Novolizer Salbutamol 100 micrograms/dose inhalation powder
*Company:
Mylan IRE Healthcare 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 14 June 2019
File name
Novolizer Salbutamol SmPC May 2018 - MAH Transfer - Clean.pdf
Reasons for updating
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 June 2018
File name
Novolizer Salbutamol SmPC May 2018 - MAH Transfer - Clean.docx
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)
Updated on 19 June 2018
File name
Novolizer Salbutamol PIL May 2018 - MAH Transfer - Clean.pdf
Reasons for updating
- New PIL for new product
Updated on 18 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 January 2018
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 18 January 2018
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 12 October 2015
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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
In section 4.6: Additional information regarding pregnancy, fertility and breast-feeding has been added.
In section 5.3: Additional preclinical safety data has been added.
In section 10: The date of revision has been changed.
Updated on 12 October 2015
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.6: Additional information regarding pregnancy, fertility and breast-feeding has been added.
In section 5.3: Additional preclinical safety data has been added.
In section 10: The date of revision has been changed.
Updated on 12 November 2013
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 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
In section 4.1: Additional text has been added to the indication referring to the age categories
In section 4.2: the term elderly has been changed to ‘older’
In section 4.4: Additional warning has been added in relation to acute asthma attacks or exacerbation of severe asthma
In 4.6: the title of this sub-heading has been expanded to include pregnancy
In section 4.8: additional of text and removal of other obsolete text. Information added regarding the reporting of adverse events.
In section 10: date of revision has changed
Updated on 12 November 2013
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.1: Additional text has been added to the indication referring to the age categories
In section 4.2: the term elderly has been changed to ‘older’
In section 4.4: Additional warning has been added in relation to acute asthma attacks or exacerbation of severe asthma
In 4.6: the title of this sub-heading has been expanded to include pregnancy
In section 4.8: additional of text and removal of other obsolete text. Information added regarding the reporting of adverse events.
In section 10: date of revision has changed
Updated on 28 June 2011
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 28 June 2011
Reasons for updating
- New SPC for medicines.ie