Strensiq 100mg/ml

  • Name:

    Strensiq 100mg/ml

  • Company:
    info
  • Active Ingredients:

    Asfotase alfa

  • Legal Category:

    Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/05/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 7/5/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Alexion Pharma UK Ltd

Alexion Pharma UK Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Kanuma Active Ingredients Sebelipase alfa
Medicine Name Soliris Active Ingredients Eculizumab
Medicine Name Strensiq 100mg/ml Active Ingredients Asfotase alfa
Medicine Name Strensiq 40mg/ml Active Ingredients Asfotase alfa
Medicine Name Ultomiris Active Ingredients Ravulizumab
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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 7 May 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • 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

Renewal and QRD updates

Updated on 7 May 2020 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • 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

Renewal and QRD update

Updated on 7 May 2020 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 4.9 - Overdose
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Renewal of MA

Updated on 21 January 2020 PIL

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

Type II variation -43-G - to bring it in line with CCDS 03

Updated on 21 January 2020 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose

Updated on 21 January 2020 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.3 - Shelf life

Legal category: Product subject to restricted prescription (C)

Updated on 2 September 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder

Free text change information supplied by the pharmaceutical company

On 25July2019 the CHMP adopted a positive Opinion to approve Strensiq variation II/35/G (implementation of CCDS Version 2.0 Repooling of data).     

Updated on 2 September 2019 SmPC

Reasons for updating

  • 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 7 - Marketing authorisation holder

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

On 25July2019 a positive CHMP Opinion was adopted for Strensiq variation II/35/G  (implementation of CCDS Version 2.0 Repooling of data).   

Updated on 19 February 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 19 February 2019 SmPC

Reasons for updating

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

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Following the conclusion of regulatory procedure EMEA/H/C/PSUSA/00010421/201807 the product information documents were revised.  In section 4.8 the paragraph on immunogenicity is revised.  

Updated on 19 February 2019 SmPC

Reasons for updating

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

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Following the conclusion of regulatory procedure EMEA/H/C/PSUSA/00010421/201807 the product information documents were revised.  In section 4.8 the paragraph on immunogenicity is revised.  

Updated on 19 November 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Corrected information on How To Report an Adverse Drug Reaction 

Updated on 19 November 2018 SmPC

Reasons for updating

  • 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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

In section 6.5 (nature and contents of container) a correction is made to include the 3 ml vial (as well as the 2 ml vial). 

In section 10 (date of revision of the text) the date is changed to align with the EPAR on the EMA web site where the relevant regulatory procedure is listed (variation II/0029) in the assessment history and the EPAR - Product Information is shown with its Last Updated calendar date. 

Updated on 27 July 2018 PIL

Reasons for updating

  • XPIL Created

Updated on 25 July 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 14 March 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 14 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 July 2017 PIL

Reasons for updating

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

Updated on 19 January 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 18 January 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 21 December 2015 PIL

Reasons for updating

  • Change of manufacturer

Updated on 15 September 2015 PIL

Reasons for updating

  • New PIL for new product