Omjjara 100/150/200 mg film-coated tablets
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
UpdatedLegal Category:
Product subject to restricted prescription (C)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 07 April 2025
File name
ie-spc-omjjara-issue2draft1.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 07 April 2025
File name
ie-pl-omjjara-issue2draft1.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - marketing authorisation holder
Updated on 19 August 2024
File name
ie-pl-omjjara-issue1draft2-clean med.ie.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Launch of Omjjara in Ireland, following EMA MA approval in January 2025.
Updated on 19 August 2024
File name
ie-spc-omjjara-issue1draft1-clean med.ie.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Launch of Omjjara in Ireland, following EMA MA approval in January 2025.
GlaxoSmithKline (Ireland) Ltd
Address:
12 Riverwalk, Citywest Business Campus, Dublin 24, IrelandTelephone:
+353 1 495 5000Medical Information Direct Line:
1 800 244 255