INNOVACE TABLETS
*Company:
Organon Pharma (Ireland) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 28 March 2023
File name
Innovace-SE-H-0404-IA757G-PIL-IE-en-CRT.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Site Name change
Updated on 26 January 2023
File name
Innovace-SE-H-0404-001-004-MAT-SPC-IE-en-CRT.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 30 August 2021
File name
Innovace-SE-H-0404-001-004-MAT-SPC-IE-en-CRT.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Marketing Authorisation Transfer to Organon
Updated on 30 August 2021
File name
Innovace-SE-H-0404 MAT combined-PIL-IE-en-CRT.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change of licence holder
Updated on 04 August 2021
File name
Innovace-SE-H-0404-WS-054-PIL-IE-en-CRT.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 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 04 August 2021
File name
Innovace-SE-H-0404-001-004-WS-054-SPC-IE-en-CRT Jul 2021.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update PI regarding ACE inhibitors/Neprylisin inhibitors
Updated on 05 January 2021
File name
QRD-IE-INNOVACE-SE-H-0404-LFT-WS-422-Dec2020 (002).pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update to section 2.0 to describe the sodium content in this medicine.
Updated on 05 January 2021
File name
INNOVACE-SE-H-0404-001-004-IB-WS422-SPC-IE-en-Dec2020 (002).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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to section 4.4 to describe the sodium content in this medicine.
Updated on 04 December 2020
File name
QRD-IE-INNOVACE-2.5mg5mg10mg20mg-LFT-IA645G-Oct2020-CRT (002).pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Update to manufacturer details in section 6.0.
Updated on 27 November 2019
File name
INNOVACE-SE-H-0404-002-IA050-SPC-IE-en-CRT (002).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 medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Deletion of the 60 tablet pack size for Innovace 5 mg Tablets
Updated on 27 November 2019
File name
QRD-INNOVACE-IA050-PIL-IE-en-CRT (002).pdf
Reasons for updating
- Change to section 6 - date of revision
- Deletion of a pack size
Updated on 20 June 2019
File name
QRD INNOVACE-WS-083+086-PIL-IE-en-CRT.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to warnings or special precautions for use
- Change to drug interactions
Updated on 19 June 2019
File name
INNOVACE-SE-H-0404-001-004-WS-086-SPC-IE-en-CRT.pdf
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
New text regarding concomitant use of other drugs that may increase serum potassium levels (e.g. trimethoprim/sulfamethoxazole)
Updated on 28 March 2019
File name
QRD file - Innovace Leaflet -WS-083_CRT.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to warnings or special precautions for use
- Change of contraindications
- Change to drug interactions
Updated on 28 March 2019
File name
INNOVACE-SE-H-0404-001-004-II-WS-083-SPC-IE-en-CRT.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated regarding drug interaction between ACE-inhibitor and neprilysin (NEP) inhibitor resulting in an increased risk of angioedema
Updated on 29 August 2018
File name
INNOVACE-SE-H-0404-001-004-IAIN-046-SPC-IE-en-CRT Aug 2018 (2).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 medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to section 6.5 Nature and contents of container e.g. Innovace 5 mg tablet has a new pack size of 56 tablets
Updated on 15 August 2018
File name
QRD file - Innovace Leaflet - Deletion of UK details + IA046-CRT (2).pdf
Reasons for updating
- 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 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 15 March 2018
File name
PIL_9237_75.pdf
Reasons for updating
- New PIL for new product
Updated on 15 March 2018
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 13 May 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to drug interactions
- Change to date of revision
Updated on 10 May 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 May 2016
Reasons for updating
- 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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to Section 4.4 - Special warnings and precautions for use
Change to Section 4.5 - Interactions with other medicinal products and other forms of interaction
Change to Section 10 - Date of revision of the textReasons for submission: Type II036; Angiodema and ACE inhibitor and mTOR update
Updated on 10 February 2015
Reasons for updating
- Change to section 4.3 - Contraindications
- 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
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to Section 4.3 - Contraindications
Change to Section 4.4 - Special warnings and precautions for use
Change to Section 4.5 - Interactions 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 10 - Date of revision of the text
Updated on 09 February 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to date of revision
Updated on 26 June 2014
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 21 May 2014
Reasons for updating
- Change to MA holder contact details
Updated on 25 April 2014
Reasons for updating
- Change to section 8 - MA number
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Which SPC sections have changed: Sections 7 & 8 Change information: Change to the MAH name and address and new PA numbers.
Updated on 13 March 2014
Reasons for updating
- Change of contraindications
- Change to information about pregnancy or lactation
Updated on 29 January 2014
Reasons for updating
- Change to section 4.3 - Contraindications
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.3, 4.4, 4.5, 4.6, 4.8
Detailed SPC change information: Added a warning that the combination of aliskiren-containing medicines and ACE inhibitors.
Updated on 24 September 2012
Reasons for updating
- Change to information about pregnancy or lactation
Updated on 12 June 2012
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4, 4.5, 4.6, 5.2, 10 - Added warnings on drug interactions; updated text on pregnancy and lactation
Updated on 11 February 2011
Reasons for updating
- Change to warnings or special precautions for use
Updated on 09 February 2011
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to section 4.5 - drug interactions (completion of II19) - Warnings on drug interactions
Updated on 08 June 2010
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 medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to section 6.5 and 10 - Harmonised pack sizes
Updated on 07 June 2010
Reasons for updating
- Change to further information section
Updated on 06 April 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Renewal completion - Sections 2, 3, 4.8, 6.1, 6.4, 6.5
Detailed SPC change information: Composition, Storage conditions
Updated on 29 March 2010
Reasons for updating
- Correction of spelling/typing errors
Updated on 17 November 2009
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on completion of variation to reduce shelf-life II/16
Sections: 3, 6.1, 6.3:
Shelf-life reduced to 2 years.
Pharmaceutical form description - minor editorial changes.
Excipients names amended.
Updated on 03 September 2009
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
No change to any sections. (Section 4.6 duplicated and incorrectly placed before Sec. 4.5)
Deletion of Section 4.6 inserted incorrectly before Section 4.5
Updated on 10 March 2009
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 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The changes are as a result of a variation to amend the following sections of the SmPC; 4.4 (Special warnings and special precautions for use), 4.6 (Pregnancy and lactation) and 5.2 (Pharmacokinetic properties) in response to the recommendation by the Pharmacovigilance Working Party regarding ACE inhibitors and lactation.
Updated on 06 February 2009
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The variation to include the term "syndrome of inappropriate antidiuretic hormone secretion" (SIADH) has been added to section 4.8 of the SmPC.
Updated on 03 September 2008
Reasons for updating
- Change to information about pregnancy or lactation
Updated on 27 August 2008
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
changed due to a variation to update pregnancy warning, sections 4.4 and 4.6 updated
Updated on 07 February 2008
Reasons for updating
- Change to information about pregnancy or lactation
- Change to drug interactions
- Change to side-effects
Updated on 23 August 2007
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
This update is due to changes in sections 4.4 and 4.5
Updated on 12 May 2006
Reasons for updating
- Change to warnings or special precautions for use
Updated on 27 March 2006
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 January 2006
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 November 2004
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 November 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 09 August 2004
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 21 February 2004
Reasons for updating
- Change to joint SPC covering all presentations
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)