458 results
Keyword epoetin Remove keyword
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Human medicine European public assessment report (EPAR): Epoetin Alfa Hexal
epoetin alfa, Anemia, Kidney Failure, Chronic, Cancer
Date of authorisation: 27/08/2007,
, Revision: 22, Authorised, Last updated: 09/10/2019
ASSESSMENT REPORT FOR EPOETIN ALFA HEXAL International … non-proprietary name/Common name: epoetin alfa Procedure No. EMEA/H/C/725/II/0006 … as expression system. Epoetin alfa Hexal (HX575) has been … -
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Human medicine European public assessment report (EPAR): Retacrit (updated)
epoetin zeta, Anemia, Blood Transfusion, Autologous, Kidney Failure, Chronic, Cancer
Date of authorisation: 18/12/2007,, Revision: 26, Authorised, Last updated: 04/05/2020
Retacrit, INN-Epoetin zeta 7 Westferry … for the public Retacrit epoetin zeta This document is a … of the active substance, epoetin zeta. Retacrit is a ‘biosimilar’ … -
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Human medicine European public assessment report (EPAR): Silapo
epoetin zeta, Anemia, Blood Transfusion, Autologous, Cancer, Kidney Failure, Chronic
Date of authorisation: 18/12/2007,, Revision: 16, Authorised, Last updated: 07/04/2020
progenitors in the bone marrow. Epoetin-containing medicinal products are currently … biosimilar product referring to epoetin alfa, authorised in the EU … that efficacy and safety of Epoetin zeta have not been demonstrated … -
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Human medicine European public assessment report (EPAR): Binocrit
epoetin alfa, Anemia, Kidney Failure, Chronic
Date of authorisation: 28/08/2007,, Revision: 20, Authorised, Last updated: 31/10/2019
Binocrit, INN-epoetin alfa European Medicines … non-proprietary name/Common name: epoetin alfa Procedure No. EMEA/H/C/725/II/0006 … reference product Eprex/Erypo (epoetin alfa, Janssen-Cilag GmbH … -
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Human medicine European public assessment report (EPAR): Abseamed
epoetin alfa, Anemia, Kidney Failure, Chronic, Cancer
Date of authorisation: 27/08/2007,
Date of refusal: 18/06/2009,, Revision: 22, Authorised, Last updated: 08/10/2019
Abseamed, INN-epoetin alfa 1/26 ©EMEA 2007 SCIENTIFIC … as expression system. All epoetins in clinical use have a similar … particularly immunogenicity. Epoetin-containing medicinal products are currently … -
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Human medicine European public assessment report (EPAR): NeoRecormon
epoetin beta, Kidney Failure, Chronic, Anemia, Cancer, Blood Transfusion, Autologous
Date of authorisation: 16/07/1997, Revision: 28, Authorised, Last updated: 22/08/2019the public NeoRecormon epoetin beta This is a summary … contains the active substance epoetin beta. What is NeoRecormon … substance in NeoRecormon, epoetin beta, is a copy of a human … -
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Human medicine European public assessment report (EPAR): Eporatio
epoetin theta, Kidney Failure, Chronic, Anemia, Cancer
Date of authorisation: 29/10/2009, Revision: 11, Authorised, Last updated: 13/06/2018Eporatio, INN - epoetin theta European Medicines … EMEA/H/C/1033 Eporatio epoetin theta EPAR summary for … of the active substance, epoetin theta. What is Eporatio … -
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Human medicine European public assessment report (EPAR): Biopoin
epoetin theta, Kidney Failure, Chronic, Anemia, Cancer
Date of authorisation: 23/10/2009, Revision: 13, Authorised, Last updated: 04/05/2018Biopoin, INN - epoetin theta European Medicines … EMEA/H/C/1036 Biopoin epoetin theta EPAR summary for … of the active substance, epoetin theta. What is Biopoin … -
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Human medicine European public assessment report (EPAR): Dynepo
epoetin delta, Kidney Failure, Chronic, Anemia
Date of authorisation: 18/03/2002,
Date of refusal: 12/03/2008, Revision: 9, Withdrawn, Last updated: 23/04/2009STATEMENT ON Dynepo (epoetin delta) WITHDRAWAL … medicinal product Dynepo (epoetin delta), which had been approved … Dynepo, INN-Epoetin delta Me dic ina l p rod uc t … -
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Withdrawn application: Epostim
epoetin alfa, date of withdrawal: 15/03/2011, Initial authorisation, Last updated: 19/04/2011application for Epostim (epoetin alfa) 7 Westferry … application for Epostim (epoetin alfa) On 15 March 2011 … contains the active substance epoetin alfa. Epostim was developed … -
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Withdrawn application: Ratioepo
epoetin theta, date of withdrawal: 25/02/2010, Initial authorisation, Last updated: 22/03/2010Nonproprietary Name (INN): epoetin theta On 23 July 2009 the … substance of Ratioepo is epoetin theta, a recombinant human … application for Ratioepo1 (epoetin theta) On 25 February … -
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Human medicine European public assessment report (EPAR): Mircera
Methoxy polyethylene glycol-epoetin beta, Anemia, Kidney Failure, Chronic
Date of authorisation: 20/07/2007, Revision: 25, Authorised, Last updated: 20/12/2019methoxy polyethylene glycol-epoetin beta), Pegasys (peginterferon … methoxy polyethylene glycol-epoetin beta, used for the treatment … methoxy polyethylene glycol-epoetin beta This document is a … -
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Opinion/decision on a Paediatric investigation plan (PIP): Mircera, Methoxy polyethylene glycol-epoetin beta
Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000172-PIP01-07-M03, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 31/10/2017, Last updated: 13/02/2018, Compliance check: Xmethoxy polyethylene glycol - epoetin beta (Mircera), (EMEA-000172-PIP01-07-M03 … methoxy polyethylene glycol - epoetin beta (Mircera), (EMEA-000172-PIP01-07-M03 … methoxy polyethylene glycol - epoetin beta (Mircera), (EMEA-000172-PIP01-07-M03 … -
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Opinion/decision on a Paediatric investigation plan (PIP): epoetin theta
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: Epoetin theta, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 20/07/2008, Last updated: 08/09/2008, Compliance check: Xproduct specific waiver for Epoetin theta (EMEA-000217-PIP01-08 … product specific waiver for Epoetin theta (EMEA-000217-PIP01-08 … Article 1 A waiver for Epoetin theta, Solution for injection … -
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Opinion/decision on a Paediatric investigation plan (PIP): epoetin theta
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: Epoetin theta, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 20/07/2008, Last updated: 08/09/2008, Compliance check: Xproduct specific waiver for Epoetin theta (EMEA-000218-PIP01-08 … product specific waiver for Epoetin theta (EMEA-000218-PIP01-08 … Article 1 A waiver for Epoetin theta, Solution for injection … -
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Opinion/decision on a Paediatric investigation plan (PIP): epoetin theta
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Haematology-Hemostaseology
PIP number: Epoetin theta, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 20/07/2008, Last updated: 08/09/2008, Compliance check: Xproduct specific waiver for Epoetin theta (EMEA-000219-PIP01-08 … product specific waiver for Epoetin theta (EMEA-000219-PIP01-08 … Article 1 A waiver for Epoetin theta, Solution for injection … -
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Press release: EMEA recommends a new warning for epoetins for their use in cancer patients
CHMP, Last updated: 26/06/2008recommends a new warning for epoetins for their use in cancer patients … product information for epoetin-containing medicines with a new warning … patients suffering cancer. Epoetin-containing medicines are indicated in …