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Opinion/decision on a Paediatric investigation plan (PIP): Sebivo, telbivudine

Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastroentology-Hepatology, PIP number: EMEA-000065-PIP01-07-M05, decision date: 07/06/2017, Last updated: 25/07/2017, compliance check: X

investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M05 … investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M05 … investigation plan for telbivudine (Sebivo), film-coated tablet, oral …
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Human medicine European public assessment report (EPAR): Sebivo

telbivudine, Hepatitis B, Chronic
Date of authorisation: 24/04/2007, Revision: 20, Authorised, Last updated: 29/05/2018

Sebivo EPAR Summary update R 23 … summary for the public Sebivo telbivudine This is a … assessment report (EPAR) for Sebivo. It explains how the Committee …
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Sebivo-H-C-713-R-0023 : EPAR - Assessment Report - Renewal (PDF/484.18 KB)

Assessment report Sebivo telbivudine Procedure … marketing authorisation for Sebivo International non-proprietary … marketing authorisation for Sebivo Page 3/39 CHMP …

Adopted
First published: 18/07/2012
Last updated: 18/07/2012
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Sebivo-H-C-PSUSA-2880-201608 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/68.75 KB)

Sebivo, INN-telbivudine 30 … Sebivo-H-C-PSUSA-2880-201608 : EPAR - Scientific conclusions … Sebivo-H-C-PSUSA-2880-201608 : EPAR - Scientific conclusions …

First published: 05/07/2017
Last updated: 05/07/2017
EMA/413022/2017
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Sebivo : EPAR - Product Information (PDF/792.79 KB)

Sebivo, INN-telbivudine 1 … THE MEDICINAL PRODUCT Sebivo 600 mg film-coated tablets … Therapeutic indications Sebivo is indicated for the treatment …

First published: 12/10/2009
Last updated: 29/05/2018
Bulgarian
(PDF/892.03 KB)

Croatian
(PDF/839.14 KB)

Czech
(PDF/831.38 KB)

Danish
(PDF/810.19 KB)

Dutch
(PDF/764.42 KB)

Estonian
(PDF/763.83 KB)

Finnish
(PDF/800.98 KB)

French
(PDF/844.33 KB)

German
(PDF/822.84 KB)

Greek
(PDF/879.08 KB)

Hungarian
(PDF/791.46 KB)

Icelandic
(PDF/749.59 KB)

Italian
(PDF/765.13 KB)

Latvian
(PDF/784.34 KB)

Lithuanian
(PDF/813.43 KB)

Maltese
(PDF/938.05 KB)

Norwegian
(PDF/769.01 KB)

Polish
(PDF/843.02 KB)

Portuguese
(PDF/754.8 KB)

Romanian
(PDF/862.98 KB)

Slovak
(PDF/901.51 KB)

Slovenian
(PDF/785 KB)

Spanish
(PDF/755.57 KB)

Swedish
(PDF/800.83 KB)
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Sebivo : EPAR - Scientific Discussion (PDF/277 KB)

Sebivo, INN-Telbivudine 1/45 … marketing authorisation of Sebivo is made under Article 8.3 … aspects Introduction Sebivo an immediate release dosage …

First published: 08/05/2007
Last updated: 08/05/2007
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Sebivo : EPAR - Assessment Report - Variation (PDF/575.62 KB)

Sebivo P46-057 AR 30 Churchill … regulation (EC) No 1901/2006 Sebivo International non-proprietary … the final report for the SEBIVO Study CLDT600A2104, an open-label …

Adopted
First published: 03/02/2015
Last updated: 03/02/2015
EMA/760212/2014
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Sebivo : EPAR - All Authorised presentations (PDF/12.02 KB)

Sebivo, INN-telbivudine 1/1 EU … Package size EU/1/07/388/001 Sebivo 600 mg Film-coated tablet … tablets EU/1/07/388/002 Sebivo 600 mg Film-coated tablet …

First published: 21/10/2009
Last updated: 21/10/2009
Bulgarian
(PDF/81.58 KB)

Croatian
(PDF/40.2 KB)

Czech
(PDF/78.76 KB)

Danish
(PDF/12.54 KB)

Dutch
(PDF/12.08 KB)

Estonian
(PDF/12.75 KB)

Finnish
(PDF/12.42 KB)

French
(PDF/12.7 KB)

German
(PDF/12.79 KB)

Greek
(PDF/77.41 KB)

Hungarian
(PDF/80.31 KB)

Icelandic
(PDF/13.36 KB)

Italian
(PDF/12.15 KB)

Latvian
(PDF/81.69 KB)

Lithuanian
(PDF/79.54 KB)

