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Synarel Nasal Spray

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Pharmacy Only: Prescription
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Updated on 17 October 2024

File name

Reg PIL SL 17_0 IE clean.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

The PIL has been updated to reflect the SPC change for the MAH name and address

Updated on 17 October 2024

File name

Reg SPC SL 13_0 IE clean.pdf

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

The SPC has been updated as follows:

Section 7 Change of MAH name and address. 

Updated on 15 November 2022

File name

RegSPCSL120IEclean.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)

Updated on 15 November 2022

File name

RegPILSL160IEclean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 10 February 2022

File name

RegSPCSL110IEclean.pdf

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

The SPC has been updated as follows: Section 4.4 add a warning on ovarian hyperstimulation syndrome

Updated on 10 February 2022

File name

RegPILSL150IEclean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 17 July 2018

File name

Reg PIL SL 14_2 IE Clean.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 17 July 2018

File name

Reg SPC SL 9_3 IE Clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.2 and 6.6 of the Summary of Product Characteristics and Section 3 of the Patient Information Leaflet for Synarel (nafarelin acetate) to improve and harmonize the instructions given to patients concerning the importance of cleaning the tip of the pump before and after use and the potential impact of low or missed doses caused by the pump clogging..

Updated on 19 October 2017

File name

PIL_13507_361.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 October 2017

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - excipient warnings
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 12 February 2015

Reasons for updating

  • New SPC for new product

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

Updated on 12 February 2015

Reasons for updating

  • 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

Section 4.8 Undesirable Effects: Ovarian hyperstimulation syndrome has been added as an ADR of an unknown frequency.

Updated on 12 February 2015

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 18 June 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

Upddates to section 4.8 & 10

Updated on 11 June 2014

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

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 – Update to details for  reporting of side effects

Section 10 – Update to date of revision of the text

All sections – Formatting changes were made throughout the SPC

Updated on 10 June 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision

Updated on 11 January 2013

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

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

Free text change information supplied by the pharmaceutical company

Section 4.3 contraindications

Section 4.4 Special warnings and precautions for use

Section 4.5 Interactions with other medicinal products and other forms of interaction

Section 4.6 Fertility, pregnancy and lactation

Section 4.8 Undesirable effects

Updated on 11 January 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation

Updated on 31 May 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

section 7- updated with Pfizer Healthcare Ireland
section 8 - updated with new PA number

Updated on 30 May 2012

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 27 February 2012

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

SPC Update to sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8 and 5.3

Updated on 27 February 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Improved electronic presentation

Updated on 19 October 2011

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

SmPC change of the name of MA holder from Pharmacia Ireland Limited to Pharmacia Ireland, sections updated: 7 and  10.

Updated on 18 October 2011

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 15 June 2011

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability
  • Change due to user-testing of patient information

Updated on 13 August 2010

Reasons for updating

  • Correction of spelling/typing errors

Updated on 14 December 2009

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 01 July 2009

Reasons for updating

  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

In Section 6.1 - Slight change to list of excipients to include pH adjustors

Updated on 05 June 2009

Reasons for updating

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

Updated on 19 August 2008

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

Section 10 - Updated 'Date of revision of the text'

Updated on 18 August 2008

Reasons for updating

  • New PIL for medicines.ie

Updated on 09 August 2004

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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

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

Updated on 19 August 2003

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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)

Updated on 07 July 2003

Reasons for updating

  • New SPC for medicines.ie

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

Pfizer Healthcare Ireland Unlimited Company

Pfizer Healthcare Ireland Unlimited Company