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  • Apidra SoloStar 100 units/ml solution for injection in a pre-filled pen

Apidra SoloStar 100 units/ml solution for injection in a pre-filled pen

*
Pharmacy Only: Prescription

  • Company:

    SANOFI

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Insulin Glulisine

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

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Updated on 01 April 2025

File name

1.3.1 SPC APIDRA Ireland PRAC cutaneous amyloidosis (7).pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Updated on 06 March 2025

File name

1.3.1 SPC APIDRA Ireland PRAC cutaneous amyloidosis.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Updated on 17 December 2021

File name

1.3.2 Mock-up PIL SoloStar IE.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 15 February 2021

File name

1.3.2 Mock-up PIL SoloStar IE Approved on 05 November 2020.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 19 October 2020

File name

1.3.2 Mock-up PIL SoloStar IE 786319 PRAC cutaneous amyloidosis.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 07 September 2020

File name

1.3.2 IE Mock-up PIL SoloStar 770114 Malta rep update SA1770.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).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 5.2 - Pharmacokinetic properties

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

Updated on 02 April 2020

File name

1.3.2 IE Mock-up PIL SoloStar 770114 Malta rep update SA1770.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 11 September 2019

File name

Apidra1.3.2 Mock-up PIL SoloStar 544168 Ireland CP split SA1019-21.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 SoloStar 544458 Remove OptiPen SA914-16.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.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

NEW PIL Apidra SoloStar.pdf

Reasons for updating

  • XPIL Updated

Updated on 16 October 2018

File name

NEW PIL Apidra SoloStar.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 29 May 2018

File name

Apidra SoloStar injection in a pre-filled pen 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)

SANOFI

66c71a9b07f94