Maltese
(PDF/82.76 KB)

Norwegian
(PDF/13.39 KB)

Polish
(PDF/44.2 KB)

Portuguese
(PDF/12.63 KB)

Romanian
(PDF/77.72 KB)

Slovak
(PDF/80.17 KB)

Slovenian
(PDF/12.27 KB)

Spanish
(PDF/12.8 KB)

Swedish
(PDF/12.66 KB)
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Sebivo : EPAR - Summary for the public (PDF/49.85 KB)

Sebivo EPAR Summary update R 23 … summary for the public Sebivo telbivudine This is a … assessment report (EPAR) for Sebivo. It explains how the Committee …

First published: 27/02/2009
Last updated: 18/07/2012
Bulgarian
(PDF/149.63 KB)

Czech
(PDF/139.05 KB)

Danish
(PDF/50.5 KB)

Dutch
(PDF/50.97 KB)

Estonian
(PDF/49.78 KB)

Finnish
(PDF/110.43 KB)

French
(PDF/113.23 KB)

German
(PDF/111.46 KB)

Greek
(PDF/152.75 KB)

Hungarian
(PDF/74.72 KB)

Italian
(PDF/112.45 KB)

Latvian
(PDF/79.96 KB)

Lithuanian
(PDF/136.41 KB)

Maltese
(PDF/77.85 KB)

Polish
(PDF/139.29 KB)

Portuguese
(PDF/50.34 KB)

Romanian
(PDF/76.34 KB)

Slovak
(PDF/76.95 KB)

Slovenian
(PDF/73.95 KB)

Spanish
(PDF/110.4 KB)

Swedish
(PDF/109.67 KB)
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Sebivo : EPAR - Procedural steps taken before authorisation (PDF/22.74 KB)

Sebivo, INN-Telbivudine 1/2 ©EMEA … Medicines Agency (EMEA) for Sebivo (telbivudine) 600 mg film- coated … Marketing Authorisation to Sebivo on 22 February 2007. The …

First published: 08/05/2007
Last updated: 08/05/2007
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News: Public statement: Risk of peripheral neuropathy with Sebivo (telbivudine)

CHMP, Last updated: 14/02/2008

peripheral neuropathy with Sebivo (telbivudine … peripheral neuropathy with Sebivo (telbivudine …
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Sebivo : EPAR - Procedural steps taken and scientific information after authorisation (PDF/198.61 KB)

Sebivo, INN-telbivudine 30 … www.ema.europa.eu/contact Sebivo Procedural steps taken and … Package Leaflet). Sebivo EMA/356855/2018 Page 2/21 …

First published: 12/10/2009
Last updated: 29/05/2018
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CHMP post-authorisation summary of positive opinion for Sebivo (PDF/108.26 KB)

Sebivo R-23 SMOP 7 Westferry Circus … opinion1 (post authorisation) Sebivo telbivudine On 16 February … for the medicinal product Sebivo. The marketing authorisation …

Adopted
First published: 17/02/2012
Last updated: 17/02/2012
EMA/CHMP/123824/2012
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Public statement: Risk of peripheral neuropathy with Sebivo (telbivudine) (PDF/31.05 KB)

peripheral neuropathy with Sebivo (telbivudine) European … peripheral neuropathy with Sebivo (telbivudine) The European … the product information for Sebivo (telbivudine), from Novartis …

First published: 14/02/2008
Last updated: 14/02/2008
EMEA/60439/2008
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P/0152/2017: EMA decision of 7 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M05) (PDF/75.77 KB)

investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M05 … investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M05 … investigation plan for telbivudine (Sebivo), film-coated tablet, oral …

Adopted
First published: 25/07/2017
Last updated: 25/07/2017
EMA/305258/2017
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P/0006/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for telbivudine (Sebivo) (EMEA-000065-PIP01-07-M04) (PDF/125.86 KB)

investigation plan for telbivudine (Sebivo) (EMEA-000065-PIP01-07-M04 … investigation plan for telbivudine (Sebivo) (EMEA-000065-PIP01-07-M04 … investigation plan for telbivudine (Sebivo) (EMEA-000065-PIP01-07-M04 …

Adopted
First published: 19/02/2014
Last updated: 19/02/2014
EMA/784553/2013
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P/0236/2012: EMA decision of 22 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M03) (PDF/103.03 KB)

investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M03 … investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M03 … investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M03 …

Adopted
First published: 26/11/2012
Last updated: 26/11/2012
EMA/636818/2012
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P/203/2011: EMA decision of 31 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M02) (PDF/149.89 KB)

investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M02 … investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M02 … investigation plan for telbivudine (Sebivo), film-coated tablet, oral …

