Dectova 10 mg/mL solution for infusion
*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 29 August 2024
File name
ie-pl-combined-dectova-issue10draft1-emc.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
Section 4 - How to report a side effect updated to remove Northern Ireland details.
Updated on 19 January 2024
File name
ie-spc-dectova-issue5draft1-clean.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- 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)
Free text change information supplied by the pharmaceutical company
In Section 3 - Remove solution for infusion in the description.
In Section 4.2 - Move Pediatric population information into a new paragraph.
In Section 4.5 - Remove information on interaction with oral oseltamivir in a clinical study.
In Section 4.7 and 4.8 - Replace Dectova with Zanamivir.
In Section 5.2 - Move the Drug Interactions to Distribution and Biotransformation paragraphs.
In Section 9 - Update the renewal date.
Updated on 18 January 2024
File name
ieukni-pl-combined-dectova-issue9draft1-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 05 October 2021
File name
ieukni-pl-dectova-issue8draft1.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.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 22 January 2021
File name
ie-pl-dectova-issue6draft1_medicines.ie.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.pdf
Reasons for updating
- Change to MA holder contact details
Updated on 25 November 2020
File name
ie-pl-dectova-issue5draft1.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.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.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.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
GlaxoSmithKline (Ireland) Ltd
Address:
12 Riverwalk, Citywest Business Campus, Dublin 24, IrelandTelephone:
+353 1 495 5000Medical Information Direct Line:
1 800 244 255