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Orphan designation: 5(S)-(2'-hydroxy ethoxy)-20(S)-Camptothecin for: Treatment of osteosarcoma
Date of designation: 08/06/2007, Withdrawn, Last updated: 14/08/20175(S)-(2'-hydroxy ethoxy)-20(S)-Camptothecin Overview … Medicinal Products in July 2017 on request of the sponsor … of the sponsor. On 8 June 2007, orphan designation (EU/3/07/450 … -
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Orphan designation: Recombinant chimeric monoclonal antibody against CD20 (ublituximab) for: Treatment of chronic lymphocytic leukaemia
Date of designation: 26/11/2009, Positive, Last updated: 22/11/2022monoclonal antibody against CD20 (ublituximab) Overview On … ublituximab) Overview On 26 November 2009, A status assigned to a medicine … monoclonal antibody against CD20 for the treatment of chronic … -
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Orphan designation: Pegylated recombinant human hyaluronidase PH20(pegvorhyaluronidase alfa) for: Treatment of pancreatic cancer
Date of designation: 16/12/2014, Positive, Last updated: 22/02/2019recombinant human hyaluronidase PH20(pegvorhyaluronidase alfa … alfa) Overview On 16 December 2014, orphan designation (EU/3/14/1394 … recombinant human hyaluronidase PH20 for the treatment of pancreatic … -
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Orphan designation: Genetically modified human adenovirus encoding human PH20 hyaluronidase for: Treatment of pancreatic cancer
Date of designation: 21/06/2011, Positive, Last updated: 31/07/2013adenovirus encoding human PH20 hyaluronidase Overview On … hyaluronidase Overview On On 21 June 2011, orphan designation (EU/3/11/880 … adenovirus encoding human PH20 hyaluronidase for the treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): Humenza, Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000669-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for injection
Decision date: 04/01/2019, Last updated: 21/09/2021, Compliance check: V, 26/04/2019equivalent to A/California/7/2009 (H1N1)-like strain (A/Califor … H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted … adjuvanted VaccinesP/0022/2019EMEA-000669-PIP01-09-M02 Suspension … -
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Opinion/decision on a Paediatric investigation plan (PIP): Prepandrix, Purified antigen fractions of inactivated split virion Influenza A/Vietnam/1194/2004 (H5N1) like strain used (NIBRG-14), Purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000160-PIP01-07-M05, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Emulsion and suspension for emulsion for injection
Decision date: 14/08/2019, Last updated: 21/09/2021, Compliance check: V, 31/01/2020Influenza A/Vietnam/1194/2004 (H5N1) like strain used (NIBRG-14 … Influenza A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2 … PR8-IBCDC-RG2) VaccinesP/0299/2019EMEA-000160-PIP01-07-M05 Emulsion … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fluenz, Influenza Virus Type A, H3N2Influenza Virus Type A, H1N1Influenza Virus Type B
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-000249-PIP01-10, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray suspension
Decision date: 03/01/2011, Last updated: 07/02/2011, Compliance check: XVirus Type B VaccinesP/14/2011EMEA-000249-PIP01-10 Nasal … deferral(s) Decision P/14/2011: EMA decision of 3 January 2011 on the review of a granted … WC500101887_en.pdf Adopted 07/02/2011 07/02 … -
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Opinion/decision on a Paediatric investigation plan (PIP): A/California/7/2009 influenza-like virus strain
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000663-PIP01-09-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 30/07/2010, Last updated: 26/08/2010, Compliance check: XKey facts A/California/7/2009 influenza-like virus strain … virus strain VaccinesP/146/2010EMEA-000663-PIP01-09-M03 Suspension … agreed PIP Decision P/146/2010: European Medicines Agency … -
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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
