198 results
Keyword Tramadol Remove keyword
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Orphan designation: Refusal of orphan designation for the treatment of painful HIV-associated neuropathy
Date of refusal of designation: 21/09/2006, Negative, Last updated: 19/07/2007Tramadol hydrochloride Overview On … on orphan designation of tramadol hydrochloride for the treatment … justification has been provided that tramadol hydrochloride may be of significant … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tramadol, paracetamol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: Tramadol / paracetamol, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 07/09/2009, Last updated: 22/10/2009, Compliance check: XTramadol / paracetamol Pain … Key facts Tramadol paracetamol PainW/185/2009 Tramadol / paracetamol Film-coated … product specific waiver for tramadol / paracetamol (EMEA-000598-PIP01-09 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, Tramadol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001887-PIP01-15, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Solution for infusion, Granules for oral solution, Concentrate for solution for infusion
Decision date: 14/06/2016, Last updated: 26/08/2016, Compliance check: XKey facts Ibuprofen Tramadol PainP/0153/2016EMEA-001887-PIP01-15 … specific waiver for ibuprofen / tramadol (EMEA-001887-PIP01-15) PDF … specific waiver for ibuprofen / tramadol (EMEA-001887-PIP01-15) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tramadol hydrochloride, paracetamol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: Tramadol hydrochloride, Paracetamol, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 23/12/2009, Last updated: 25/01/2010, Compliance check: XTramadol hydrochloride, Paracetamol P … Key facts Tramadol hydrochloride paracetamol … paracetamol PainP/261/2009Tramadol hydrochloride, Paracetamol … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tramadol hydrochloride, paracetamol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: Tramadol hydrochloride, Paracetamol, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 23/12/2009, Last updated: 25/01/2010, Compliance check: XTramadol hydrochloride, Paracetamol P … Key facts Tramadol hydrochloride paracetamol … paracetamol PainP/260/2009Tramadol hydrochloride, Paracetamol … -
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Opinion/decision on a Paediatric investigation plan (PIP): Dexketoprofen (trometamol), Tramadol hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001302-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 22/10/2012, Last updated: 27/11/2012, Compliance check: XDexketoprofen (trometamol) Tramadol hydrochloride PainP/0244/2012EMEA-001302-PIP01-12 … dexketoprofen (trometamol) / tramadol (hydrochloride) (EMEA-001302-PIP01-12 … dexketoprofen (trometamol) / tramadol (hydrochloride) (EMEA-001302-PIP01-12) 7 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Co-crystal of tramadol (hydrochloride), Celecoxib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001279-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 24/08/2012, Last updated: 18/09/2012, Compliance check: Xtive substance Co-crystal of tramadol (hydrochloride) Celecoxib … waiver for co-crystal of tramadol (hydrochloride) / celecoxib … waiver for co-crystal of tramadol (hydrochloride) / celecoxib (EMEA-001279-PIP01-12 … -
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Referral: GVK Biosciences
esomeprazole magnesium, candesartan cilexetil, nebivolol, desloratadine, donepezil, repaglinide, candesartan, esomeprazole, alendronic acid, ropinirole, cefpodoxime, quetiapine, trimetazidine, bosentan, tramadol, paracetamol, escitalopram, trimetazidine hydrochloride, entacapone, valsartan, hydrochlorothiazide, donepezil hydrochloride, ropinirole hydrochloride, clopidogrel hydrochloride, escitalopram oxalate, metformin hydrochloride, trimetazidine dihydrochloride, rizatriptan benzoate, metformin, fluconazole, eletriptan, rizatriptan, ebastine, ibuprofen, desmopressin, aciclovir, levetiracetam, irbesartan, venlafaxine, ciprofloxacin, cefpodoxime proxetil, tacrolimus, fexofenadine hydrochloride, phenoxymethylpenicillin, amlodipine besilate, metoclopramide, clopidogrel, levodopa, carbidopa, entacapone, atorvastatin, telmisartan, clindamycin hydrochloride, metoclopramide hydrochloride, clonazepam, clobazam, dexamethasone, thiamine hydrochloride, tramadol hydrochloride, pioglitazone, dipyridamole, fexofenadine, amlodipine, pantoprazole, hydrocortisone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/05/2015, EC decision date: 16/07/2015, Last updated: 04/08/2015acid ropinirole cefpodoxime quetiapine trimetazidine bosentan tramadol paracetamol escitalopram trimetazidine … hydrochloride clonazepam clobazam dexamethasone thiamine hydrochloride tramadol hydrochloride pioglitazone … -
