Spravato 28 mg nasal spray, solution
*Company:
Janssen Sciences IrelandStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 09 January 2024
File name
EN-Spravato-PIL-clean-approved_19Oct23_44.0.pdf
Reasons for updating
- Change of distributor details
Free text change information supplied by the pharmaceutical company
Updated contact telephone number, and addition of email address, to local representative details in Section 6.
Updated on 31 October 2023
File name
EN-Spravato-20231019-SmPC.pdf
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
Additional clinical data
Updated on 24 July 2023
File name
Spravato SPC IE_July 2023.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
Shelf life has been updated from 3 to 4 years.
File name
Spravato HCP Guide_01.06.2023.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
The adverse events section has been updated to add respiratory depression as a rare adverse event. The ‘Disturbances in consciousness (sedation)’ section has been updated as follows: ‘In clinical trials, all cases of sedation resolved spontaneously; no respiratory depression was observed, and haemodynamic parameters remained within the normal range. During post-marketing use, rare cases of respiratory depression have been observed.’
File name
SPRAVATO_Patient Guide_01.06.2023.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Disturbances in consciousness (sedation) section of the Patient Guide has been updated as follows:
In clinical trials, all All the people who experienced sedation were able to breathe normally, had normal vital signs, and most recovered on the same day.1,3 During post-marketing use, rare cases of difficulty in breathing have been observed.
Updated on 15 December 2022
File name
EN-Spravato-PIL-Clean-approved_09Dec22_40.0.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Section 4 - updated respiratory side effect
Updated on 15 December 2022
File name
EN-Spravato-SmPC-clean-approved_09Dec2022 v40.0.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EUPI update: warnings & precautions section 4.4, isolated cases of respiratory depression observed with post marketing use implementing identical wording in CCDS v8 (adverse reactions section).
During the EMA PSUR procedure, EMA PRAC requested some rewording to the SmPC section 4.4 warning; addition of respiratory depression as an ADR at section 4.8 and addition of respiratory depression to the description of adverse events (SmPC section 4.8).
SmPC: Section 4.4 and 4.8
Patient Leaflet: Section 4
File name
Risk Minimisation Measures (RMM) _Spravato HCP Checklist_IE_clean version.pdf
Reasons for updating
- Replace File
Updated on 07 September 2022
File name
EN-Spravato-PIL-clean-approved_23Aug22_38.0.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 07 September 2022
File name
EN-Spravato-SmPC-clean-approved_23Aug2022 v38.0.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
RMM Spravato HCP Checklist_HPRA approved_EM55346.pdf
Reasons for updating
- Add New Doc
File name
Spravato RMM_Guide for HCP_HPRA_20211011.pdf
Reasons for updating
- Add New Doc
File name
RMM Spravato Patient Guide_20210715HPRA.pdf
Reasons for updating
- Add New Doc
Updated on 11 August 2021
File name
PIL-EN-Spravato-20210504-EUPI-IB-009-Clean-approved.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Changes to the PIL for updating:
- how to report a side effect
- marketing authorisation holder
- date of revision of the text
Updated on 10 August 2021
File name
SPC-EN-Spravato-20210504-EUPI-IB-009-CLEAN-approved.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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
Administrative changes only
Addition of 'Table 3' in section 4.8
Definition of MINI in section 5.1
Updated on 22 March 2021
File name
IE-Spravato-SPC-CLEAN.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 March 2021
File name
IE- Spravato-Package leaflet-CLEAN.pdf
Reasons for updating
- New PIL for new product