DOPTELET 20mg film coated tablets *
Pharmacy Only: Prescription

  • Company:

    Swedish Orphan Biovitrum Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

Updated on 01 July 2022

File name

62bebd2b74446.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 09 April 2021

File name

Doptelet SPC Apr2021 (Ireland and Northern Ireland)_1617970112.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)_1617970072.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 26 January 2021

File name

Doptelet SPC Jan2021_1611653048.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_1611652820.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_1602683725.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_1602683710.pdf

Reasons for updating

  • New PIL for new product