Novolizer Budesonide 200 micrograms 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 Budesonide 200mcg 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 Budesonide 200mcg 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 Budesonide 200mcg PIL May 2018 - MAH Transfer - Clean.pdf
Reasons for updating
- New PIL for new product
Updated on 26 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 January 2018
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
Updated on 26 January 2018
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 19 June 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 4.4: Information regarding visual disturbance has been added.
In section 4.8: Blurred vision has been added to undesirable effects with frequency of not known
In section 10: The date of revision has been changed.
Updated on 19 June 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 4.4: Information regarding visual disturbance has been added.
In section 4.8: Blurred vision has been added to undesirable effects with frequency of not known
In section 10: The date of revision has been changed.
Updated on 11 April 2017
Reasons for updating
- 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
In section 4.5: Information regarding interaction with cobicistat-containing products has been added
In section 10: The date of revision has been changed.
Updated on 11 April 2017
Reasons for updating
- 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
Free text change information supplied by the pharmaceutical company
In section 4.5: Information regarding interaction with cobicistat-containing products has been added
In section 10: The date of revision has been changed.
Updated on 19 August 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 2: Minor text addition.
In section 4.6: Information added regarding pregnancy.
In section 4.8: Changes in frequency of some side effects. Side effects added.
In section 10: Date of revision changedUpdated on 19 August 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 2: Minor text addition.
In section 4.6: Information added regarding pregnancy.
In section 4.8: Changes in frequency of some side effects. Side effects added.
In section 10: Date of revision changedUpdated on 14 October 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
In section 4.2: change of text to refer to the elderly as ‘older people’
In section 4.8: Information on how to report adverse reactions and contact details of the IMB have been added
In section 10: The date of revision has been changed.
Updated on 14 October 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.2: change of text to refer to the elderly as ‘older people’
In section 4.8: Information on how to report adverse reactions and contact details of the IMB have been added
In section 10: The date of revision has been changed.
Updated on 26 June 2013
Reasons for updating
- 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 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 4.5: the following text has been added; These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress.
In section 4.6: the title has been changed to reflect the relevant SmPC structure
In section 4.8; small text changes has been made to the adverse table and reference to difficulty in swallowing has been replaced by throat irritation
In section 4.9: Additional information has been added
In section 10: the date of revision has changed
Updated on 26 June 2013
Reasons for updating
- 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 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.5: the following text has been added; These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress.
In section 4.6: the title has been changed to reflect the relevant SmPC structure
In section 4.8; small text changes has been made to the adverse table and reference to difficulty in swallowing has been replaced by throat irritation
In section 4.9: Additional information has been added
In section 10: the date of revision has changed
Updated on 14 January 2013
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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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
· In section 4.4; additional warnings and precautions for use have been added
· In section 4.5: additional information has been added regarding interaction with other medicinal products. In this section some text has also been removed
· In section 4.6: information has been expanded in relation to the use of budesonide in pregnancy and in breastfeeding
· In section 4.7: information has changed to show that budesonide has no effect on the ability to drive and operate machinery
· In section 4.8: the side effects table has been replaced and additional information has been added to this section. Information regarding the paediatric population has been added
· In section 4.9: the information regarding overdose has changed and the text in this section has been replaced with a single sentence which states that budesonide overdose is not expected to be a clinical problem
· In section 6.5: information that the product has been packed in a polypropylene container sealed by aluminium foil is added. Additional refill pack information has been added also to this section
· In section 10: the date of revision has changed
Updated on 14 January 2013
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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
· In section 4.4; additional warnings and precautions for use have been added
· In section 4.5: additional information has been added regarding interaction with other medicinal products. In this section some text has also been removed
· In section 4.6: information has been expanded in relation to the use of budesonide in pregnancy and in breastfeeding
· In section 4.7: information has changed to show that budesonide has no effect on the ability to drive and operate machinery
· In section 4.8: the side effects table has been replaced and additional information has been added to this section. Information regarding the paediatric population has been added
· In section 4.9: the information regarding overdose has changed and the text in this section has been replaced with a single sentence which states that budesonide overdose is not expected to be a clinical problem
· In section 6.5: information that the product has been packed in a polypropylene container sealed by aluminium foil is added. Additional refill pack information has been added also to this section
· In section 10: the date of revision has changed
Updated on 26 October 2011
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- 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
In section 4.4 the following text is added; and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
In section 4.8; changes have been made to the table; another column has been added for 'Not known'
In section 7; the MA address has changed
In section 10; the date of revision has changed
Updated on 26 October 2011
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.4 the following text is added; and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
In section 4.8; changes have been made to the table; another column has been added for 'Not known'
In section 7; the MA address has changed
In section 10; the date of revision has changed
Updated on 19 April 2011
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
Updated on 19 April 2011
Reasons for updating
- 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
In section 10; the date of revision has changed to April 2011
Updated on 19 April 2011
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Updated on 19 April 2011
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 10; the date of revision has changed to April 2011
Updated on 20 January 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 20 January 2011
Reasons for updating
- New SPC for medicines.ie