Prevenar 20 (formerly Apexxnar) suspension for injection
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)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 25 April 2025
File name
Adv PIL PE 6_0 IE clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
- Change to MA holder contact details
Free text change information supplied by the pharmaceutical company
The PIL has been updated to reflect the SPC changes, to remove UK (NI) ADR reporting details, and with the IE LE update.
Updated on 25 April 2025
File name
Adv SPC PE 7_0 IE clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Sections 2 and 4.4 to include information for the polysorbate 80 excipient; update of the EMA website link.
Updated on 13 November 2024
File name
Adv SPC PE 6_0 IE clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Sections 5.1 and 5.2 to add conclusions from study 1027 and remove the information on paediatric deferral since all studies are now complete.
Updated on 13 March 2024
File name
Adv SPC PE 50 IE clean.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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 March 2024
File name
Adv PIL PE 50 IE NI clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- 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 - manufacturer
- Change to section 6 - date of revision
- Change to name of medicinal product
- Change to information for healthcare professionals
Updated on 12 January 2023
File name
Adv SPC PE 4_0 IE clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 January 2023
File name
Adv PIL PE 4_0 IE NI clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 10 November 2022
File name
Adv SPC PE 3_0 IE clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 November 2022
File name
Adv PIL PE 3_0 IE NI clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 09 September 2022
File name
Adv SPC PE 2_0 IE clean.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 September 2022
File name
Adv PIL PE 2_0 IE NI clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 11 April 2022
File name
Adv SPC PE 1_0 IE.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 April 2022
File name
Adv PIL PE 1_0 IE NI.pdf
Reasons for updating
- New PIL for new product
Pfizer Healthcare Ireland Unlimited Company
Address:
The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, IrelandTelephone:
+353 1 467 6500Fax:
+353 1 467 6501Website:
https://www.pfizermedicalinformation.ie/Medical Information Direct Line:
1 800 633 363