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Janssen-Cilag Ltd

50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG, UK
Telephone: +44 1494 567 567
Fax: +44 1494 567 568
Medical Information Direct Line: +353 1 800 709 122
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +353 1 620 2300
Medical Information Facsimile: +44 (0) 1494 567 445
Summary of Product Characteristics last updated on medicines.ie: 12/10/2017
SPC TREVICTA 175 mg, 263 mg, 350 mg, 525 mg prolonged release suspension for injection

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 12/10/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   14-Sep-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Changes to Section 4.8 to align with Xeplion SmPC

Updated on 22/09/2016 and displayed until 12/10/2017
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   17-Sep-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

In section 5.1 (Pharmacodynamic properties), update to add relapse data.
Updated on 08/06/2016 and displayed until 22/09/2016
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Paliperidone palmitate