Nimenrix powder and solvent for solution for injection in pre-filled syringe

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/04/19

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Summary of Product Characteristics last updated on medicines.ie: 1/4/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
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Medicine Name Atorvastatin Pfizer 10 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atorvastatin Pfizer 20 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atorvastatin Pfizer 40 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atorvastatin Pfizer 80 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
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1 - 0 of 231 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 1 April 2019 PIL

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - date of revision

Updated on 1 April 2019 SmPC

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 - 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 25 January 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 25 January 2019 SmPC

Reasons for updating

  • 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

Update of section 4.4 of the SmPC in order to add a warning about an increased risk of invasive disease caused by Neisseria meningitidis group A, C, W-135 and Y”.

Updated on 23 October 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 19 October 2018 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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 6.3 is updated with the new shelf-life.

Updated on 8 August 2018 PIL

Reasons for updating

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

Updated on 8 August 2018 SmPC

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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows|;
SECTION 7 – Change to MAH

SECTION 10 – Date of revision of text

Updated on 13 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 13 May 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 4 May 2018 SmPC

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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:  Section 4.5 and 4.8 update with new adolescent co-administration data (Boostrix and Cervarix).

Updated on 26 April 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 21 March 2018 SmPC

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

The SPC has been updated as follows: Section 4.4 updated to delete text regarding immunogenicity in vulnerable populations. Additional information added to the end of section 5.1 regarding responses in patients with anatomic or functional asplenia.

Updated on 21 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 9 March 2017 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Removal of black triangle

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:

Black triangle is removed.

Section 10 – Date of revision is  updated.

Updated on 3 March 2017 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Removal of black triangle

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:

Black triangle is removed.

Section 10 – Date of revision is  updated.

Updated on 28 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 February 2017 PIL

Reasons for updating

  • Removal of black triangle

Updated on 21 December 2016 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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
  • 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



The SPC has been updated as follows:

Update to section 4.1 and consequential changes to other SPC sections as follows:

4.1     Therapeutic indications

 

Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135, and Y.

 

Section 4.2 is updated to include posology for infants

Section 4,5 is updated with information on concomitant medication for infants

Section 4.8 safety profile summary is updated with information on safety in infants

Section5.1 is updated with information on immunogenicity in infants, tables and other sections have been updated accordingly.

Section 10 – Date of revision is  updated.

Updated on 19 December 2016 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 14 October 2016 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.5 and 5.1 – please refer to track changes SPC for further details on changes/additions to the text.

Section 10 – Date of revision updated.

Updated on 13 October 2016 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 1 September 2016 SmPC

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

The SPC has been updated as follows:

Updates to sections 4.2, 4.4, 4.8, 5.1 – please refer to track changes SPC for further details on changes/additions to the text.

Section 10 – Date of revision updated.

Updated on 26 August 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 8 August 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 8 August 2016 SmPC

Reasons for updating

  • 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

Update to SmPC section 5.1 is updated to reflect the currently observed data re the immune response following one or two doses of Nimenrix given 2 months apart was evaluated one month after the last vaccination. 

Section 4.4 is updated to consider providing a second dose of Nimenrix to toddlers who are expected to have a particular risk of exposure to serogroups W-135 and Y.

Section 4.8 has been updated to reflect the safety data available from the study that a second dose of Nimenrix in toddlers, with a dose interval of 2 months, has a similar reactogenicity profile compared to the 1st dose.

Updated on 12 May 2016 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 12 May 2016 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Change to Section 7 - transfer from GSK to Pfizer Ltd

Updated on 9 April 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation

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: Deletion of text

Section 4.8 Update to summary of safety profile (Update of the number of subjects included in the pooled analysis on which the safety profile is based on).

Section 5.1 - Correction of data from studies MenACWY-TT-036, -038 and -043

Updated on 19 September 2014 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • 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 5.1
Persistence of immune response – correction to the clinical data for evaluation in subjects 12 months to 55 years

Persistence of immune response in toddlers – correction to typo error ‘age’

Section 6.3
After reconstitution – correction to stability after reconstitution should be 8 hours not 48 hours.

Updated on 1 September 2014 SmPC

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • 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 5.2 – correction to footer in table 9

Section 6.3 –clarity given on reconstitution of vaccine

 

Updated on 29 August 2014 PIL

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 11 August 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 11 August 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.8 addition of Extensive Limb swelling as Rare frequency
Section 4.8 change to name of Ireland Competent Authority from IMB to HPRA.

Updated on 2 July 2014 PIL

Reasons for updating

  • Addition of marketing authorisation holder

Updated on 6 June 2014 SmPC

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 - how to report a side effect
  • 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

Sections 4.2 - Editorial changes.
Section 4.4 - Updated the warning regarding persistence of serum bactericidal antibody titres.
Section 4.8 - Updated the IMB contact details for the reporting of adverse events.
Section 5.1 - Updated the clinical data regarding persistence of immune response.
Section 10 - Updated date of revision of text.

Updated on 11 February 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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)

Free text change information supplied by the pharmaceutical company

Changes to:

Section 4.2 - Posology and method of administration,
Section 4.8 - Undesirable effects,
Section 5.1 - Pharmacodynamic properties

Updated on 10 February 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 13 August 2012 SmPC

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

None provided

Updated on 31 July 2012 PIL

Reasons for updating

  • New PIL for new product