Ezetimibe/Simvastatin 10 mg/20 mg, 10 mg/40 mg, 10 mg/80 mgTablets *
Company:
Gerard LaboratoriesStatus:
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
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 31 May 2021
File name
Ezetimibe Simvastatin SPC v019_1622469033.pdf
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 May 2021
File name
Ezetimibe Simvastatin PIL v019_1622468986.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 28 January 2021
File name
ie-spc-de6713-v018 cleanv017-clean_1611837319.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 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 January 2021
File name
ie-pil-de6713-v018 cleanv017-clean_1611837264.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 15 January 2021
File name
ie-PIL-de6713-clean-v018_1610715786.pdf
Reasons for updating
- Change to product name
Free text change information supplied by the pharmaceutical company
Changes in the (invested) name of the medicinal product in CY
Updated on 26 May 2020
File name
ie-SPC-es0279-clean-v015_1590474610.pdf
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 May 2020
File name
ie-PIL-es0279-clean-v015_1590474579.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 03 December 2019
File name
ie-spc-es0279-clean-renewal_1575361358.pdf
Reasons for updating
- 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 be renewed (B)
Updated on 13 November 2019
File name
ie-spc-es0279-clean-v014 Jul19_1573659418.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 June 2019
File name
Ezetimibe Simvastatin Package leaflet_1560265740.pdf
Reasons for updating
- New PIL for new product
Updated on 11 June 2019
File name
Ezetimibe Simvastatin SPC_1560265767.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)