13846 results
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Human medicine European public assessment report (EPAR): Perjeta (updated)
pertuzumab, Breast Neoplasms
Date of authorisation: 04/03/2013, Revision: 22, Authorised, Last updated: 29/08/2023Perjeta Skin and Connective Tissue … Authorised pertuzumab Overview Perjeta is a cancer medicine for … found on the cancer cells). Perjeta is used in the following … -
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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Date of authorisation: 11/01/1999, Withdrawn, Last updated: 03/07/2002diphtheria, tetanus and pertussis (acellular, component) vaccine … diptheria, tetanus and acellular pertussis vaccine) WITHDRAWAL OF … diptheria, tetanus and acellular pertussis vaccine), indicated for active … -
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Human medicine European public assessment report (EPAR): Luminity
perflutren, Echocardiography
Date of authorisation: 20/09/2006, Revision: 17, Authorised, Last updated: 28/06/2023Authorised 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): Fycompa
perampanel, Epilepsies, Partial
Date of authorisation: 23/07/2012, Revision: 32, Authorised, Last updated: 10/05/2023Authorised 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): 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): 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): Phesgo
pertuzumab, trastuzumab, Breast Neoplasms
Date of authorisation: 21/12/2020,, Revision: 3, Authorised, Last updated: 02/03/2022
Authorised pertuzumabtrastuzumab Overview Phesgo is a cancer … medicine. active substances pertuzumab and trastuzumab. For more … as an injection containing pertuzumab 1200 mg and trastuzumab 600 … -
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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: 04/08/2005phtheria, tetanus, acellular pertussis and hepatitis B recombinant … tetanus toxoid, acellular pertussis components pertussis toxoid, filamentous haemagglutinin … filamentous haemagglutinin and pertactin), recombinant hepatitis B surface … -
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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
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: XFycompa Active substance perampanel Therapeutic area Neurology … 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
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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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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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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Referral: Veterinary medicinal products containing N-methyl pyrrolidone as an excipient
associated names: Vectra 3D, Melovem, Article 82
Status: European Commission final decision, opinion/position date: 08/12/2022, EC decision date: 28/03/2023, Last updated: 14/04/2023medicines. This includes wearing personal protective equipment such … exposure. This includes wearing personal protective equipment such … medicines. This includes wearing personal protective equipment such … -
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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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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: 47, Authorised, Last updated: 21/09/2023diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa … against diphtheria, tetanus, pertussis (whooping cough), hepatitis … tetanus; parts of Bordetella pertussis ( B … -
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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: 20/02/2023diphtheria, tetanus, pertussis (acellular, component), hepatitis … name: diphtheria, tetanus, pertussis (acellular, component), hepatitis … Vaxelis Diphtheria, tetanus, pertussis (acellular, component), hepatitis … -
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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 … Penta (diphtheria, tetanus, pertussis (acellular, component), hepatitis … Penta (diphtheria, tetanus, pertussis (acellular, component … -
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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 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bordetella pertussis antigen: Filamentous Haemagglutinin, Bordetella pertussis antigen: Pertactin, Bordetella pertussis antigen: Pertussis toxoid, Inactivated poliovirus: type 1 (Mahoney strain), Inactivated poliovirus: type 2 (MEF-1 strain), Inactivated poliovirus: type 3 (Saukett strain), tetanus toxoid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases; Vaccines
PIP number: EMEA-003066-PIP01-21, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection in pre-filled syringe
Decision date: 03/12/2021, Last updated: 13/03/2023, Compliance check: XKey facts Bordetella pertussis antigen: Filamentous Haemagglutinin … Haemagglutinin Bordetella pertussis antigen Pertactin Bordetella pertussis antigen … tetanus toxoid, bordetella pertussis antigen pertussis toxoid, bordetella pertussis antigen: filamentous haemagglutinin … -
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Veterinary medicine European public assessment report (EPAR): Netvax
Clostridium-perfringens-type-A alpha toxoid, Chicken
Date of authorisation: 16/04/2009, Revision: 2, Withdrawn, Last updated: 11/06/2014chickens due to Clostridium perfringens Overview The marketing authorisation … chickens due to Clostridium perfringensChickenQI01AB08 Publication details >Intervet … progeny, during the laying period. To reduce mortality and the … -
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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: 16/08/2012phtheria, tetanus, acellular pertussis, inactivated poliomyelitis … diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis … diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis …