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
When a pharmaceutical company changes any document, 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 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