Apidra SoloStar 100 units/ml solution for injection in a pre-filled pen
*Company:
SANOFIStatus:
No Recent UpdateLegal 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 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- Joint PIL superseded by individual PILs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)