Apidra 100 units/ml solution for injection in a cartridge *
Pharmacy Only: Prescription

  • 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

Updated on 17 December 2021

File name

1.3.2 Mock-up PIL-Cartridge-Ireland_1639734717.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

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  • Joint PIL superseded by individual PILs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)