Apidra 100 units/ml solution for injection in a cartridge *

  • Company:

    SANOFI
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • 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 07 September 2020

File name

1.3.2 Mock-up PIL-Cartridge-786608-Ireland PRAC cutaneous amyloidosis (1) (1)_1599468575.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 03 September 2020

File name

1.3.1 SPC APIDRA Ireland PRAC cutaneous amyloidosis (1)_1599140396.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 September 2020

File name

1.3.2 Mock-up PIL-Cartridge-786608-Ireland PRAC cutaneous amyloidosis (1)_1599140336.pdf

Reasons for updating

  • Removal of one or more presentations from joint PIL

Updated on 11 September 2019

File name

Apidra1.3.2 Mock-up PIL-Cartridge-544253-Ireland CP split -SA1019-21_1568186244.pdf

Reasons for updating

  • Joint PIL superseded by individual PILs

Free text change information supplied by the pharmaceutical company

Replace UK/Ireland PIL with Ireland only PIL

Updated on 01 April 2019

File name

PIL Mock up Apidra Cartridge-544546 Remove OptiPen SA914-16_1553868974.pdf

Reasons for updating

  • 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 2 - pregnancy, breast feeding and fertility

Updated on 29 March 2019

File name

SPC APIDRA Ireland Remove OptiPen SA914-16_1553869152.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 4.6 - Pregnancy and lactation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 24 October 2018

File name

Apidra for injection in a cartridge PIL.pdf

Reasons for updating

  • XPIL Created

Updated on 29 May 2018

File name

Apidra for injection in a cartridge PIL.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 May 2018

File name

SPC Apidra vial cartridge and pre-filled pen IE.docx

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)