Erstellt am 01 Mar 2019 11:19
Zuletzt geändert: 01 Mar 2019 14:31
Europaweit zugelassen
- Gelbe Liste: Trientin
- EPAR der EMA für Cuprior
- Public summary of opinion on orphan Designation: Trientine tetrahydrochloride for the treatment of Wilson's disease
Please note that this product (marketed as Cuprior) was withdrawn from the Community Register of designated Orphan Medicinal Products by the European Commission in July 2017, at the time of the granting of a marketing authorisation.
On 19 March 2015, orphan designation (EU/3/15/1471) was granted by the European Commission to GMP-Orphan SAS, France, for trientine tetrahydrochloride for the treatment of Wilson's disease.
The sponsorship was transferred to Univar BV, The Netherlands, in July 2013.
The active substance, trientine dihydrochloride is authorised in the United Kingdom, in Wilson’s patients who are intolerant of penicillamine therapy.
The product authorised in the United Kingdom is exported to Germany, France, Greece, Norway, Switzerland, Austria and Ireland, however supply is restricted to named patients only.
Trientine dihydrochloride has been granted marketing authorisation in the United States for treatment of Wilson’s disease in patients who are intolerant of penicillamine.
In Europa im Wege der gegenseitigen Anerkennung zugelassen:
Arznei-News
Handelspräparate im Ausland:
Trientine hydrochloride is the generic ingredient in two branded drugs marketed by Aton and Watson Labs Teva, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.
- UK Medicines and Healthcare products Regulatory Agency (MHRA): Trientine Dihydrochloride 300 mg Capsules
- NHS England Evidence review: Trientine dihydrochloride for Wilson’s disease
- UK Specialist Pharmacy Service: Trientine:
Trientine tetrahydrochloride is expected to work in the same way as trientine dihydrochloride, by attaching to the free copper in the body and forming a compound that can be excreted in the urine by the kidneys.
01. Trientine dihydrochloride has been available as an unlicensed product in the UK since 1995.
02. Univar plc is the UK manufacturer and supplier of 300 mg Trientine Dihydrochloride capsules for the treatment of Wilson’s disease. Univar is a chemical supplier and trientine dihydrochloride is an unlicensed product.
03. Cuprior will be available as 150 mg tablets (trientine base)
USA:
- Syprine
- ANDA (abbreviated new drug application) approvals:
- Trientine Hydrochloride - Watson Laboratories, Inc.
- Trientine Hydrochloride - AMNEAL PHARMS LLC
- Trientine Hydrochloride - NAVINTA LLC
- The Office of Bioequivalence has determined your Trientine Hydrochloride Capsules USP, 250 mg, to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), Syprine Capsules, 250 mg, of Aton Pharma, Inc. …
Andere, z.T. auch nicht mehr aktiv verwendete Namen: Cuprid; Metalite; Syprine; Tecza; Teta; TJA 250; Trien; Triestine.
Dazu Artikel bei Wilsons disease.org.
Studien
Patienten, Selbsthilfe und Kosten
- Morbus Wilson Forum: Trientine: Kosten und KK-Übernahme??? Diskussion aus 2016 - zeigt die unglaublichen Preissprünge bei diesem Medikament…
- Outcry as cost to NHS of Wilson’s Disease treatment escalates by 600%
- Merck KGaA, Darmstadt, Sigma-Aldrich, Inc: Trientine hydrochloride
- Wilsonsdisease.org.uk
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