strain called A/Vietnam/1194/2004 (H5N1). How is Foclivia used … throughout the EU on 19 October 2009. The authorisation was based … authorisation granted to Focetria in 2007 (‘informed consent’ … -
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Veterinary medicine European public assessment report (EPAR): Respiporc FLUpan H1N1
Influenza A virus/human strain: A/Jena/VI5258/2009 (H1N1)pdm09, inactivated, Pigs
Date of authorisation: 17/05/2017, Revision: 6, Authorised, Last updated: 21/03/2022throughout the EU on 17 May 2017. Summary documents Respiporc … European Medicines Agency, 2022. Reproduction is authorised … acknowledged. EMA/188700/2017 EMEA/V/C/003993 Respiporc … -
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Human medicine European public assessment report (EPAR): Prepandrix
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 14/05/2008,
, Revision: 13, Withdrawn, Last updated: 23/02/2021
European Medicines Agency, 2020. Reproduction is authorised … acknowledged. 23 December 2020 EMEA/H/C/000822 Public … European Union On 17 December 2020, the European Commission withdrew … -
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Veterinary medicine European public assessment report (EPAR): Proteq West Nile
West Nile recombinant canarypox virus (vCP2017 virus), Horses
Date of authorisation: 05/08/2011, Revision: 15, Authorised, Last updated: 15/02/2021recombinant canarypox virus (vCP2017). It is available as a suspension … disease. The vaccine strain vCP2017 in Proteq West Nile is a … throughout the EU on 5 August 2011. List item … -
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Veterinary medicine European public assessment report (EPAR): Horse Allo 20
allogeneic equine adipose-derived mesenchymal stem cells, Horses
Date of refusal: 13/05/2019, Refused, Last updated: 12/09/2019Horse Allo 20 … cells Overview On 21 June 2018, the Committee for Medicinal … medicinal product Horse Allo 20, intended for the treatment … -
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Orphan designation: 17α,21-Dihydroxy-16α-methyl-pregna-1,4,9(11)-triene-3,20-dione (vamorolone) for: Treatment of Duchenne muscular dystrophy
Date of designation: 22/08/2014, Positive, Last updated: 14/09/2022vamorolone) Overview On 22 August 2014, A status assigned to a medicine … of 512,900,000 (Eurostat 2014). What treatments are available … with Regulation (EC) No 141/2000 of 16 December 1999, the … -
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Orphan designation: copper meso-5,15-bis[3-[(1,2-dicarba-closo-dodecaboranyl)methoxy]phenyl]-meso-10,20-dinitroporphyrin for: Treatment of squamous-cell carcinoma of the head and neck in patients undergoing radiotherapy
Date of designation: 27/06/2013, Withdrawn, Last updated: 10/12/2020Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0 20 3660 5555 Send a question … European Medicines Agency, 2020. Reproduction is authorised … acknowledged. 6 March 2015 EMA/COMP/309838 … -
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Orphan designation: [5,10,15,20-tetrakis(4-carboxyphenyl)-21H,23H-porphine]manganese(III) chloride for: Treatment of Cockayne syndrome
Date of designation: 12/01/2017, Positive, Last updated: 13/07/20175,10,15,20-tetrakis(4-carboxyphenyl)-21H,23H-porphine]manganese(III … chloride Overview On 12 January 2017, orphan designation (EU/3/16/1809 … Pasteur, France, for [5,10,15,20-tetrakis(4-carboxyphenyl)-21H,23H-porphine]manganese(III … -
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Orphan designation: 5,10,15,20-tetrakis(2,6-difluoro-3-N-methylsulfamoylphenyl)bacteriochlorin (redaporfin) for: Treatment of biliary tract cancer
Date of designation: 19/03/2015, Positive, Last updated: 11/05/20155,10,15,20-tetrakis(2,6-difluoro-3-N-methylsulfamoylphenyl)bacteriochlorin … as redaporfin. On 19 March 2015, orphan designation (EU/3/15/1470 … S.A., Portugal, for 5,10,15,20-tetrakis(2,6-difluoro-3-N-methylsulfamoylphenyl … -
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Opinion/decision on a Paediatric investigation plan (PIP): Antigen of pre-pandemic strain A/Vietnam/1203/2004 propagated in Vero cells
