11784 results
-
List item
Human medicine European public assessment report (EPAR): Perjeta
pertuzumab, Breast Neoplasms
Date of authorisation: 04/03/2013, Revision: 19, Authorised, Last updated: 29/07/2020Perjeta Breast Neoplasms … Perjeta … Perjeta, INN pertuzumab 30 Churchill Place … -
List item
Referral: Basiron AC and associated names
benzoyl peroxide, Article 13 referrals
Status: European Commission final decision, opinion/position date: 28/03/2019, EC decision date: 04/07/2019, Last updated: 19/07/2019authorisation for Basiron AC (benzoyl peroxide 5% and 10% gel) in the EU … benzoyl peroxide benzoyl peroxide … -
List item
Veterinary medicine European public assessment report (EPAR): Vectra 3D
dinotefuran, pyriproxyfen, permethrin, Dogs
Date of authorisation: 04/12/2013, Revision: 5, Authorised, Last updated: 17/11/2020dinotefuran, permethrin, and pyriproxyfen … Dinotefuran / pyriproxyfen / permethrin Assessment report as … substances (dinotefuran, permethrin and pyriproxyfen) which … -
List item
Human medicine European public assessment report (EPAR): Fycompa
perampanel, Epilepsies, Partial
Date of authorisation: 23/07/2012, Revision: 19, Authorised, Last updated: 13/01/2021Authorised 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 … -
List item
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, Revision: 2, Withdrawn, Last updated: 09/12/2020
Withdrawn peramivir Overview The The approval … authorisation for Alpivab (peramivir) in the European Union (EU … Commission of its decision to permanently discontinue the marketing … -
List item
Human medicine European public assessment report (EPAR): Luminity
perflutren, Echocardiography
Date of authorisation: 20/09/2006, Revision: 14, Authorised, Last updated: 22/10/2020perflutren … Luminity perflutren perflutren … -
List item
Human medicine European public assessment report (EPAR): Optison
perflutren, Echocardiography
Date of authorisation: 17/05/1998, Revision: 18, Authorised, Last updated: 25/07/2019perflutren … CHMP) assessed the studies performed, to reach their recommendations … human albumin containing perflutren gas as the active substance … -
List item
Human medicine European public assessment report (EPAR): Phesgo
pertuzumab, trastuzumab, Breast Neoplasms
Date of authorisation: 21/12/2020,, Authorised, Last updated: 13/01/2021
pertuzumab / trastuzumab … EMEA/H/C/005386 Phesgo (pertuzumab / trastuzumab) An overview … contains the active substances pertuzumab and trastuzumab. For more … -
List item
Veterinary medicine European public assessment report (EPAR): Activyl Tick Plus
indoxacarb, permethrin, Dogs
Date of authorisation: 09/01/2012, Revision: 8, Authorised, Last updated: 19/11/2020indoxacarb / permethrin … Activyl Tick Plus (indoxacarb / permethrin) An overview of Activyl Tick … against sand flies (Phlebotomus perniciosus) that is active for up to … -
List item
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 … -
List item
Referral: Ergot-derived dopamine agonists
bromocriptine, cabergoline, dihydroergocryptine, lisuride and pergolide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/06/2008, Last updated: 26/06/2008these medicines for long periods, particularly cardiac fibrosis … dihydroergocryptine, lisuride and pergolide. They have been available … medicines are used for long periods. However, two studies published … -
List item
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-M13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Oral suspension
Decision date: 18/03/2020, Last updated: 31/07/2020, Compliance check: XFycompa Active substance perampanel Therapeutic area Neurology … Fycompa Fycompa perampanel perampanel perampanel … -
List item
Human medicine European public assessment report (EPAR): Triacelluvax
Diphtheria toxoid, haemagglutinin filamentous, adsorbed, pertactin, pertussis toxin, tetanus toxoid, Immunization, Tetanus, Whooping Cough, Diphtheria
Date of authorisation: 11/01/1999, Withdrawn, Last updated: 03/07/2002diphtheria, tetanus and acellular pertussis vaccine … diptheria, tetanus and acellular pertussis vaccine) WITHDRAWAL OF … diptheria, tetanus and acellular pertussis vaccine), indicated for active … -
List item
Herbal medicinal product: Balsamum peruvianum
Myroxylon balsamum (L.) Harms var. perierae (Royle) Harms, Peru balsam, F: Assessment finalised, Last updated: 27/06/2016Balsamum peruvianum … Balsamum peruvianum … balsamum (L.) Harms var. pereirae (Royle) Harms, balsamum … -
List item
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
autologous peripheral-blood mononuclear cells activated … for Provenge (autologous peripheral blood mononuclear cells activated … Commission of its decision to permanently discontinue the marketing … -
List item
Referral: Coversyl
Perindopril, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 27/07/2005, EC decision date: 07/11/2005, Last updated: 23/12/2005associated names contain perindopril, a well-known, potent angiotensin … The questions identified pertained to the inclusion of a specific … the beneficial effect of perindopril beyond a mere reduction of … -
List item
Referral: Coversyl
Perindopril, Article 30 referrals
Status: European Commission final decision, opinion/position date: 24/07/2003, EC decision date: 04/12/2003, Last updated: 23/12/2003Perindopril is a specific, competitive … renin-angiotensin-aldosteron system. Perindopril was initially approved in … the benefit/risk ratio of perindopril is considered favourable … -
List item
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, Pharmaceutical form(s): Solution for injection
Decision date: 16/07/2019, Last updated: 13/11/2019, Compliance check: XDiphtheria toxoid tetanus toxoid pertussis toxoid pertussis filamentous haemagglutinin pertactin Therapeutic area Infectious … eria toxoid tetanus toxoid pertussis toxoid pertussis filamentous haemagglutinin pertactin … -
List item
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: 42, Authorised, Last updated: 15/10/2020diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa … INN-diphtheria (D), tetanus (T), pertussis (acellular, component) (PA … diphtheria (D), tetanus (T), pertussis (acellular, component) (PA … -
List item
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: 8, Authorised, Last updated: 01/10/2020diphtheria, tetanus, pertussis (acellular, component), hepatitis … name: diphtheria, tetanus, pertussis (acellular, component), hepatitis … Vaxelis Diphtheria, tetanus, pertussis (acellular, component), hepatitis … -
List item
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 … -
List item
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 … -
List item
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 … Netvax, Clostridium perfringens M ed ici na l p ro du ct … the bacterium Clostridium perfringens (C perfringens) type A. The vaccine is an … -
List item
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 … -
List item
Veterinary medicine European public assessment report (EPAR): Arti-Cell Forte
chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells, Horses
Date of authorisation: 29/03/2019, Revision: 3, Authorised, Last updated: 27/10/2020induced equine allogeneic peripheral blood-derived mesenchymal … induced equine allogeneic peripheral blood-derived mesenchymal … induced equine allogeneic peripheral blood-derived mesenchymal …