Prevenar 13 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):
*Additional information is available within the SPC or upon request to the company
Updated on 25 March 2024
File name
Adv PIL PN 24_0 IE NI clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 14 February 2023
File name
DEC202079950_Adv SPC PN 25_0 IE clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 November 2021
File name
Adv PIL PN 23_0 IE NI clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
- Individual PILs superseded by joint PIL
Updated on 01 December 2020
File name
DEC202079950_Adv SPC PN 25_0 IE clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Updated inline with QRD template and/or excipient guideline
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: Update of section 4.8 to add the adverse reaction anaphylaxis with a frequency not known to the group of children above 5 years of age and adults. The MAH has taken the opportunity to move all events reported in the post marketing setting (not only anaphylaxis) from an age specific subsection (6 weeks to 5 years) into a subsection addressing all age ranges. Minor updates in line with QRD 10.1 template. |
Updated on 01 December 2020
File name
DEC202079950_Adv PIL PN 22_0 IE clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 31 January 2020
File name
DEC202004396_Adv PIL PN 20_0 UK+IE clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 16 December 2019
File name
DEC201969853_Adv SPC PN 24_0 IE_clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic 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:
Update of section 5.1 with data on effectiveness in adults 65 years and older following the CAPiTA Public Health analysis.
Updated on 25 July 2019
File name
Adv PiL PN 19_1 UK+IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 25 July 2019
File name
Adv SPC PN 23_1 IE clean.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Please be advised that above country regulatory have agreed a new revision date for the Prevenar SPC and leaflet associated with this pack size variation change with EMA due to it being resubmitted for other presentations. The approval of the Type IA in variation is now the revision date for both the section 10 of the EU SmPC and corresponding section of the leaflet.
Updated on 30 April 2019
File name
DEC201922171_Adv PiL PN 19_0 UK+IE_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 30 April 2019
File name
DEC201922171_Adv SPC PN 23_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 02 October 2018
File name
Adv PiL PN 17_0 UK+IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 02 October 2018
File name
Adv SPC PN 22_0 IE clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
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The SPC has been updated as follows|;
SECTION 7 – Change to MAH
SECTION 10 – Date of revision of text
Updated on 23 April 2018
File name
Adv_PiL_PN_17_0_UK+IE_date_correction_CLEAN.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 09 March 2018
File name
PIL_14821_196.pdf
Reasons for updating
- New PIL for new product
Updated on 09 March 2018
Reasons for updating
- Change to section 6 - date of revision
- Change to section 6 - manufacturer
Updated on 12 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 January 2018
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
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Updated on 11 January 2018
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 27 March 2017
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)
Free text change information supplied by the pharmaceutical company
|
SPC |
UK brand marketing Please implement in line with REG08-WI-GBR04 SPC release and withdrawal |
Updated on 19 December 2016
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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Addition of text in section 4.5 of the SPC ‘Interaction with other medicinal products and other forms of interaction’
4.5 Interaction with other medicinal products and other forms of interaction
Updated on 14 December 2016
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)
Free text change information supplied by the pharmaceutical company
4.5 Interaction with other medicinal products and other forms of interaction
Updated on 22 November 2016
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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Addition of text in section 4.5 of the SPC ‘Interaction with other medicinal products and other forms of interaction’
4.5 Interaction with other medicinal products and other forms of interaction
Infants and children aged 6 weeks to 5 years
Prevenar 13 can be given concomitantly with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, acellular or whole cell pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B (see section 4.4 for guidance on Infanrix hexa), meningococcal serogroup C, measles, mumps, rubella, varicella and rotavirus vaccine.
Prevenar 13 can also be given concomitantly between 12-23 months with the tetanus toxoid conjugated meningococcal polysaccharide serogroups A, C, W and Y vaccine to children who have been adequately primed with Prevenar 13 (as per local recommendations).
Updated on 22 August 2016
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 19 August 2016
Reasons for updating
- Change to date of revision
Updated on 12 July 2016
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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Addition of text in section 4.5 of the SPC ‘Interaction with other medicinal products and other forms of interaction’
Adults aged 50 years and older
(…)
In a third study in adults aged 50-93 years, it was demonstrated that Prevenar 13 may be given concomitantly with the seasonal quadrivalent inactivated influenza vaccine (QIV). The immune responses to all four QIV strains were noninferior when Prevenar 13 was given concomitantly with QIV compared to when QIV was given alone.
The immune responses to Prevenar 13 were noninferior when Prevenar 13 was given concomitantly with QIV compared to when Prevenar 13 was given alone. As with concomitant administration with trivalent vaccines, immune responses to some pneumococcal serotypes were lower when both vaccines were given concomitantly.
Updated on 11 July 2016
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 03 May 2016
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
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: Update to section 6.6 of the SPC, addition of text in blue below:
‘During storage, a white deposit and clear supernatant can be observed. This does not constitute a sign of deterioration.’Updated on 29 April 2016
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 09 December 2015
Reasons for updating
- Change to information about driving or using machinery
- Change to MA holder contact details
- Addition of information on reporting a side effect.