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000156-PIP01-07-M02, Route(s) of administration: Intramuscular injection, Pharmaceutical form(s): Suspension for injection
Decision date: 11/03/2011, Last updated: 08/04/2011, Compliance check: V, 17/01/2013pre-pandemic strain A/Vietnam/1203/2004 propagated in Vero cells … in Vero cells VaccinesP/67/2011EMEA-000156-PIP01-07-M02 Suspension … EMEA-C-000156-PIP01-07-M02 17/01/2013 positive Decision P/67 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense, Secale cereale (20% each)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000864-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oralmucosal drops
Decision date: 22/12/2010, Last updated: 24/01/2011, Compliance check: Xpratense, Secale cereale (20% each) Pneumology-allergologyP/302/2010EMEA-000864-PIP01-10 … deferral(s) Decision P/302/2010: EMA decision of 22 December 2010 on the agreement of a paediatric … pratense, Secale cereale (20% each) To: Head of Paediatric … -
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomarata, Lolium perenne, Phleum pratense, Poa pratensis and Anthoxhantum odoratum (20% each)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000856-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oralmucosal drops
Decision date: 22/12/2010, Last updated: 24/01/2011, Compliance check: Xand Anthoxhantum odoratum (20% each) Pneumology-allergologyP/299/2010EMEA-000856-PIP01-10 … deferral(s) Decision P/299/2010: EMA decision of 22 December 2010 on the agreement of a paediatric … and Anthoxhantum odoratum (20% each) To: Head of Paediatric … -
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva
SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022,
, Revision: 5, Authorised, Last updated: 17/02/2023
against coronavirus disease 2019 (COVID-19). It is used for … European Medicines Agency, 2022. Reproduction is authorised … acknowledged. 23 June 2022 EMEA/H/C/006019 COVID-19 … -
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Human medicine European public assessment report (EPAR): Vepacel
Influenza virus (whole virion, inactivated), containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 17/02/2012, Revision: 9, Withdrawn, Last updated: 28/10/2020First published: 16/03/2012 Last updated: 12/02 2014 EMA/991112 2011 Click to see translations … antigen of: A/Vietnam/1203/2004 (H5N1 … -
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Human medicine European public assessment report (EPAR): Celvapan
Whole virion influenza vaccine, inactivated containing antigen of strain A/California/07/2009 (H1N1)v, Disease Outbreaks; Influenza, Human; Immunization
Date of authorisation: 04/03/2009, Revision: 11, Withdrawn, Last updated: 21/12/2016WC500022671_sv.pdf 08/10/2009 21/12 2016 Generic More detail is available … was last updated on 21/12/2016 Authorisation details Product … of strain A/California/07/2009 (H1N1)vinfluenza vaccine … -
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Human medicine European public assessment report (EPAR): Pandemrix
split influenza virus inactivated, containing antigen equivalent to A/California/07/2009 (H1N1)-derived strain used NYMC X-179A, Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 20/05/2008, Revision: 23, Withdrawn, Last updated: 10/06/2016First published: 22/12/2009 Last updated: 10/06 2016 EMA/684025 2012 Click to see translations … Public Statement 19 October 2015 30 Churchill Place … Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0 20 3660 5555 Send a question … -
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Human medicine European public assessment report (EPAR): Focetria
Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/California/7/2009 (H1N1)-derived strain used NYMC X-181, Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 02/05/2007,
Date of refusal: 07/05/2007, Revision: 9, Withdrawn, Last updated: 11/02/2016WC500023756_sv.pdf 04/12/2009 05/10 2010 Generic More detail is available … was last updated on 11/02/2016 Authorisation details Product … of strain: A/California/7/2009 (H1N1)-derived strain used …