Adopted
First published: 03/10/2011
Last updated: 03/10/2011
EMA/505512/2011
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P/119/2010: European Medicines Agency decision of 9 July 2010 on the acceptance of a modification of an agreed paediatric investigation plan for telbivudine (Sebivo) (EMEA-000065-PIP01-07-M01) in accordance with Regulat... (PDF/120.23 KB)

investigation plan for telbivudine (Sebivo) (EMEA-000065-PIP01-07-M01 … investigation plan for telbivudine (Sebivo) (EMEA-000065-PIP01-07-M01 … investigation plan for telbivudine (Sebivo), oral solution, film-coated …

Adopted
First published: 28/07/2010
Last updated: 28/07/2010
EMA/349760/2010
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P/111/2008: European Medicines Agency decision of 1 December 2008 on the application for agreement of a Paediatric Investigation Plan for telbivudine (Sebivo), EMEA-000065-PIP01-07, in accordance with Regulation (EC) No ... (PDF/42.08 KB)

Investigation Plan for telbivudine (Sebivo), EMEA-000065-PIP01-07 … Investigation Plan for telbivudine (Sebivo), EMEA-000065-PIP01-07 … Investigation Plan for telbivudine (Sebivo), oral solution, film-coated …

Adopted
First published: 29/01/2009
Last updated: 29/01/2009
EMEA/622947/2008
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Human medicine European public assessment report (EPAR): Hepsera

adefovir dipivoxil, Hepatitis B, Chronic
Date of authorisation: 06/03/2003, Revision: 26, Authorised, Last updated: 08/08/2019
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Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 March 2018

European Medicines Agency, London, UK, from 05/03/2018 to 08/03/2018, Last updated: 05/03/2018
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 April 2017

European Medicines Agency, London, UK, from 03/04/2017 to 06/04/2017, Last updated: 13/03/2014
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Pharmacovigilance Risk Assessment Committee (PRAC): 27-30 November 2017

European Medicines Agency, London, UK, from 27/11/2017 to 30/11/2017, Last updated: 27/11/2017
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 April 2013

European Medicines Agency, London, UK, from 08/04/2013 to 11/04/2013, Last updated: 02/06/2012

110 results

Opinion/decision on a Paediatric investigation plan (PIP): Sebivo, telbivudine

Human medicine European public assessment report (EPAR): Sebivo

Sebivo-H-C-713-R-0023 : EPAR - Assessment Report - Renewal (PDF/484.18 KB)

Sebivo-H-C-PSUSA-2880-201608 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/68.75 KB)

Sebivo : EPAR - Product Information (PDF/792.79 KB)

Sebivo : EPAR - Scientific Discussion (PDF/277 KB)

Sebivo : EPAR - Assessment Report - Variation (PDF/575.62 KB)

Sebivo : EPAR - All Authorised presentations (PDF/12.02 KB)

Sebivo : EPAR - Summary for the public (PDF/49.85 KB)

Sebivo : EPAR - Procedural steps taken before authorisation (PDF/22.74 KB)

News: Public statement: Risk of peripheral neuropathy with Sebivo (telbivudine)

Sebivo : EPAR - Procedural steps taken and scientific information after authorisation (PDF/198.61 KB)

CHMP post-authorisation summary of positive opinion for Sebivo (PDF/108.26 KB)

Public statement: Risk of peripheral neuropathy with Sebivo (telbivudine) (PDF/31.05 KB)

P/0152/2017: EMA decision of 7 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M05) (PDF/75.77 KB)

P/0006/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for telbivudine (Sebivo) (EMEA-000065-PIP01-07-M04) (PDF/125.86 KB)

P/0236/2012: EMA decision of 22 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M03) (PDF/103.03 KB)

P/203/2011: EMA decision of 31 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M02) (PDF/149.89 KB)

P/119/2010: European Medicines Agency decision of 9 July 2010 on the acceptance of a modification of an agreed paediatric investigation plan for telbivudine (Sebivo) (EMEA-000065-PIP01-07-M01) in accordance with Regulat... (PDF/120.23 KB)

P/111/2008: European Medicines Agency decision of 1 December 2008 on the application for agreement of a Paediatric Investigation Plan for telbivudine (Sebivo), EMEA-000065-PIP01-07, in accordance with Regulation (EC) No ... (PDF/42.08 KB)

Human medicine European public assessment report (EPAR): Hepsera

Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 March 2018

Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 April 2017

Pharmacovigilance Risk Assessment Committee (PRAC): 27-30 November 2017

Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 April 2013