40 results
Keyword Chloroprocaine Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Chloroprocaine hydrochloride
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Anaesthesiology
PIP number: Chloroprocaine hydrochloride, Route(s) of administration: Intrathecal use, Pharmaceutical form(s): Solution for injection
Decision date: 30/10/2009, Last updated: 07/12/2009, Compliance check: XChloroprocaine hydrochloride Anaesthesiolog … Key facts Chloroprocaine hydrochloride AnaesthesiologyP/217/2009Chloroprocaine … product specific waiver for chloroprocaine hydrochloride (EMEA-000639-PIP01-09 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Chloroprocaine hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Anaesthesiology
PIP number: EMEA-000639-PIP03-16-M01, Route(s) of administration: Perineural use, Pharmaceutical form(s): Solution for injection
Decision date: 04/12/2020, Last updated: 31/03/2020, Compliance check: XKey facts Ampres Chloroprocaine hydrochloride AnaesthesiologyP/0382/2019EMEA-000639-PIP03-16-M01 … paediatric investigation plan for chloroprocaine (hydrochloride) (Ampres … Chloroprocaine hydrochloride … -
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Opinion/decision on a Paediatric investigation plan (PIP): Chloroprocaine hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Anaesthesiology
PIP number: EMEA-000639-PIP02-09-M02, Route(s) of administration: Intrathecal use, Pharmaceutical form(s): Solution for injection
Decision date: 27/10/2015, Last updated: 06/01/2016, Compliance check: XKey facts Chloroprocaine hydrochloride AnaesthesiologyP/0231/2015EMEA-000639-PIP02-09-M02 … paediatric investigation plan for chloroprocaine (hydrochloride), (EMEA-000639-PIP02-09-M02 … paediatric investigation plan for chloroprocaine (hydrochloride), (EMEA-000639-PIP02-09-M02 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Chloroprocaine hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Anaesthesiology
PIP number: EMEA-000639-PIP06-20, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye gel
Decision date: 17/06/2020, Last updated: 04/03/2021, Compliance check: XKey facts Ampres Chloroprocaine hydrochloride AnaesthesiologyP/0216/2020EMEA-000639-PIP06-20 … product specific waiver for chloroprocaine (hydrochloride) (Ampres … product specific waiver for chloroprocaine (hydrochloride) (Ampres … -
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Opinion/decision on a Paediatric investigation plan (PIP): Chloroprocaine hydrochloride
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Anaesthesiology
PIP number: EMEA-000639-PIP04-19, Route(s) of administration: Epidural use, Pharmaceutical form(s): Solution for injection
Decision date: 06/01/2020, Last updated: 04/06/2020, Compliance check: XKey facts Ampres Chloroprocaine hydrochloride AnaesthesiologyP/0010/2020EMEA-000639-PIP04-19 … product specific waiver for chloroprocaine (hydrochloride) (Ampres … Chloroprocaine hydrochloride … -
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Opinion/decision on a Paediatric investigation plan (PIP): Chloroprocaine hydrochloride
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Anaesthesiology
PIP number: EMEA-000639-PIP05-19, Route(s) of administration: Ocular use, Pharmaceutical form(s): Gel
Decision date: 06/01/2020, Last updated: 04/06/2020, Compliance check: XKey facts Ampres Chloroprocaine hydrochloride AnaesthesiologyP/0009/2020EMEA-000639-PIP05-19 … product specific waiver for chloroprocaine (hydrochloride) (Ampres … Chloroprocaine hydrochloride … -
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National expert: Gerhard Garhöfer, Austrian Medicines and Medical Devices Agency (updated)
- Declaration of interests - 82.88 KB | PDF
- Curriculum Vitae - 16.97 KB | PDF
11/2019-(current) Sintetica Chloroprocaine Eye Drops topical anaesthesia … -
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National expert: Martin Hohenegger, Austrian Medicines and Medical Devices Agency (updated)
- Declaration of interests - 81.16 KB | PDF
- Curriculum Vitae - 19.01 KB | PDF
09/2020-09/2020 Sintetica SA Chloroprocaine 3% Gel Eye Drops Local … -
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National expert: Steffen Rex, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 82.35 KB | PDF
- Curriculum Vitae - 44.83 KB | PDF
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Paediatric Committee (PDCO): 17-20 May 2022
Virtual meeting, from 17/05/2022 to 20/05/2022, Last updated: 21/07/2022 -
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Paediatric Committee (PDCO): 21-24 June 2022
Virtual meeting, from 21/06/2022 to 24/06/2022, Last updated: 21/06/2022 -
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PDCO: Agendas, minutes and reports (updated)
Last updated: 17/01/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 24-27 October 2022
European Medicines Agency, Amsterdam, the Netherlands, from 24/10/2022 to 27/10/2022, Last updated: 04/07/2022 -
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PDCO: meeting archive 2015-2017
Last updated: 19/04/20228 2.1.1. Chloroprocaine Hydrochloride - EMEA-000639-PIP03-16 …
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Paediatric Committee (PDCO): 21-24 March 2017
European Medicines Agency, London, UK, from 21/03/2017 to 24/03/2017, Last updated: 03/07/2014 -
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Paediatric Committee (PDCO): 12-15 December 2017
European Medicines Agency, London, UK, from 12/12/2017 to 15/12/2017, Last updated: 03/07/20148 2.1.1. Chloroprocaine Hydrochloride - EMEA-000639-PIP03-16 … -
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Paediatric Committee (PDCO): 7-10 November 2017
European Medicines Agency, London, UK, from 07/11/2017 to 10/11/2017, Last updated: 03/07/2014 -
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Paediatric Committee (PDCO): 21-24 February 2017
European Medicines Agency, London, UK, from 21/02/2017 to 24/02/2017, Last updated: 03/07/2014 -
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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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Committee for Orphan Medicinal Products (COMP): 10-12 May 2022
European Medicines Agency, Amsterdam, the Netherlands, from 10/05/2022 to 12/05/2022, Last updated: 10/12/2021 -
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Paediatric Committee (PDCO): 9-11 September 2015
European Medicines Agency, London, UK, from 09/09/2015 to 11/09/2015, Last updated: 22/02/2013 -
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Press release: Meeting highlights from the Paediatric Committee: 16 - 18 September 2009
PDCO, Last updated: 24/09/2009request for waiver for: Chloroprocaine hydrochloride, from Sintetica … -
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Paediatric Committee (PDCO): 14-16 July 2010
European Medicines Agency, London, UK, from 14/07/2010 to 16/07/2010, Last updated: 16/02/2010of ophthalmology; • Chloroprocaine hydrochloride, from Sintetica … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 - 27 October 2022
PRAC, Last updated: 28/10/2022