DOPTELET 20mg film coated tablets
*Company:
Swedish Orphan Biovitrum 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 11 March 2024
File name
Doptelet SPC IE NI (March 2024).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)
Updated on 16 February 2024
File name
Doptelet SPC IE NI (February 2024).pdf
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 February 2024
File name
Doptelet SPC IE NI (February 2024).pdf
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 February 2024
File name
Doptelet PIL IE NI (February 2024).pdf
Reasons for updating
- Removal of Black Inverted Triangle
Updated on 19 January 2023
File name
Doptelet SPC Apr2021 (Ireland and Northern Ireland).pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 July 2022
File name
Doptelet PL Jun2022 (Ireland and Northern Ireland).pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 09 April 2021
File name
Doptelet SPC Apr2021 (Ireland and Northern Ireland).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 April 2021
File name
Doptelet PIL Apr2021 (Ireland and Northern Ireland).pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 26 January 2021
File name
Doptelet SPC Jan2021.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 January 2021
File name
Doptelet PL Jan2021.pdf
Reasons for updating
- Change to Section 1 - what the product is
- 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 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
Updated on 14 October 2020
File name
Doptelet SmPC Oct2020.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 October 2020
File name
Doptelet PL Oct2020.pdf
Reasons for updating
- New PIL for new product