Onglyza 5 mg Film-Coated Tablets
*Company:
AstraZeneca Pharmaceuticals (Ireland) DACStatus:
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 19 September 2023
File name
20230914 SPC IE MT Onglyza 2.5 mg 5 mg Film-Coated Tablets Removal of NI Details Sept 2023 CV 23 0028.pdf
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
Removal of Northern Ireland adverse reporting details
Updated on 19 September 2023
File name
20230914 SPC IE MT Onglyza 2.5 mg 5 mg Film-Coated Tablets Removal of NI Details Sept 2023 CV 23 0028.pdf
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
Removal of Northern Ireland adverse reporting details
Updated on 19 September 2023
File name
20230914 SPC IE MT Onglyza 2.5 mg 5 mg Film-Coated Tablets Removal of NI Details Sept 2023 CV 23 0028.pdf
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
Removal of Northern Ireland adverse reporting details
Updated on 19 September 2023
File name
20230914 SPC IE MT Onglyza 2.5 mg 5 mg Film-Coated Tablets Removal of NI Details Sept 2023 CV 23 0028.pdf
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
Removal of Northern Ireland adverse reporting details
Updated on 13 April 2023
File name
20230406 Package Leaflet IE MT Onglyza 5 mg Film-Coated Tablets Swedish Postcode Update CV 23 0015.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 24 January 2023
File name
20211126 SPC IE MT Ongylza 2.5mg 5mg Film-Coated Tablets NI Details, BR Site CV 21 0041.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 December 2021
File name
20211126 Package Leaflet IE MT Onglyza 5mg Film-Coated Tablets NI Detail CV 21 0043.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Inserted text, Deleted text
[..]
4. Possible side effects
[..]
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
[..]
United Kingdom (Northern Ireland)
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
[..]
6. Contents of the pack and other information
[..]
Manufacturer:
[..]
AstraZeneca GmbH
Tinsdaler Weg 183
22880 Wedel
Germany
[..]
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
[..]
|
United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 836 |
|
This leaflet was last revised in 02/2021 11/2021
Updated on 03 December 2021
File name
20211126 SPC IE MT Ongylza 2.5mg 5mg Film-Coated Tablets NI Details, BR Site CV 21 0041.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Inserted text, Deleted text
[..]
4.8 Undesirable effects
[..]
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
[..]
United Kingdom (Northern Ireland)
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
[..]
8. MARKETING AUTHORISATION NUMBER(S)
Onglyza 2.5 mg film coated tablets
EU/1/09/545/011-015 14 film-coated tablets (calendar blister)
EU/1/09/545/012 28 film-coated tablets (calendar blister)
EU/1/09/545/013 98 film-coated tablets (calendar blister)
EU/1/09/545/014 30x1 (unit dose) film-coated tablets
EU/1/09/545/015 90x1 (unit dose) film-coated tablets
Onglyza 5 mg film coated tablets
EU/1/09/545/001-010 14 film-coated tablets
EU/1/09/545/002 28 film-coated tablets
EU/1/09/545/003 56 film-coated tablets
EU/1/09/545/004 98 film-coated tablets
EU/1/09/545/005 14 film-coated tablets (calendar blister)
EU/1/09/545/006 28 film-coated tablets (calendar blister)
EU/1/09/545/007 56 film-coated tablets (calendar blister)
EU/1/09/545/008 98 film-coated tablets (calendar blister)
EU/1/09/545/009 30x1 (unit dose) film-coated tablets
EU/1/09/545/010 90x1 (unit dose) film-coated tablets
[..]
10. DATE OF REVISION OF THE TEXT
12th March 2020 26th November 2021
Updated on 24 February 2021
File name
20210223 Package Leaflet IE MT Onglyza Film-Coated Tablets 5mg BR Site Update CV 21 0011.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 19 March 2020
File name
20200312 Package Leaflet IE MT Ongylza 5 mg Film-Coated Tablets Bullous Pemphigoid CV 20 0010.pdf
Reasons for updating
- New PIL for new product
Updated on 19 March 2020
File name
20200312 SPC IE MT Onglyza 2.5 mg 5 mg Film-Coated Tablets Bullous Pemphigoid CV 20 0008.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)