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Saizen 8 mg/ml solution for injection

*
Pharmacy Only: Prescription

  • Company:

    Merck

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Somatropin

    *Additional information is available within the SPC or upon request to the company

Updated on 11 January 2024

File name

IE PIL Saizen 8mgml - QRD- TW4234358.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - duration of treatment
  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

QRD changes (minor editorial & grammatical changes). TW4234358

Updated on 11 January 2024

File name

IE SPC Saizen 8mg-QRD- TW4234358.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 4.6 - Pregnancy and lactation
  • 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

QRD changes (addition of traceability statement and minor editorial changes). TW4234358

Updated on 16 June 2023

File name

Saizen 8mg SPC - shelflife - June 2023 - TW3952201 v15.pdf

Reasons for updating

  • 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

To extend the shelf-life from 18 months to 2years – see SPC section 6.3 

Our reference: TW 3952201

Updated on 21 January 2022

File name

IE PIL Saizen 8 mgml - IA coolclick deletion - TW3167578 - Jan 2022 - CLEAN.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Removal of the cool click wording

Our Reference: TW3167578
 

Updated on 21 January 2022

File name

Saizen Solution 5.83mg and 8mg IE TW3167578 combined current v14.0.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Removal of the cool click wording

Our Reference: TW3167578
 

Updated on 27 August 2019

File name

MC-5874-2019 (12-20 PIL).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 21 August 2019

File name

Saizen Solution 5.83mg and 8mg IE TW1997614 combined current v13.0.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container
  • 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 01 November 2018

File name

8 pil (IE-MA Transfer).pdf

Reasons for updating

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

Updated on 01 November 2018

File name

Saizen_Solution_5.83mg_and_8mg_IE_TW1735731_combined_current_v12.0.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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 01 August 2018

File name

Saizen_Solution_5.83mg_and_8mg_IE_TW1712520_combined_current_v11.0.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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 17 July 2018

File name

Saizen 8mg PIL - CCDS 4.0 TW1663989.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 6 - date of revision

Updated on 17 July 2018

File name

Saizen_Solution_5.83mg_and_8mg_IE_TW1663989_combined_current_v10.0.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 4.5 - 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)

Updated on 02 May 2018

File name

Saizen_Solution_5.83mg_and_8mg_IE_TW1468646_combined_current_v9.0.docx

Reasons for updating

  • New SPC for new product

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

Updated on 24 November 2017

File name

PIL_15345_81.pdf

Reasons for updating

  • New PIL for new product

Updated on 24 November 2017

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 14 September 2017

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 23 May 2017

Reasons for updating

  • 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 - what the product looks like and pack contents

Updated on 19 August 2016

Reasons for updating

  • Change to side-effects

Updated on 27 April 2015

Reasons for updating

  • Change to storage instructions

Updated on 14 April 2015

Reasons for updating

  • Change to storage instructions

Updated on 18 March 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 18 April 2013

Reasons for updating

  • Change to date of revision

Updated on 18 July 2012

Reasons for updating

  • Change of contraindications

Updated on 17 April 2012

Reasons for updating

  • New PIL for medicines.ie