Nebilet
*Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
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 06 April 2022
File name
ie-pl Nebilet clean Article 61-3 Approved March 22.pdf
Reasons for updating
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
Change to local representative details for Northern Ireland
Updated on 14 January 2022
File name
ie-spc Nebilet clean Approved Dec 21.pdf
Reasons for updating
- 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
Section 4.6 - Warnings on breast feeding updated and new section added on Fertility
Section 5.3 - New data added
Updated on 29 January 2019
File name
ie-pl Nebilet 103 approved clean 23-1-19.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 29 January 2019
File name
ie-spc Nebilet approved clean 23-1-19.pdf
Reasons for updating
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 6.1 List of excipients - E numbers added.
Updated on 17 May 2018
File name
ie_spc_Nebilet_clean_10_4_18_ipha.docx
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 medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 5.1 Pharmacodynamic properties
The following sentence has been added:
Available preclinical and clinical evidence in hypertensive patients has not shown that nebivolol has a detrimental effect on erectile function.
Section 10 Date of revision of the text
Updated to April 2018
Updated on 17 February 2015
File name
PIL_7903_960.pdf
Reasons for updating
- New PIL for new product
Updated on 17 February 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 February 2015
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 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 Undesirable effects
Add urticaria as a side-effect (frequency - not known)
Add HPRA details for the reporting of side-effects
Administrative amendments to align to the EU QRD template
Sections 2, 4.2, 4.3, 4.4, 9.
Section 10 Date of revision of the text
Updated to January 2015
Updated on 17 February 2015
Reasons for updating
- Change to side-effects
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 24 January 2012
Reasons for updating
- Change to date of revision
- Addition of manufacturer
Updated on 24 June 2011
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 31 March 2011
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 6.1 - List of excipients
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of baclofen in section 4.5 Interactions (under combinations to be used with caution), together with minor changes to the wording of sections 2, 3 and 6.1. Date of renewal and revision of the text updated in section 9 and 10.
Updated on 30 March 2011
Reasons for updating
- Change to storage instructions
- Change to drug interactions
- Change to further information section
- Change to date of revision
Updated on 24 July 2008
Reasons for updating
- Change to further information section
Updated on 05 June 2008
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 12 February 2008
Reasons for updating
- Change to side-effects
- Change to improve clarity and readability
Updated on 01 November 2007
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
Updated on 23 November 2006
Reasons for updating
- Change to packaging
Updated on 13 June 2006
Reasons for updating
- 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 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
- 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
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 13 June 2006
Reasons for updating
- 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 4.3 - Contraindications
- 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 5.3 - Preclinical safety data
- 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
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 13 June 2006
Reasons for updating
- Change to storage instructions
Updated on 03 April 2006
Reasons for updating
- Change to dosage and administration
Updated on 07 February 2006
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 February 2006
Reasons for updating
- Change to appearance of the medicine
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Change to dosage and administration
Updated on 15 September 2005
Reasons for updating
- Improved electronic presentation
Updated on 10 August 2004
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 August 2004
Reasons for updating
- New PIL for new product