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News: Public Statement: European Medicines Agency starts review of the safety of epoetins

Last updated: 28/04/2007

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

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)

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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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

Public Statement: Epoetins and the risk of tumour growth … Public Statement: Epoetins and the risk of tumour growth …
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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
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P/55/2008: European medicines agency decision of 20 July 2008 on the application for product specific waiver for Epoetin theta (EMEA-000217-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parlia... (PDF/27.18 KB)

product 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 …

Adopted
First published: 08/09/2008
Last updated: 08/09/2008
EMEA/357428/2008
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P/56/2008: European medicines agency decision of 20 July 2008 on the application for product specific waiver for Epoetin theta (EMEA-000218-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parlia... (PDF/26.36 KB)

product 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 …

Adopted
First published: 08/09/2008
Last updated: 08/09/2008
EMEA/357429/2008
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Similar biological medicinal products containing recombinant erythropoietins

Last updated: 23/07/2018

Keywords Erythropoietin, Epoetin, recombinant biological medicinal … recombinant human erythropoietin (epoetin)-containing medicinal products claiming … expression system and termed epoetin. All …
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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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National expert: Dimitar Roussinov, Bulgarian Drug Agency (updated)
Declaration of interests - 80.55 KB | PDF

Curriculum Vitae - 73.15 KB | PDF

Last updated: 02/07/2020
Hospira UK Limited Retacrit (epoetin zeta) Post-Autorization Safety …
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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

456 results

News: Public Statement: European Medicines Agency starts review of the safety of epoetins

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)

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)

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)

P/55/2008: European medicines agency decision of 20 July 2008 on the application for product specific waiver for Epoetin theta (EMEA-000217-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parlia... (PDF/27.18 KB)

P/56/2008: European medicines agency decision of 20 July 2008 on the application for product specific waiver for Epoetin theta (EMEA-000218-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parlia... (PDF/26.36 KB)

Similar biological medicinal products containing recombinant erythropoietins

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

National expert: Dimitar Roussinov, Bulgarian Drug Agency (updated)

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