Elvinette 0.02mg/3mg film-coated tablets * Pharmacy Only: Prescription
Company:
Consilient Health LtdStatus:
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 02 November 2022
File name
63625eb5ecfb3.pdf
Reasons for updating
- Change to warnings or special precautions for use
Updated on 02 November 2022
File name
63625d32957e0.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
File name
CHC prescriber-checklist - IE Gedeon Richter FINAL_1620135061.pdf
Reasons for updating
- Add New Doc
File name
Information sheet for women - IE Gedeon Richter FINAL_1620135061.pdf
Reasons for updating
- Add New Doc
Updated on 15 July 2019
File name
01_P0904_345x635-approved 12.06.19_1563100136.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - overdose, missed or forgotten doses
Updated on 14 July 2019
File name
Elvinette 0.02mg-3mg fctbl_SmPC-approved 12.06.19_1563100067.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to include warning of depression and depressed moods when using hormonal contraception. Also warning of withdrawal bleeding following overdose.
Updated on 18 December 2018
File name
P0800 345x635 (16-7-18) - - Approved 13.12.18_1545135147.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 16 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 November 2017
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 15 November 2017
File name
PIL_16547_987.pdf
Reasons for updating
- New PIL for new product
Updated on 15 November 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 07 November 2016
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 03 November 2016
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 11 May 2016
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 25 April 2016
Reasons for updating
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 08 December 2015
Reasons for updating
- New PIL for medicines.ie
- PIL Submitted in error
Updated on 06 July 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)