Reagila 4.5 mg hard capsules
*Company:
Recordati Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 19 April 2024
File name
ie-reagila-spc-Feb2022.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 February 2023
File name
ie-spc-reagila-february2022.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 April 2022
File name
Reagila SmPC.pdf
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 April 2022
File name
pil_REAGILA_caps_UK-IE.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
Removal of black triangle for intensive monitoring, update to contraceptive advice, minor update to side effects
Updated on 07 January 2022
File name
reaglia - IE SmPC.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
additional pack size for 4.5 mg and 6 mg capsules
Updated on 07 January 2022
File name
pil_REAGILA_caps_UK-IE_K27681-15_29431320-cropped.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Free text change information supplied by the pharmaceutical company
add pack size for 4.5 mg and 6 mg capsules
Updated on 21 October 2020
File name
reagila-PIL.pdf
Reasons for updating
- Removal/change of distributor
Updated on 27 June 2019
File name
reagila-PIL.pdf
Reasons for updating
- New PIL for new product
Updated on 27 June 2019
File name
reagila-SmPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)