134 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
Epoetin Alfa Hexal Anemia Kidney … Authorised epoetin alfa Overview Epoetin Alfa Hexal is a medicine … blood cells is defective). Epoetin Alfa Hexal is used when patients … -
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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: 29, Authorised, Last updated: 21/12/2020epoetin beta … the public NeoRecormon epoetin beta This is a summary … contains the active substance epoetin beta. What is NeoRecormon … -
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Human medicine European public assessment report (EPAR): Retacrit
epoetin zeta, Anemia, Blood Transfusion, Autologous, Kidney Failure, Chronic, Cancer
Date of authorisation: 18/12/2007,, Revision: 27, Authorised, Last updated: 26/11/2020
Authorised epoetin zeta Overview This is a summary … of the active substance, epoetin zeta. Retacrit is a ‘biosimilar’ … Eprex / Erypo, which contains epoetin alfa. What is Retacrit used … -
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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: 17, Authorised, Last updated: 25/11/2020
Authorised epoetin zeta Overview Silapo is a … contains the active substance epoetin zeta and is a ‘biosimilar’ … Eprex/Erypo, which contains epoetin alfa. How is Silapo used? Silapo … -
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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
Authorised epoetin alfa Overview Binocrit is … contains the active substance epoetin alfa and is a ‘biosimilar … active substance in Binocrit, epoetin alfa, is a copy of a hormone … -
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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
Authorised epoetin alfa Overview Abseamed is … contains the active substance epoetin alfa and is a ‘biosimilar … active substance in Abseamed, epoetin alfa, is a copy of a hormone … -
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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: 13/06/2018Authorised epoetin theta Overview This is a … of the active substance, epoetin theta. What is Eporatio used … active substance in Eporatio, epoetin theta, is a copy of a human … -
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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: 04/05/2018Authorised epoetin theta Overview This is a … of the active substance, epoetin theta. What is Biopoin used … active substance in Biopoin, epoetin theta, is a copy of a human … -
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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: 23/04/2009Withdrawn epoetin delta Overview The marketing … STATEMENT ON Dynepo (epoetin delta) WITHDRAWAL … medicinal product Dynepo (epoetin delta), which had been approved … -
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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 … methoxy polyethylene glycol-epoetin beta), Pegasys (peginterferon … methoxy polyethylene glycol-epoetin beta, used for the treatment … -
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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 Haematology-HemostaseologyP/0317/2017EMEA-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: XEpoetin theta Haematology-Hemostaseo … Key facts epoetin theta Haematology-HemostaseologyP/55/2008Epoetin … product specific waiver for Epoetin theta (EMEA-000217-PIP01-08 … -
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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: XEpoetin theta Haematology-Hemostaseo … Key facts epoetin theta Haematology-HemostaseologyP/57/2008Epoetin … product specific waiver for Epoetin theta (EMEA-000219-PIP01-08 … -
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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: XEpoetin theta Haematology-Hemostaseo … Key facts epoetin theta Haematology-HemostaseologyP/56/2008Epoetin … product specific waiver for Epoetin theta (EMEA-000218-PIP01-08 … -
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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 patie … the product information for epoetin-containing medicines with a new warning … patients suffering cancer. Epoetin-containing medicines are indicated in … -
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News: Public Statement: Epoetins and the risk of tumour growth progression and thromboembolic events in cancer patients and cardiovascular risks in patients with chronic kidney disease
CHMP, Last updated: 23/10/2007Public Statement: Epoetins and the risk of tumour growth … recently reviewed the safety of epoetins. These medicines are used … who have been treated with epoetins. In addition, the results … -
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Similar biological medicinal products containing recombinant erythropoietins
Last updated: 23/07/2018recombinant human erythropoietin (epoetin)-containing medicinal products claiming … Keywords Erythropoietin, Epoetin, recombinant biological medicinal … recombinant human erythropoietin (epoetin)-containing medicinal products claiming …
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018
CHMP, Last updated: 27/07/2018Epoetin alfa Hexal, Kalydeco, Mekinist … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,23-26 June 2008
CHMP, Last updated: 26/06/2008recommended a new warning for epoetin-containing medicines. These medicines … QUESTIONS AND ANSWERS ON EPOETINS AND THE RISK OF TUMOUR … has reviewed the safety of epoetins used in cancer patients … -
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Human medicine European public assessment report (EPAR): Aranesp (updated)
darbepoetin alfa, Anemia, Cancer, Kidney Failure, Chronic
Date of authorisation: 08/06/2001, Revision: 43, Authorised, Last updated: 24/03/2021patients who were administered epoetin alfa (Leyland-Jones B, 2003 … Leyland-Jones B, 2003) or epoetin beta (Henke M et al, 2003 … with cancer treated with epoetins. Further to the recommendations … -
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Human medicines highlights: Issue 27 - April 2011
Last updated: 06/05/2011Epostim ( epoetin alfa ) Intended for the treatment …
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Human medicine European public assessment report (EPAR): Alli (previously Orlistat GSK) (updated)
orlistat, Obesity
Date of authorisation: 22/07/2007, Revision: 17, Authorised, Last updated: 31/03/2021methoxy polyethylene glycol-epoetin beta), Pegasys (peginterferon … methoxy polyethylene glycol-epoetin beta, used for the treatment … -
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Human medicine European public assessment report (EPAR): Xeloda (updated)
capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Date of authorisation: 02/02/2001,
, Revision: 26, Authorised, Last updated: 26/03/2021
methoxy polyethylene glycol-epoetin beta), Pegasys (peginterferon … methoxy polyethylene glycol-epoetin beta, used for the treatment …