetanus toxoid, pertussis toxoid, pertussis filamentous haemagglutinin, pertactin
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Infectious diseases
PIP number: EMEA-002343-PIP01-18, Route(s) of administration: Intramuscular use,
Decision date: 16/07/2019, Last updated: 13/11/2019, Compliance check: XDiphtheria toxoid tetanus toxoid pertussis toxoid pertussis filamentous haemagglutinin pertactin Infectious diseasesP/0231/2019EMEA-002343-PIP01-18 … eria toxoid tetanus toxoid pertussis toxoid pertussis filamentous haemagglutinin pertactin … -
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Press release: Review of the manufacture of Baxter's peritoneal dialysis solutions initiated over potential presence of endotoxins in some batches
CHMP, Last updated: 21/01/2011Review of the manufacture of Baxter's peritoneal dialysis solutions initiated … Review of the manufacture of Baxter's peritoneal dialysis solutions initiated … Art 31 peritoneal solutions Press release … -
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Press release: European Medicines Agency recommends action plan to deal with possible presence of endotoxins in Baxter peritoneal dialysis solutions
CHMP, Last updated: 17/12/2010presence of endotoxins in Baxter peritoneal dialysis solutions … Agency has been informed by Baxter of the potential presence … presence of endotoxins in their peritoneal dialysis solutions Dianeal … -
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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: 20/02/2023horised diphtheria, tetanus, pertussis (acellular, component), hepatitis … from diphtheria, tetanus, pertussis and Haemophilus influenzae … by infection of a wound); pertussis (whooping cough); hepatitis … -
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Human medicine European public assessment report (EPAR): Infanrix Hexa
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: 44, Authorised, Last updated: 11/05/2022diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa … INN-diphtheria (D), tetanus (T), pertussis (acellular, component) (PA … diphtheria (D), tetanus (T), pertussis (acellular, component) (PA … -
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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: 23/08/2013diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa … toxoidtetanus toxoidBordetella pertussis antigens pertussis toxoid, filamentous haemagglutinin … filamentous haemagglutinin, pertactin)poliovirus (inactivated) (type 1 (Mahoney … -
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Opinion/decision on a Paediatric investigation plan (PIP): Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigen: Pertussis toxoid, Bordetella pertussis antigen: Filamentous Haemagglutinin, Bordetella pertussis antigen: Pertactin, Inactivated poliovirus: type 1 (Mahoney strain), Inactivated poliovirus: type 2 (MEF-1 strain), Inactivated poliovirus: type 3 (Saukett strain)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000500-PIP01-08-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection, Suspension for injection in pre-filled syringe
Decision date: 07/03/2015, Last updated: 25/03/2015, Compliance check: V, 27/05/2016tetanus toxoid Bordetella pertussis antigen Pertussis toxoid Bordetella pertussis antigen: Filamentous Haemagglutinin … Tetanus toxoid / Bordetella pertussis antigen Pertussis toxoid / Bordetella pertussis antigen: Filamentous Haemagglutinin …