52 results
Keyword Hydromorphone Remove keyword
-
List item
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: 06/06/2011related medicines oxycodone and hydromorphone, all of which work by attaching … with morphine, two used with hydromorphone and four used with oxycodone … related medicines oxycodone and hydromorphone, all of which work by attaching … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Hydromorphone (hydrochloride), naloxone (hydrochloride)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001762-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release capsule, Capsule, hard
Decision date: 02/10/2015, Last updated: 17/12/2015, Compliance check: XKey facts Hydromorphone (hydrochloride) naloxone … product specific waiver for hydromorphone (hydrochloride) / naloxone … product-specific waiver: Hydromorphone (hydrochloride) / naloxone … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Hydromorphone (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-001699-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 Hydromorphone (hydrochloride) naloxone … product-specific waiver for hydromorphone (hydrochloride) / naloxone … product-specific waiver: Hydromorphone (hydrochloride) / naloxone … -
List item
Human medicine European public assessment report (EPAR): Instanyl (updated)
Fentanyl citrate, Pain; Cancer
Date of authorisation: 20/07/2009, Revision: 35, Authorised, Last updated: 17/01/2023daily, at least 8 mg of oral hydromorphone daily or an equianalgesic … -
List item
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: 23/07/2010related medicines oxycodone and hydromorphone. These medicines were reviewed … medicines oxycodone and hydromorphone. These medicines were reviewed … -
List item
Human medicine European public assessment report (EPAR): Effentora
fentanyl, Pain; Cancer
Date of authorisation: 04/04/2008, Revision: 28, Authorised, Last updated: 11/11/2022daily, at least 8 mg of oral hydromorphone daily or an equianalgesic … -
List item
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 -
List item
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
-
List item
Human medicine European public assessment report (EPAR): Suboxone (updated)
buprenorphine, naloxone, Opioid-Related Disorders
Date of authorisation: 26/09/2006, Revision: 21, Authorised, Last updated: 17/01/2023 -
List item
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 -
List item
Human medicine European public assessment report (EPAR): Cosentyx (updated)
Secukinumab, Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing
Date of authorisation: 14/01/2015, Revision: 28, Authorised, Last updated: 02/02/2023 -
List item
Human medicine European public assessment report (EPAR): Noxafil (updated)
posaconazole, Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis
Date of authorisation: 25/10/2005, Revision: 35, Authorised, Last updated: 16/01/2023 -
List item
Veterinary medicine European public assessment report (EPAR): Cerenia
maropitant citrate, Dogs; Cats
Date of authorisation: 28/09/2006, Revision: 21, Authorised, Last updated: 18/08/2021 -
List item
Human medicine European public assessment report (EPAR): Zalviso
sufentanil, Pain, Postoperative
Date of authorisation: 18/09/2015, Revision: 7, Withdrawn, Last updated: 27/09/2022 -
List item
Human medicine European public assessment report (EPAR): Kapruvia
difelikefalin, Pruritus
Date of authorisation: 25/04/2022,, Revision: 1, Authorised, Last updated: 21/07/2022
-
List item
Human medicine European public assessment report (EPAR): Emend
Aprepitant, Vomiting; Postoperative Nausea and Vomiting; Cancer
Date of authorisation: 11/11/2003, Revision: 29, Authorised, Last updated: 31/08/2022 -
List item
Human medicine European public assessment report (EPAR): Isentress
Raltegravir, HIV Infections
Date of authorisation: 19/12/2007,
, Revision: 42, Authorised, Last updated: 20/10/2022
-
List item
Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,
, , Revision: 35, Authorised, Last updated: 03/02/2023
-
List item
Human medicine European public assessment report (EPAR): Unituxin
Dinutuximab, Neuroblastoma
Date of authorisation: 14/08/2015, Revision: 3, Withdrawn, Last updated: 28/04/2017 -
List item
Human medicine European public assessment report (EPAR): Nuedexta
dextromethorphan, quinidine, Neurobehavioral Manifestations
Date of authorisation: 24/06/2013, Revision: 2, Withdrawn, Last updated: 11/03/2016 -
List item
Withdrawn application: Effentora
fentanyl, date of withdrawal: 11/07/2013, Post-authorisation, Last updated: 29/08/2013 -
List item
Withdrawn application: Oxapex
date of withdrawal: 04/12/2014, Initial authorisation, Last updated: 29/07/2015 -
List item
Referral: Durogesic and associated names
fentanyl, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/07/2016, EC decision date: 22/09/2016, Last updated: 19/10/2016 -
List item
Referral: Fentanyl-ratiopharm_TTS
fentanyl, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/07/2007, EC decision date: 23/10/2007, Last updated: 14/12/2007 -
List item
Referral: Fentanyl-ratiopharm Matrixpflaster
fentanyl, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/07/2007, EC decision date: 23/10/2007, Last updated: 14/12/2007