111 results
Keyword Oxycodone Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): morphine, oxycodone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001281-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 21/01/2013, Last updated: 03/04/2013, Compliance check: XKey facts morphine oxycodone PainP/0007/2013EMEA-001281-PIP01-12 … product-specific waiver for morphine / oxycodone (EMEA-001281-PIP01-12) PDF … specific waiver for morphine / oxycodone (EMEA-001281-PIP01-12 … -
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Referral: Oxynal Targin and associated names
oxycodone hydrochloride, naloxone hydrochloride, Article 13 referrals
Status: European Commission final decision, opinion/position date: 23/10/2014, EC decision date: 22/12/2014, Last updated: 27/01/2015contain two active substances: oxycodone hydrochloride, an opioid … by blocking the action of oxycodone at opioid receptors found … contain two active substances: oxycodone hydrochloride, an opioid … -
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Referral: Modified-released oral opioids
hydromorphone, morphine, oxycodone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/11/2010, EC decision date: 20/04/2011, Last updated: 06/06/2011and the related medicines oxycodone and hydromorphone, all of … hydromorphone and four used with oxycodone. The CHMP used the results … and the related medicines oxycodone and hydromorphone, all of … -
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Opinion/decision on a Paediatric investigation plan (PIP): Oxycodone (hydrochloride), naloxone (hydrochloride)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001700-PIP01-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 06/03/2015, Last updated: 06/07/2015, Compliance check: XKey facts Oxycodone (hydrochloride) naloxone … product-specific waiver for oxycodone (hydrochloride) / naloxone … product-specific waiver: Oxycodone (hydrochloride) / naloxone … -
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Human medicine European public assessment report (EPAR): Instanyl (updated)
Fentanyl citrate, Pain; Cancer
Date of authorisation: 20/07/2009, Revision: 35, Authorised, Last updated: 17/01/2023per hour, at least 30 mg oxycodone daily, at least 8 mg of oral … -
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National expert: Xiaofei Liu, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 80.79 KB | PDF
- Curriculum Vitae - 18.09 KB | PDF
tapentadol vs. extended-release oxycodone/naloxone. BMC Anesthesiol. 2017 Jul … -
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National expert: Pal Riba, National Institute of Pharmacy and Nutrition (updated)
- Declaration of interests - 80.17 KB | PDF
- Curriculum Vitae - 30.33 KB | PDF
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Human medicine European public assessment report (EPAR): Effentora
fentanyl, Pain; Cancer
Date of authorisation: 04/04/2008, Revision: 28, Authorised, Last updated: 11/11/2022per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral … -
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Human medicine European public assessment report (EPAR): PecFent
fentanyl, Pain; Cancer
Date of authorisation: 31/08/2010, Revision: 23, Authorised, Last updated: 08/11/2022 -
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National expert: Paula Contreras Alarcón, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 80.94 KB | PDF
- Curriculum Vitae - 17.09 KB | PDF
Mundipharma Pharmaceuticals S.L Oxycodone Hydrocloride Pain 2.3 Strategic … -
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Press release: European Medicines Agency concludes review of modified-release oral opioids of the WHO level III scale for the management of pain
Last updated: 23/07/2010and the related medicines oxycodone and hydromorphone. These … and the related medicines oxycodone and hydromorphone. These … -
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Human medicine European public assessment report (EPAR): Darunavir Krka d.d. (updated)
darunavir, HIV Infections
Date of authorisation: 18/01/2018,
, Revision: 8, Withdrawn, Last updated: 03/02/2023
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Human medicine European public assessment report (EPAR): Pregabalin Mylan (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 24/06/2015,, Revision: 16, Authorised, Last updated: 13/01/2023
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Human medicine European public assessment report (EPAR): Pregabalin Accord (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 28/08/2015,, Revision: 15, Authorised, Last updated: 09/01/2023
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH (updated)
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 14, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz (updated)
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 15, Authorised, Last updated: 05/01/2023
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Human medicine European public assessment report (EPAR): Rizmoic
Naldemedine tosilate, Constipation
Date of authorisation: 18/02/2019,
, Revision: 7, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Darunavir Mylan
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 12, Authorised, Last updated: 04/11/2022
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 17/07/2015,, Revision: 14, Authorised, Last updated: 21/11/2022
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva k.s.
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 27/02/2017,, Revision: 13, Authorised, Last updated: 18/11/2022
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Human medicine European public assessment report (EPAR): Rezolsta
darunavir, cobicistat, HIV Infections
Date of authorisation: 19/11/2014, Revision: 15, Authorised, Last updated: 13/12/2022 -
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Human medicine European public assessment report (EPAR): Darunavir Krka
darunavir, HIV Infections
Date of authorisation: 26/01/2018,, Revision: 8, Authorised, Last updated: 23/11/2022
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Human medicine European public assessment report (EPAR): Melatonin Neurim
melatonin, Sleep Initiation and Maintenance Disorders
Date of authorisation: 07/11/2022, Authorised, Last updated: 25/11/2022 -
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Human medicine European public assessment report (EPAR): Dzuveo
sufentanil citrate, Pain
Date of authorisation: 25/06/2018, Revision: 5, Authorised, Last updated: 26/10/2022 -
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Human medicine European public assessment report (EPAR): Symtuza
darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/09/2017, Revision: 16, Authorised, Last updated: 13/12/2022