TREVICTA 175 mg, 263 mg, 350 mg, 525 mg prolonged release suspension for injection
*Company:
Janssen Sciences IrelandStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 29 May 2023
File name
20230525 Type II EN Trevicta-pronoged-release suspension-PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Approval of variation type II EMEA/H/C/XXXX/WS/2405 AE updates + editorial changes
Updated on 29 May 2023
File name
20230525 Type II WS2405 EN Trevicta-prolonged-release suspension-SmPC.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.8 - Undesirable effects
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Approval of variation type II EMEA/H/C/XXXX/WS/2405 AE updates + editorial changes
Updated on 25 May 2021
File name
NI & IE SPC-Trevicta-clean-approved-April 2021.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.8 Undesirable effects
Paliperidone is the active metabolite of risperidone, therefore, the adverse reaction profiles of these compounds (including both the oral and injectable formulations) are relevant to one another. In addition to the above adverse reactions, the following adverse reactions have been noted with the use of risperidone products and can be expected to occur with INVEGA.
Psychiatric disorders: sleep-related eating disorder
Nervous system disorders: cerebrovascular disorder
Eye disorders: floppy iris syndrome (intraoperative)
Respiratory, thoracic and mediastinal disorders: rales
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome/toxic epidermal necrolysis
Updated on 25 May 2021
File name
NI & IE PIL-Trevicta-clean-approved-April 2021.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 20 November 2019
File name
Trevicta-C06-SPC-CD19Nov19-clean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 October 2018
File name
Trevicta-PIL-C04-13Sep18-clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 22 October 2018
File name
Trevicta-C05-SPC-13Sep18-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of information regarding concomitant use with psychostimulants (Section 4.4 and 4.5). Addition of a new side-effect catatonia categorised as ‘rare’ (Section 4.8).
Updated on 27 June 2018
File name
Trevicta-C04-SPC-31May2018-Clean.docx
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4. – addition of sodium content statement
Section 4.8 – addition of ADRs: somnambulism (frequency rare) and sleep related eating disorder (frequency not known)
Updated on 27 June 2018
File name
Trevicta-PIL-C03-31May18-Clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 12 October 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 October 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Changes to Section 4.8 to align with Xeplion SmPC
Updated on 11 October 2017
File name
PIL_16760_601.pdf
Reasons for updating
- New PIL for new product
Updated on 11 October 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 22 September 2016
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 08 June 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 08 June 2016
Reasons for updating
- New PIL for new product