Strensiq 100mg/ml
- Name:
Strensiq 100mg/ml
- Company:
Alexion Pharma UK Ltd
- Active Ingredients:
- Legal Category:
Product subject to restricted prescription (C)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/05/20
(Click to Download)XPIL
What Strensiq is and what it is used for
What Strensiq is and what it is used for
What you need to know before you use Strensiq
What you need to know before you use Strensiq
How to use Strensiq
How to use Strensiq
Possible side effects
Possible side effects
How to store Strensiq
How to store Strensiq
Contents of the pack and other information
Contents of the pack and other information
Click on this link to Download PDF directly
Alexion Pharma UK Ltd
Company Products
| Medicine Name | Active 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 1100mg/11ml | Active Ingredients Ravulizumab |
| Medicine Name Ultomiris 300mg/30ml | Active Ingredients Ravulizumab |
| Medicine Name Ultomiris 300mg/3ml | Active Ingredients Ravulizumab |
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 30 November 2020 SPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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
Update to section 5.1 - Removal of PIP compliance statement:
Paediatric population
The European Medicines Agency has deferred the obligation to submit the results of studies with Strensiq in one or more subsets of the paediatric population in hypophosphatasia (see section 4.2 for information on paediatric use).
Updated on 10 September 2020 SPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Shelf life extension variation. Update to ADR reporting details (addition of UK ADR reporting details inadvertently removed in previously uploaded version)
Updated on 3 September 2020 SPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.3 - Shelf life
- 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
Update to SmPC due to shelf life extension to 30 months - approved by EMA 01 Sept 2020.
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 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 4.8 - 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 SPC
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 SPC
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 SPC
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 SPC
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 SPC
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 SPC
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 SPC
Reasons for updating
- New SPC 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