Eklira Genuair 322 micrograms inhalation powder
*Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)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 12 October 2023
File name
Eklira-SmPC_clean approved Dec 2022.pdf
Reasons for updating
- 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
Change of MAH from AZ to Covis.
Updated on 12 October 2023
File name
Eklira-PIL_clean approved Jan 2023.pdf
Reasons for updating
- Change to marketing authorisation holder
Free text change information supplied by the pharmaceutical company
MAH transfer from AZ to Covis
Updated on 09 January 2023
File name
ie-smpc Eklira PI update clean 14-11-19.pdf
Reasons for updating
- Previous version of SPC reinstated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 January 2023
File name
ie-pil Eklira IFU clean UK NI update 1 Dec 21.pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 09 January 2023
File name
ie-smpc Eklira Clean - MAH Transfer Dec 22.pdf
Reasons for updating
- 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
MAH Updated from Astra Zeneca to Covis
Updated on 09 January 2023
File name
ie-pil-Eklira Clean - MAH Transfer Dec 22.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
MAH holder updated from Astra Zeneca to Covis
Updated on 17 December 2021
File name
ie-pil Eklira IFU clean UK NI update 1 Dec 21.pdf
Reasons for updating
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Added details for United Kingdom Northern Ireland as pack as been shared with the United Kingdom.
Updated on 04 February 2020
File name
ie-pil Eklira IFU clean 14-11-19.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Revisions made to align with the SmPC and minor editorial changes
Updated on 04 February 2020
File name
ie-smpc Eklira PI update clean 14-11-19.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The main changes are as folows:
- 4.1 Therapeutic Indication - Inclusion of Cross reference to Section 5.1 as a result of the ASCENT study revisions
- 4.4 Special Warnings and Precautions for Use - Cardiovascular effects. Revisions as a result of the ASCENT study
- 4.8 Undesirable effects - Inclusion of data from the ASCENT study
- 5.1 Pharmacodynamic effects, Clinical efficacy and safety - Inclusion of data from the ASCENT study
Updated on 30 August 2018
File name
ie-pil Eklira IFU clean 30-8-18.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 30 August 2018
File name
ie-smpc Eklira new IFU clean 22-2-18.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 May 2018
File name
ie_smpc_Eklira_new_IFU_clean_22_2_18.docx
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
The Instructions for Use have been moved from section 4.2 to 6,6 and have been updated.
Updated on 04 May 2018
File name
ie-pil Eklira IFU clean 22-2-18.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to further information section
Updated on 22 June 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 June 2017
Reasons for updating
- Change to section 4.3 - Contraindications
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.3 Contraindications updated to :
Hypersensitivity to aclidinium bromide or to the excipients listed in section 6.1.
The following hypersensitivities are removed: atropine or its derivatives, including ipratropium, oxitropium or tiotropium
Updated on 16 May 2017
File name
PIL_15969_883.pdf
Reasons for updating
- New PIL for new product
Updated on 16 May 2017
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - 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
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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
- 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 the SmPC following licence renewal and update to section 4.3 Contra-indications
· Administrative updates to section 2, 4.2. 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2, 5.3, 6.4, 6.5
· 4.3 Contraindications
Removal of hypersensitivity to atropine or its derivatives, including ipratropium, oxitropium or tiotropium.
· 4.4 Special warnings and precautions
Warning on asthma removed.
· 4.6 Pregnancy and lactation
Addition of ‘A risk to newborns/infants cannot be excluded’.
· 9 Date of last renewal added
· 10. Date of revision updated
Updated on 16 May 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 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 06 December 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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 4.2 Posology and method of administration: Update in line with current QRD
Change to section 4.8 Undesirable effects: Inclusion of side effect: Anaphylactic reaction (frequency not known)
Change to section 5.2 Pharmacokinetic properties: Update to pharmacokinetic data (absorption, elimination and race sections)
Change to section 5.3 Preclinical safety data: Update to preclinical safety data
Change to section 10 Update to date of revision of text
Updated on 06 December 2016
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 19 May 2015
Reasons for updating
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- 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
- changes in section 4.7 Effects on ability to drive and use machines
- new side-effects in section 4.8; Dizziness as uncommon, Nausea as common and Stomatitis as uncommon.
Updated on 19 May 2015
Reasons for updating
- Change to side-effects
- Change to information about driving or using machinery
- Change to date of revision
Updated on 24 March 2015
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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
AstraZeneca AB
SE-151 85 Sdertlje
Sweden
Section 10 Date of revision of the text
Updated to 5 March 2015
Updated on 24 March 2015
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
- Change to MA holder contact details
Updated on 24 February 2015
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 10 Date of Revision
Update to 11/2014
Updated on 24 February 2015
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 05 June 2014
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 6.4 - Special precautions for storage
- 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
The changes relate to the following sections of the SmPC:
- Section 4.8 - "hypersensitivity reactions", "angioedema", "rash" and "pruritus" have been included as ADRs
- Section 6.4 and 6.5 - change to the wording relating to the introduction of a plastic pouch
- Section 10 - the date of revision is updated.
Updated on 05 June 2014
Reasons for updating
- Change to storage instructions
- Change to side-effects
- Change to appearance of the medicine
- Change of distributor details
- Change to name of manufacturer
Updated on 03 April 2014
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 03 April 2014
Reasons for updating
- New PIL for new product