Dectova 10 mg/mL solution for infusion * Pharmacy Only: Prescription
Company:
GlaxoSmithKline (Ireland) LtdStatus:
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 05 October 2021
File name
ieukni-pl-dectova-issue8draft1_1633446364.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
- PIL section 6 updated (local representative detials)
- Date of revision updated
Updated on 19 March 2021
File name
ie-pl-dectova-issue7draft1-medicines.ie_1616158904.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 22 January 2021
File name
ie-pl-dectova-issue6draft1_medicines.ie_1611331712.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 22 January 2021
File name
uk-pl-dectova-issue6draft1_medicines.ie_1611309160.pdf
Reasons for updating
- Change to MA holder contact details
Updated on 25 November 2020
File name
ie-pl-dectova-issue5draft1_1606297867.pdf
Reasons for updating
- New individual PIL (was previously included in a combined PIL)
Free text change information supplied by the pharmaceutical company
This PIL was split from a UK/IE joint PIL. The UK reporting details were removed. All other information remains the same.
Updated on 25 November 2020
File name
ie-spc-dectova-issue4draft1_1606297168.pdf
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
This SmPC was split from a UK/IE joint SmPC. The UK reporting details were removed. All other information remains the same.
Updated on 20 November 2019
File name
ukie-pl-dectova-issue4draft2_1574264728.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
This is a new Licnece approved by the EMA on the 26/04/2019.
Updated on 20 November 2019
File name
ukie-spc-dectova-issue3draft1_1574264642.pdf
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
This is a new licence approved by the EMA on the 26/04/2019