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Epoetin Alfa Hexal : EPAR - Product information (PDF/522.25 KB)

Document details Epoetin Alfa Hexal : EPAR - Product … Epoetin Alfa Hexal : EPAR - Product …

First published: 02/10/2018
Last updated: 09/10/2019
Bulgarian
(PDF/730.6 KB)

Croatian
(PDF/662.55 KB)

Czech
(PDF/686.84 KB)

Danish
(PDF/529.64 KB)

Dutch
(PDF/538.13 KB)

Estonian
(PDF/480.31 KB)

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(PDF/538.07 KB)

French
(PDF/541.14 KB)

German
(PDF/534.33 KB)

Greek
(PDF/795.06 KB)

Hungarian
(PDF/683.35 KB)

Icelandic
(PDF/483.49 KB)

Italian
(PDF/528.19 KB)

Latvian
(PDF/672.19 KB)

Lithuanian
(PDF/653.43 KB)

Maltese
(PDF/726.48 KB)

Norwegian
(PDF/516.2 KB)

Polish
(PDF/690.87 KB)

Portuguese
(PDF/533.88 KB)

Romanian
(PDF/695.02 KB)

Slovak
(PDF/659.59 KB)

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(PDF/608.99 KB)

Spanish
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(PDF/498.58 KB)
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Epoetin Alfa Hexal : EPAR - All Authorised presentations (PDF/64.45 KB)

Document details Epoetin Alfa Hexal : EPAR - All Authorised … Epoetin Alfa Hexal : EPAR - All Authorised …

First published: 12/10/2009
Last updated: 02/10/2018
Bulgarian
(PDF/98.61 KB)

Croatian
(PDF/60.84 KB)

Czech
(PDF/99.69 KB)

Danish
(PDF/48.22 KB)

Dutch
(PDF/60.99 KB)

Estonian
(PDF/56.98 KB)

Finnish
(PDF/48.79 KB)

French
(PDF/64.12 KB)

German
(PDF/45.9 KB)

Greek
(PDF/101.75 KB)

Hungarian
(PDF/82.52 KB)

Icelandic
(PDF/47.08 KB)

Italian
(PDF/49.82 KB)

Latvian
(PDF/98.95 KB)

Lithuanian
(PDF/71.56 KB)

Maltese
(PDF/109.62 KB)

Norwegian
(PDF/45.65 KB)

Polish
(PDF/104.92 KB)

Portuguese
(PDF/64.99 KB)

Romanian
(PDF/90.74 KB)

Slovak
(PDF/93.69 KB)

Slovenian
(PDF/80.66 KB)

Spanish
(PDF/55.92 KB)

Swedish
(PDF/49.22 KB)
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Epoetin Alfa Hexal : EPAR - Product Information

Document details Epoetin Alfa Hexal : EPAR - Product … Epoetin Alfa Hexal : EPAR - Product …

First published: 12/10/2009
Last updated: 24/10/2017
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Epoetin Alfa Hexal : EPAR - Scientific Discussion (PDF/199.06 KB)

as expression system. All epoetins in clinical use have a similar … particularly immunogenicity. Epoetin-containing medicinal products are currently … The mechanism of action of epoetin is the same in all currently …

First published: 13/09/2007
Last updated: 13/09/2007
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Epoetin Alfa Hexal : EPAR - Summary for the public (PDF/87.92 KB)

Document details Epoetin Alfa Hexal : EPAR - Summary … Epoetin Alfa Hexal : EPAR - Summary …

First published: 12/10/2009
Last updated: 02/10/2018
Bulgarian
(PDF/116.38 KB)

Croatian
(PDF/110.39 KB)

Czech
(PDF/116.75 KB)

Danish
(PDF/86 KB)

Dutch
(PDF/88.42 KB)

Estonian
(PDF/85.96 KB)

Finnish
(PDF/87.08 KB)

French
(PDF/90.05 KB)

German
(PDF/90.53 KB)

Greek
(PDF/125.48 KB)

Hungarian
(PDF/109.04 KB)

Italian
(PDF/87.26 KB)

Latvian
(PDF/117.4 KB)

Lithuanian
(PDF/114.42 KB)

Maltese
(PDF/118.1 KB)

Polish
(PDF/115.68 KB)

Portuguese
(PDF/88.62 KB)

Romanian
(PDF/119.61 KB)

Slovak
(PDF/115.39 KB)

Slovenian
(PDF/109.09 KB)

