Somavert 10mg, 15mg, 20mg, 25mg and 30mg Powder and Solvent for Solution for Injection
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 23 November 2023
File name
Adv PIL SV 21_0 IE NIclean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 20 June 2022
File name
ADV SPC SV 23_0 IE clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 September 2021
File name
DEC202162905_Adv PIL SV 20_0 IE NI clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
Updated on 24 February 2021
File name
DEC202112602_ADV SPC SV 22_0 IE clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 February 2021
File name
DEC202112602_Adv PIL SV 19_0 IE clean.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 09 December 2020
File name
DEC202080273_ADV SPC SV 21_0 IE clean.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 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 December 2020
File name
DEC202080273_Adv PIL SV 18_0 IE clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 09 December 2020
File name
DEC202082509_Adv PIL bZR 6_0 UK - clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 08 October 2020
File name
DEC202067252_ADV SPC SV 20_0 IE clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 October 2020
File name
DEC202067252_Adv PIL SV 17_0 IE clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 20 August 2020
File name
DEC202055255_ADV SPC SV 19_0 IE clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 August 2020
File name
DEC202055255_Adv PIL SV 16_0 IE clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 19 November 2019
File name
Adv PIL SV 15_0 UK_IE.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 08 March 2019
File name
DEC201911276_ADV SPC SV 18_0 UK_IE clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
|
The SPC has been updated as follows: Section 4.4 of the SmPC to enable differentiation between two situations of elevated liver enzymes that may arise for a patient and Update to section 10 of the SmPC to align with the QRD template (v.10). |
Updated on 23 October 2018
File name
Adv PIL SV 13_0 UK_IE.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 18 October 2018
File name
ADV SPC SV 17_0 UK_IE.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC sections affected are Section 4.2 and 4.4 of SmPC updated to provide prior warning and detailed recommendations on the need for the physician to measure liver enzymes prior to initiation of treatment with SOMAVERT. Corresponding sections of PIL are also updated to align with changes to SmPC.
Updated on 29 August 2018
File name
Adv PIL SV 12_0 UK_IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 29 August 2018
File name
ADV SPC SV 16_0 UK_IE clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Section 7 Marketing Authorisation Holder has changed from Pfizer Ltd UK to Pfizer EEIG Belgium
Updated on 12 July 2018
File name
ADV_SPC_SV_15_0_UK_IE_clean.docx
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Section 6.4 is updated to include storage condition for prefilled syringe
Updated on 12 July 2018
File name
Adv PIL SV 11_0 UK_IE clean.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 12 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 January 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 January 2017
Reasons for updating
- 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
Updated on 13 January 2017
File name
PIL_8920_105.pdf
Reasons for updating
- New PIL for new product
Updated on 13 January 2017
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 04 November 2016
Reasons for updating
- 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
Updated on 03 November 2016
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 08 August 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updates to Section 2, 4.2 and 5.1: editorial changes
Section 6.5 and 6.6: Implementation of changes to EU PI to incorporate pre-filled syringe container closure system in place of glass vial for diluent used in preparation of dose.Updated on 05 August 2016
Reasons for updating
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
- Change to dosage and administration
Updated on 26 July 2016
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 4.2 - 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 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - MA number
- Change to section 9 - Date of renewal of authorisation
- 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
The changes to the SPC are as detailed below:
Section 1: editorial changes
Section 2- change of formatting from tabular format to free text
Section 3: addition of (powder for injection) as a shorter version of the pharmaceutical form
Section 4.2, 4.4, 4.6: editorial changes
Section 4.8: update ADR Frequencies and formatting from free text to tabular format
Section 6.5: updated description of pack sizes
Section 6.6: editorial change
Section8: editorial changes
Section 9- editorial changes
Section10: new revision date
Updated on 22 July 2016
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to date of revision
Updated on 23 July 2015
Reasons for updating
- Introduction of new strength
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
· The SPC has been updated as follows: Line extension 25mg and 30mg strengths and QRD
Updated on 21 July 2015
Reasons for updating
- Change to packaging
- Change to side-effects
- Change to further information section
- Change to date of revision
- Change to MA holder contact details
- Change to improve clarity and readability
- Change of special precautions for disposal
- Introduction of new pack/pack size
Updated on 25 June 2015
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 19 March 2014
Reasons for updating
- 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
Updated on 10 September 2013
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
- Addition of marketing authorisation holder
Updated on 04 January 2012
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 04 January 2012
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 16 June 2011
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 30 November 2010
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SmPC – The Black Triangle has been removed from Section 1 of the SmPC. Since we maintain a combined Somavert SmPC for UK and Ireland, the labelling for both markets is affected by this change.
Updated on 11 February 2010
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
5.3 Preclinical safety data (submission of a non-clinical carcinogenicity report and the related updates in section 5.3 of the SmPC)
Updated on 27 August 2009
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 17 June 2008
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 21 February 2008
Reasons for updating
- Correction of spelling/typing errors
Updated on 25 January 2008
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
- Change to dosage and administration
- Addition of joint PIL covering all presentations
Updated on 18 January 2008
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of authorisation
- 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
4.2 – Update to section
4.8 – Update to section and Addition of text
6.5 - Update to Section
9 - Update to Section
Updated on 12 October 2007
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to further information section
- Change to date of revision
Updated on 09 October 2007
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
2 – Update to Section 2
4.2 - addition of “There is no experience in children”
4.5: revision to interaction studies statement
4.5 – revision of wording under “Use in Lactation”
4.8 – Update Section 4.8 (Undesirable effects)
5.1 - Update to Section 5.1 (Pharmacotherapeutic group)
6.2 - Update to Section 6.2
6.4 – Update to Section 6.4
6.6 - Update to Section 6.4
Updated on 11 January 2006
Reasons for updating
- Change to packaging
Updated on 07 April 2005
Reasons for updating
- Change to further information section
Updated on 05 April 2005
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 September 2004
Reasons for updating
- New PIL for medicines.ie
Pfizer Healthcare Ireland Unlimited Company
Address:
The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, IrelandTelephone:
+353 1 467 6500Fax:
+353 1 467 6501Website:
https://www.pfizermedicalinformation.ie/Medical Information Direct Line:
1 800 633 363