Dectova 10 mg/mL solution for infusion *
Pharmacy Only: Prescription

  • Company:

    GlaxoSmithKline (Ireland) Ltd
  • Status:

    No Recent Update
  • Legal 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