Spanish
(PDF/89.48 KB)

Swedish
(PDF/86.27 KB)
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Epoetin Alfa Hexal-H-C-726-X-10 : EPAR - Assessment Report - Variation (PDF/50.21 KB)

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 …

First published: 16/12/2008
Last updated: 16/12/2008
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Epoetin Alfa Hexal : EPAR - Procedural steps taken before authorisation (PDF/26 KB)

Document details Epoetin Alfa Hexal : EPAR - Procedural … Epoetin Alfa Hexal : EPAR - Procedural …

First published: 17/09/2007
Last updated: 17/09/2007
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Epoetin Alfa Hexal : EPAR Risk-management-plan summary (PDF/106.55 KB)

for Abseamed/ Binocrit / Epoetin alfa Hexal/ (INN epoetin alfa) This is a summary … Abseamed®/, Binocrit®/, Epoetin alfa Hexal® epoetin alfa).The RMP details important … Document details Epoetin Alfa Hexal : EPAR Risk-management-plan …

First published: 02/10/2018
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Press release: EMEA recommends a new warning for epoetins for their use in cancer patients

CHMP, Last updated: 26/06/2008

recommends 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 …
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Epoetin Alfa Hexal : EPAR - Procedural steps taken and scientific information after authorisation (PDF/255.32 KB)

Document details Epoetin Alfa Hexal : EPAR - Procedural … Epoetin Alfa Hexal : EPAR - Procedural …

First published: 12/10/2009
Last updated: 09/10/2019
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CHMP post-authorisation summary of positive opinion for Epoetin alfa Hexal (PDF/82.93 KB)

opinion1 (post authorisation) Epoetin alfa Hexal epoetin alfa On 26 July 2018 … for the medicinal product Epoetin alfa Hexal. The marketing … indication as follows: “Epoetin alfa Hexal is indicated for …

Adopted
First published: 27/07/2018
Last updated: 27/07/2018
EMA/CHMP/503858/2018
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Epoetin Alfa Hexal : EPAR - Conditions imposed on member states for safe and effective use - Annex IV (PDF/18.89 KB)

elements:  That the use of epoetin alfa products can cause immunogenicity … PRCA)  That with other epoetin products, the risk of immunogenicity … There is insufficient data on Epoetin alfa HEXAL to know the size …

First published: 13/09/2007
Last updated: 18/04/2011
Bulgarian
(PDF/86.71 KB)

Czech
(PDF/86.72 KB)

Danish
(PDF/19.05 KB)

Dutch
(PDF/19.64 KB)

Estonian
(PDF/19.76 KB)

Finnish
(PDF/19.45 KB)

French
(PDF/19.52 KB)

German
(PDF/19.71 KB)

Greek
(PDF/87.01 KB)

Hungarian
(PDF/56.88 KB)

Icelandic
(PDF/19.43 KB)

Italian
(PDF/19.43 KB)

Latvian
(PDF/87.3 KB)

Lithuanian
(PDF/89.33 KB)

Maltese
(PDF/90.47 KB)

Norwegian
(PDF/19.41 KB)

Polish
(PDF/90.25 KB)

Portuguese
(PDF/19.47 KB)

Romanian
(PDF/85.16 KB)

Slovak
(PDF/85.76 KB)

Slovenian
(PDF/83.99 KB)

Spanish
(PDF/19.5 KB)

Swedish
(PDF/19.42 KB)
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CHMP post-authorisation summary of positive opinion for Epoetin alfa Hexal on 23 October 2008 (PDF/35.21 KB)

POSITIVE OPINION* for EPOETIN ALFA HEXAL International … Nonproprietary Name (INN): epoetin alfa On 23 October 2008 … for the medicinal product Epoetin alfa Hexal. The Marketing …

Adopted
First published: 23/10/2008
Last updated: 23/10/2008
EMEA/CHMP/567074/2008
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EMEA recommends a new warning for epoetins for their use in cancer patients (PDF/34.23 KB)

recommends 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 …

First published: 26/06/2008
Last updated: 26/06/2008
EMEA/CHMP/333963/2008 –corr
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Epoetin Alfa Hexal-H-C-726-WS-1406-0069 : EPAR - Assessment report - Variation (PDF/228.18 KB)

Document details Epoetin Alfa Hexal-H-C-726-WS-1406-0069 … Epoetin Alfa Hexal-H-C-726-WS-1406-0069 …

