Strensiq 100mg/ml * Pharmacy Only: Prescription
Company:
Alexion Pharma UK LtdStatus:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 24 June 2021
File name
ie-ni_strensiq_pil_100mg-ml_IB-054_18Jun2021_1624552690.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
PIL update due to correction of aquous solution description in alignment with approved drug product specification for 'Appearance' (section 3 and 6), updated wording on Strensiq administration instructions (section 3), alignment with the latest QRD (section 4), date of revision - June 2021 (section 6).
Updated on 24 June 2021
File name
ie-ni_strensiq_combined spc_IB-054_18Jun2021_1624550826.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
SmPC update due to correction of aquous solution description in alignment with approved drug product specification for 'Appearance' (section 3), minor editorial changes (section 5.1), update to the latest QRD in section 4.8 Reporting of suspected adverse reactions for the inclusion of UK (Northern Ireland), Section 10 Date of revision of the text – 18 June 2021.
Updated on 30 November 2020
File name
Strensiq_spc_24Nov2020_1606737085.pdf
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
File name
uk-ie-mt_Strensiq_spc_combined_clean_1599724776.pdf
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 03 September 2020
File name
Strensiq_spc_combined_ie-mt_1599131157.pdf
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 07 May 2020
File name
Strensiq_100_Leaflet_UK_IE_25July2019_1567433298.pdf
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 07 May 2020
File name
Strensiq_100_Leaflet_UK_IE_25July2019_1567433298.pdf
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 07 May 2020
File name
Clean SmPC_1588859835.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 4.8 - 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
File name
Strensiq_100_Leaflet_UK_IE_25July2019_1567433298.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
Type II variation -43-G - to bring it in line with CCDS 03
Updated on 21 January 2020
File name
Strensiq_100_Leaflet_UK_IE_25July2019_1567433298.pdf
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
File name
Strensiq_SmPC_UK_IE-12December2019_1579623215.pdf
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 02 September 2019
File name
Strensiq_100_Leaflet_UK_IE_25July2019_1567433298.pdf
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 02 September 2019
File name
Strensiq_SmPC_UK_IE_25July2019_1567430304.pdf
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
File name
Strensiq_PL_100_1February2019_1550572102.pdf
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
File name
Strensiq_SmPC_1February2019_1550570224.pdf
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
File name
Strensiq_PL_100_1February2019_1550569989.pdf
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
File name
Strensiq_SmPC_19November2018_clean_1542636414.pdf
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
File name
Strensiq_SmPC_19November2018_clean_1542630995.pdf
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
File name
PIL_16482_716.pdf
Reasons for updating
- XPIL Created
Updated on 25 July 2018
File name
Strensiq_SmPC_14March2018.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Updated on 14 March 2018
File name
PIL_16482_716.pdf
Reasons for updating
- New PIL for new product
Updated on 14 March 2018
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 17 July 2017
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
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
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
Reasons for updating
- Change of manufacturer
Updated on 15 September 2015
Reasons for updating
- New PIL for new product