Violite 100/20 micrograms 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 17 November 2020
File name
common-spc_1605631386.pdf
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update of the product information to harmonise the safety information with the brand leader
Updated on 17 November 2020
File name
P1156 (appr 12.11.2020)_1605631294.pdf
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 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Update of the product information to harmonise the safety information with the brand leader
Updated on 22 May 2020
File name
common-spc-v005_1590152362.pdf
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 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 May 2020
File name
common-mockup-pl - v005_1590152179.pdf
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 4 - possible side effects
Updated on 17 October 2019
File name
common-mockup - Mar 2019_1571330441.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Update of the product information in line with the reference product
Updated on 17 October 2019
File name
common-spc-clean-08.03_1571330365.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 of the product information in line with the reference product
Updated on 11 March 2019
File name
Violite common-mockup_1552307405.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 11 March 2019
File name
Violite-common-spc-clean-19.12.2018_1552307589.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 October 2016
File name
PIL_16939_837.pdf
Reasons for updating
- New PIL for new product
Updated on 03 October 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)