Adopted
First published: 02/10/2018
EMA/CHMP/549796/2018
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Questions and answers on epoetins and the risk of tumour growth and blood clots in the veins (PDF/37.79 KB)

QUESTIONS AND ANSWERS ON EPOETINS AND THE RISK OF TUMOUR … has reviewed the safety of epoetins used in cancer patients … prescribing information for all epoetin-containing medicines stating that blood …

First published: 26/06/2008
Last updated: 26/06/2008
EMEA/CHMP/333962/2008
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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: 23/10/2007

recently reviewed the safety of epoetins. These medicines are used … who have been treated with epoetins. In addition, the results … treatment of anaemia with epoetins in patients with chronic …
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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 (PDF/33.22 KB)

Epoetins Public Statement … EMEA/496188/2007 Public Statement Epoetins and the risk of tumour growth … recently reviewed the safety of epoetins. These medicines are used …

First published: 23/10/2007
Last updated: 23/10/2007
EMEA/496188/2007
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018

CHMP, Last updated: 27/07/2018

Epoetin 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: 26/06/2008

QUESTIONS AND ANSWERS ON EPOETINS AND THE RISK OF TUMOUR … has reviewed the safety of epoetins used in cancer patients … prescribing information for all epoetin-containing medicines stating that blood …
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Eporatio : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/67.81 KB)

Eporatio, INN-epoetin theta 30 Churchill … authorisation(s) Active substance(s): epoetin theta Procedure No. EMEA/H/C/PSUSA/00001240/201504 … Assessment Report on the PSUR for epoetin theta, the scientific conclusions …

First published: 30/03/2016
Last updated: 30/03/2016
EMA/26668/2016
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 July 2012

CHMP, Last updated: 20/07/2012

methoxy polyethylene glycol-epoetin beta, peginterferon alfa-2a …
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)20-23 June 2011

CHMP, Last updated: 24/06/2011

neuropathy.  Retacrit (epoetin zeta), from Hospira UK Ltd … epoetin zeta), from Hospira UK Ltd …
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Committee for Medicinal Products for Human Use (CHMP): 17-20 September 2018

European Medicines Agency, London, UK, from 17/09/2018 to 20/09/2018, Last updated: 31/10/2018
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Committee for Medicinal Products for Human Use (CHMP): 17-20 July 2017

European Medicines Agency, London, UK, from 17/07/2017 to 20/07/2017, Last updated: 06/01/2014

191 results

Epoetin Alfa Hexal : EPAR - Product information (PDF/522.25 KB)

Epoetin Alfa Hexal : EPAR - All Authorised presentations (PDF/64.45 KB)

Epoetin Alfa Hexal : EPAR - Product Information

Epoetin Alfa Hexal : EPAR - Scientific Discussion (PDF/199.06 KB)

Epoetin Alfa Hexal : EPAR - Summary for the public (PDF/87.92 KB)

Epoetin Alfa Hexal-H-C-726-X-10 : EPAR - Assessment Report - Variation (PDF/50.21 KB)

Epoetin Alfa Hexal : EPAR - Procedural steps taken before authorisation (PDF/26 KB)

Epoetin Alfa Hexal : EPAR Risk-management-plan summary (PDF/106.55 KB)

Press release: EMEA recommends a new warning for epoetins for their use in cancer patients

Epoetin Alfa Hexal : EPAR - Procedural steps taken and scientific information after authorisation (PDF/255.32 KB)

CHMP post-authorisation summary of positive opinion for Epoetin alfa Hexal (PDF/82.93 KB)

Epoetin Alfa Hexal : EPAR - Conditions imposed on member states for safe and effective use - Annex IV (PDF/18.89 KB)

CHMP post-authorisation summary of positive opinion for Epoetin alfa Hexal on 23 October 2008 (PDF/35.21 KB)

EMEA recommends a new warning for epoetins for their use in cancer patients (PDF/34.23 KB)

Epoetin Alfa Hexal-H-C-726-WS-1406-0069 : EPAR - Assessment report - Variation (PDF/228.18 KB)

Questions and answers on epoetins and the risk of tumour growth and blood clots in the veins (PDF/37.79 KB)

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

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 (PDF/33.22 KB)

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018

Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,23-26 June 2008

Eporatio : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/67.81 KB)

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 July 2012

Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)20-23 June 2011

Committee for Medicinal Products for Human Use (CHMP): 17-20 September 2018

Committee for Medicinal Products for Human Use (CHMP): 17-20 July 2017