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Human medicine European public assessment report (EPAR): Dynastat
parecoxib sodium, Pain, Postoperative
Date of authorisation: 22/03/2002, Revision: 32, Authorised, Last updated: 17/08/2022ibuprofen, ketorolac, morphine, tramadol and valdecoxib. Dynastat … -
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Veterinary medicine European public assessment report (EPAR): Mirataz
mirtazapine, Cats
Date of authorisation: 10/12/2019, Revision: 2, Authorised, Last updated: 02/02/2021medicines cyproheptadine, tramadol or monoamine oxidase inhibitors … treated with cyproheptadine, tramadol or monoamine oxidase inhibitors … treated with cyproheptadine, tramadol or monoamine oxidase inhibitors … -
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Press release: Modified-release paracetamol-containing products to be suspended from EU market
CMDh, Last updated: 15/12/2017with the opioid medicine tramadol, should be suspended. The … with the opioid medicine tramadol, should be suspended. The … with another painkiller, tramadol. These combination products … -
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Orphan designation: Riluzole for: Treatment of traumatic spinal cord injury
Date of designation: 16/12/2014, Positive, Last updated: 27/02/2015lamotrigine, pregabalin and tramadol). Patients with spinal cord … lamotrigine, pregabalin and tramadol). Patients with spinal cord … -
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Referral: Paracetamol modified-release
paracetamol, associated names: Alvedon, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2017, EC decision date: 19/02/2018, Last updated: 01/03/2018with the opioid medicine tramadol, should be suspended. The … with another painkiller, tramadol. These combination products … paracetamol (alone or combined with tramadol) is being removed from the … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2017
PRAC, Last updated: 01/12/2017modified-release paracetamol with tramadol. More information is provided … -
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National expert: Hugues Malonne, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 81.15 KB | PDF
- Curriculum Vitae - 35.23 KB | PDF
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National expert: Monika Trojan, The Office for Registration of Medicinal Products, Medical Devices and Biocides (updated)
- Declaration of interests - 80.29 KB | PDF
- Curriculum Vitae - 16.81 KB | PDF
University project concerning tramadol and magnesium lactate Memberships … medicinal product containing tramadol performed by Warsaw Medical … -
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National expert: Antonio Portolés, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 82.88 KB | PDF
- Curriculum Vitae - 43.11 KB | PDF
Ibuprofen / acetaminophen or tramadol analgesia 02/2021-07/2022 … -
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National expert: Roberto Villa, Ministry for Health (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 22.06 KB | PDF
postoperative analgesia of tramadol in cats. Research in Veterinary … Clinical pharmacokinetics of tramadol and main metabolites in horses … -
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National expert: Camilla Aertebjerg Baek, Danish Medicines Agency (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 20.49 KB | PDF
monoamine reuptake inhibitor tramadol. Neuropharmacology 2007. Camilla … -
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National expert: Nadine Petitpain, Ministry for Health (updated)
- Declaration of interests - 81.19 KB | PDF
- Curriculum Vitae - 28.16 KB | PDF
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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): Adasuve
loxapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 20/02/2013, Revision: 14, Authorised, Last updated: 14/11/2022 -
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Human medicine European public assessment report (EPAR): Mysimba
bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight
Date of authorisation: 26/03/2015,, Revision: 23, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Xyrem
sodium oxybate, Cataplexy; Narcolepsy
Date of authorisation: 13/10/2005, Revision: 36, Authorised, Last updated: 12/10/2022 -
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (updated)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015,
, Revision: 15, Authorised, Last updated: 12/01/2023