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Saizen 8 mg/ml solution for injection

  • Name:

    Saizen 8 mg/ml solution for injection

  • Company:
    info
  • Active Ingredients:

    Somatropin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/08/19

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Summary of Product Characteristics last updated on medicines.ie: 21/8/2019

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Merck

Merck

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Medicine Name GONAL-f 1050 IU (77 micrograms) Active Ingredients Follitropin alpha
Medicine Name GONAL-f 300IU (22 mcg) pen Active Ingredients Follitropin alpha
Medicine Name GONAL-f 450 IU (33 mcg) pen Active Ingredients Follitropin alpha
Medicine Name GONAL-f 450 IU (33 micrograms) Active Ingredients Follitropin alpha
Medicine Name GONAL-f 75 IU (5.5 micrograms) Active Ingredients Follitropin alpha
Medicine Name GONAL-f 900 IU (66 mcg) pen Active Ingredients Follitropin alpha
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Medicine Name Praxilene Active Ingredients Naftidrofuryl Hydrogen Oxalate
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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 27 August 2019 PIL

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 SPC

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 1 November 2018 PIL

Reasons for updating

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

Updated on 1 November 2018 SPC

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 1 August 2018 SPC

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 PIL

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 SPC

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 2 May 2018 SPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 November 2017 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 14 September 2017 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 23 May 2017 PIL

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 PIL

Reasons for updating

  • Change to side-effects

Updated on 27 April 2015 PIL

Reasons for updating

  • Change to storage instructions

Updated on 14 April 2015 PIL

Reasons for updating

  • Change to storage instructions

Updated on 18 March 2014 PIL

Reasons for updating

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

Updated on 18 April 2013 PIL

Reasons for updating

  • Change to date of revision

Updated on 18 July 2012 PIL

Reasons for updating

  • Change of contraindications

Updated on 17 April 2012 PIL

Reasons for updating

  • New PIL for medicines.ie