Updated on 19 November 2015
Reasons for updating
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 5.1 - Pharmacodynamic 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:
Section 4.7 – Addition of text relating to ‘Driving and using machinery’
Section 5.1 – Addition of effectiveness dataUpdated on 17 November 2015
Reasons for updating
- Change to information about driving or using machinery
- Change to date of revision
Updated on 22 October 2015
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)
Free text change information supplied by the pharmaceutical company
Updated on 05 May 2015
Reasons for updating
- Improved electronic presentation
Updated on 09 March 2015
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
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
Section 4.1 – Therapeutic Indications - To extend the indication to include pneumonia for adults aged 18 years and over
Section 4.8 - Sub heading- Adults ≥18 years and the elderly – Update to data on clinical studies
Section 5.1 - Sub heading- Adults ≥18 years and the elderly – Update to data on CAP and IPD
Section 5.1 – removal of the following statement from the EU SmPC
“The European Medicines Agency has deferred the obligation to submit the results of studies with Prevenar 13 in one or more subsets of the paediatric population in pneumococcal disease (See section 4.2 for information on paediatric use)”
- This statement is an obligatory statement in the SmPC for all products with a PIP which has deferred studies. This was the first opportunity to remove the statement following completion of our PIP in 2014.
Section 5.1 – Addition of sub-heading – “Efficacy study in adults 65 years and older”- information added to the SPC relating to the CAPiTA study.
Section 9: Editorial update to text
Section 10: Date of revision of text update to 02/2015
Updated on 05 March 2015
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
Updated on 29 September 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4- Addition of wording on sodium
Section 4.8 – Update to reporting of side effects details from IMB to HPRA
Minor updates to section 5.2 and 5.3
Section 9 – Addition of date of last renewal date
Section 10 – Update to date of revision to 09/2014Updated on 22 September 2014
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 26 August 2014
Reasons for updating
- Improved electronic presentation
Updated on 06 July 2014
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 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updates to Sections: 4.2, 4.4, 4.8, 5.1 & 10
Updated on 02 July 2014
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 01 April 2014
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)
Free text change information supplied by the pharmaceutical company
Wording has been added:
‘Data from a postmarketing clinical study evaluating the impact of prophylactic use of antipyretics
(ibuprofen and paracetamol) on the immune response to Prevenar 13 suggest that administration of
paracetamol concomitantly or within the same day of vaccination may reduce the immune response to
Prevenar 13 after the infant series. Responses to the booster dose administered at 12 months were
unaffected. The clinical significance of this observation is unknown.’
Updated on 06 December 2013
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 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.5
Section 4.8
Updated on 28 November 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 28 October 2013
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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2
Section 4.4
Section 4.8
Section 5.1
Updated on 22 October 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
Updated on 16 July 2013
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
To expand the indication to include adults aged 18-49 years.
The following sections of the SPC have been updated:
4.1 Therapeutic indication
4.2 Posology and method of administration
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.8 Undesirable effects
5.1 Pharmacodynamic properties
10 – Date of revision of text.
Updated on 12 July 2013
Reasons for updating
- Change to, or new use for medicine
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
- Addition of marketing authorisation holder
Updated on 17 January 2013
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 17 years of age.
Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults aged 50 years and older.
Updated on 11 January 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
- Changes to therapeutic indications
Updated on 17 December 2012
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
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 and 4.8 – information regarding Prevenar 13v and Infarix neurological events
Section 4.5- addition of Rotavirus vaccine
Section 4.6 – addition of headings and text in line with QRDv8 template
Section 5.1 – addition of information on Nasopharyngeal Carriage
Section 6.4 – addition of temporary temperature excursion text
Addition of headings and minor text updates to bring SPC in line with QRDv8
Updated on 28 November 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
- Improved electronic presentation
Updated on 18 July 2012
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 12 July 2012
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 02 April 2012
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 5.1 - Pharmacodynamic properties
Updated on 29 March 2012
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 09 November 2011
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
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
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Section 4.1 – Therapeutic indications
Section 4.2 – Posology and method of administration
Section 4.4 – Special warnings and precautions for use
Section 4.5 - Interaction with other medicinal products and other forms of interaction
Section 4.6 - Fertility, pregnancy and lactation
Section 4.8 - Undesirable effects
Section 5.1 - Pharmacodynamic properties
Section 5.3 - Preclinical safety data
Updated on 04 November 2011
Reasons for updating
- Change to side-effects
- Change to date of revision
- Changes to therapeutic indications
Updated on 14 December 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 5.1 the following paragraph has been added:
Immune responses after subcutaneous administration
Subcutaneous administration of Prevenar 13 was evaluated in a non-comparative study in 185 healthy Japanese infants and children who received 4 doses at 2, 4, 6 and 12-15 months of age. The study demonstrated that safety and immunogenicity were generally comparable with observations made in studies of intramuscular administration.
Section 4.4 the following paragraph has been amended:
This vaccine should not be given as an intramuscular injection to infants or children with thrombocytopaenia or any coagulation disorder that would contraindicate intramuscular injection, but may be given subcutaneously if the potential benefit clearly outweighs the risks (see section 5.1).
Updated on 13 October 2010
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 13 October 2010
Reasons for updating
- New PIL for new product