Sialanar 320 micrograms/ml Glycopyrronium (400 micrograms/ml Glycopyrronium Bromide) Oral Solution
*Company:
Proveca Pharma 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 12 September 2022
File name
SiaSmPC_EMA-EN_008_txt.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 April 2022
File name
SiaSmPC_EMA-EN_007_txt.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SmPC Section 7 update to MAH address.
Updated on 22 April 2022
File name
SiaSmPC_EMA-EN_007_txt.pdf
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
Change of MAH address.
Updated on 22 April 2022
File name
SiaPIL_EMA_EN_008_txt.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change to MAH address.
Updated on 30 June 2021
File name
SiaSmPC_EMA-EN_006_txt.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Changes following 5-year Renewal
Updated on 30 June 2021
File name
SiaPIL_EMA_EN_007_txt.pdf
Reasons for updating
- Change to Section 1 - what the product is
- 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 - use in children and adolescents
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Changes following 5-year Renewal
Updated on 11 December 2020
File name
SiaPIL_UK_IE_006_txt.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Addition of manufacturer
- Change to date of revision
Updated on 28 July 2020
File name
SiaSmPC_UK-IE_005_txt.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updates to Tables 1 and 2
Updated on 09 October 2019
File name
SiaPIL_UK-IE_005_txt.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 09 October 2019
File name
SiaSmPC_UK-IE_004_txt.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 April 2019
File name
Package Leaflet EN approved Apr 19.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 12 April 2019
File name
SiaSmPC_UK-IE_003_txt.pdf
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)
Updated on 31 January 2019
File name
Package Leaflet EN approved Jan 19.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 31 January 2019
File name
SmPC EN approved Jan 19.pdf
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 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- 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, the content of sodium benzoate has been added.
In section 4.4, sodium benzoate has been added.
In section 6.5, reference to the new 60 ml bottle has been added (in addition to the 250 ml) and the statement "Not all pack sizes may be marketed" included.
In section 8, the marketing authorisation number for the new 60 ml bottle presentation has been added.
In section 10, the data of the revision of the text has been updated.
Updated on 28 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 11 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 April 2018
File name
Sialanar PIL.pdf
Reasons for updating
- New PIL for new product