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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)

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(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)

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(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)

Slovenian
(PDF/608.99 KB)

Spanish
(PDF/519.99 KB)

Swedish
(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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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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Questions and answers on the withdrawal of the marketing authorisation application for Epostim (epoetin alfa) (PDF/133.21 KB)

application for Epostim (epoetin alfa) 7 Westferry … application for Epostim (epoetin alfa) On 15 March 2011 … contains the active substance epoetin alfa. Epostim was developed …

First published: 19/04/2011
Last updated: 19/04/2011
EMA/287731/2011
Bulgarian
(PDF/167.99 KB)

Czech
(PDF/157.42 KB)

Danish
(PDF/72.56 KB)

Dutch
(PDF/69.46 KB)

Estonian
(PDF/67.46 KB)

Finnish
(PDF/130.09 KB)

French
(PDF/73.43 KB)

German
(PDF/73.53 KB)

Greek
(PDF/110.39 KB)

Hungarian
(PDF/93.46 KB)

Italian
(PDF/70.64 KB)

Latvian
(PDF/158.57 KB)

Lithuanian
(PDF/95.38 KB)

Maltese
(PDF/97.97 KB)

Polish
(PDF/97.08 KB)

Portuguese
(PDF/73.45 KB)

Romanian
(PDF/115.91 KB)

Slovak
(PDF/155.69 KB)

Slovenian
(PDF/152.58 KB)

Spanish
(PDF/70.67 KB)

Swedish
(PDF/128.43 KB)
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Questions and answers on the withdrawal of the marketing authorisation application for Ratioepo (epoetin theta) (PDF/65.8 KB)

application for Ratioepo1 (epoetin theta) On 25 February … of the active substance, epoetin theta. What was Ratioepo … application for RatioepoF F (epoetin theta) EMA/146533/2010 …

First published: 22/03/2010
Last updated: 22/03/2010
EMA/146533/2010
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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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Public statement: European Medicines Agency starts review of the safety of epoetins (PDF/31.65 KB)

EMEA Public statement on Epoetins 27 April 2007 FINAL corr.doc … starts review of the safety of epoetins The European Medicines … all centrally-authorised epoetins1. The safety review has been …

First published: 28/04/2007
Last updated: 28/04/2007
EMEA/188068/2007 - 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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European Medicines Agency 2011 priorities for drug safety research: Epoetins and tumour progression, shortened survival, mortality and thromboembolic events (PDF/45.49 KB)

Drug Safety Research Epoetins and tumour progression, shortened … for drug safety research: Epoetins and tumour progression, shortened … for drug safety research: Epoetins and tumour progression, shortened …

Adopted
First published: 08/07/2010
Last updated: 08/07/2010
EMA/425285/2010
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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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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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P/0317/2017: EMA decision of 31 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for methoxy polyethylene glycol - epoetin beta (Mircera) (EMEA-000172-PIP01-07-M03) (PDF/131.07 KB)

methoxy 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 …

First published: 13/02/2018
Last updated: 13/02/2018
EMA/662067/2017
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P/0049/2017: EMA decision of 6 March 2017 on the refusal of a modification of an agreed paediatric investigation plan for methoxy polyethylene glycol - epoetin beta (Mircera), (EMEA-000172-PIP01-07-M02) (PDF/103.92 KB)

methoxy polyethylene glycol - epoetin beta (Mircera), (EMEA-000172-PIP01-07-M02 … methoxy polyethylene glycol - epoetin beta (Mircera), (EMEA-000172-PIP01-07-M02 … methoxy polyethylene glycol - epoetin beta (Mircera), (EMEA-000172-PIP01-07-M02 …

Adopted
First published: 20/04/2017
Last updated: 20/04/2017
EMA/2920/2017
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P/0263/2012: EMA decision of of 20 November 2012 on the acceptance of a modification of an agreed paediatric investigation plan for methoxy polyethylene glycol-epoetin beta (Mircera), (EMEA-000172-PIP01-07-M01) (PDF/114.34 KB)

methoxy polyethylene glycol - epoetin beta (Mircera), (EMEA-000172-PIP01-07-M01 … methoxy polyethylene glycol - epoetin beta (Mircera), (EMEA-000172-PIP01-07-M01 … methoxy polyethylene glycol - epoetin beta (Mircera), (EMEA-000172-PIP01-07-M01 …

Adopted
First published: 04/01/2013
Last updated: 04/01/2013
EMA/646943/2012
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P/26/2009: European Medicines Agency decision of 23 February 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a waiver for methoxy polyethylene glycol - epoetin beta, MIRCERA (EMEA-000172-P... (PDF/42.88 KB)

methoxy polyethylene glycol - epoetin beta, MIRCERA (EMEA-000172-PIP01-07 … methoxy polyethylene glycol - epoetin beta, MIRCERA (EMEA-000172-PIP01-07 … methoxy polyethylene glycol - epoetin beta, MIRCERA, solution for …

Adopted
First published: 23/04/2009
Last updated: 23/04/2009
EMEA/99507/2009
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P/57/2008: European medicines agency decision of 20 July 2008 on the application for product specific waiver for Epoetin theta (EMEA-000219-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parli... (PDF/26.24 KB)

product 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 …

Adopted
First published: 08/09/2008
Last updated: 08/09/2008
EMEA/357430/2008

303 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)

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)

Questions and answers on the withdrawal of the marketing authorisation application for Epostim (epoetin alfa) (PDF/133.21 KB)

Questions and answers on the withdrawal of the marketing authorisation application for Ratioepo (epoetin theta) (PDF/65.8 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)

Public statement: European Medicines Agency starts review of the safety of epoetins (PDF/31.65 KB)

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

European Medicines Agency 2011 priorities for drug safety research: Epoetins and tumour progression, shortened survival, mortality and thromboembolic events (PDF/45.49 KB)

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

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)

P/0317/2017: EMA decision of 31 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for methoxy polyethylene glycol - epoetin beta (Mircera) (EMEA-000172-PIP01-07-M03) (PDF/131.07 KB)

P/0049/2017: EMA decision of 6 March 2017 on the refusal of a modification of an agreed paediatric investigation plan for methoxy polyethylene glycol - epoetin beta (Mircera), (EMEA-000172-PIP01-07-M02) (PDF/103.92 KB)

P/0263/2012: EMA decision of of 20 November 2012 on the acceptance of a modification of an agreed paediatric investigation plan for methoxy polyethylene glycol-epoetin beta (Mircera), (EMEA-000172-PIP01-07-M01) (PDF/114.34 KB)

P/26/2009: European Medicines Agency decision of 23 February 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a waiver for methoxy polyethylene glycol - epoetin beta, MIRCERA (EMEA-000172-P... (PDF/42.88 KB)

P/57/2008: European medicines agency decision of 20 July 2008 on the application for product specific waiver for Epoetin theta (EMEA-000219-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parli... (PDF/26.24 KB)