Tracrium 10mg/ml, Solution for Injection or Infusion, ampoules
*Company:
AspenStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 20 November 2023
File name
Atra_Inj_IE_P_10mg-ml_v8.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 06 September 2023
File name
Atra_Inj_IE_S_10mg-ml_2.5ml5ml_v3.pdf
Reasons for updating
- 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 not be renewed (A)
Updated on 06 September 2023
File name
Atra_Inj_IE_P_10mg-ml_v7.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 12 June 2023
File name
Atra_Inj_IE_S_10mg-ml_2.5ml5ml_v2.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 June 2023
File name
Atra_Inj_IE_P_10mg-ml_v6.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 08 August 2022
File name
Atra_Inj_IE_P_10mg-ml_v5.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change of manufacturer
Updated on 16 June 2020
File name
Atra_Inj_IE_P_10mg-ml_v4.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to date of revision
Updated on 23 May 2019
File name
Atra_Inj_IE_P_10mg-ml_Combined_v3.pdf
Reasons for updating
- New PIL for new product
Updated on 22 May 2019
File name
Atra_Inj_IE_S_10mg-ml_2.5ml5ml_Aug2017_v1 ampoules.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 August 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 August 2017
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Text in red = new text
Text strikethrough = deleted text
7. MARKETING AUTHORISATION HOLDER
GlaxoSmithKline (Ireland) Limited
12 Riverwalk,
Citywest Business Campus,
Dublin 24
Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24,
Ireland
8. MARKETING AUTHORISATION NUMBER
PA 1077/81/1 PA 1691/029/001
10. DATE OF (PARTIAL) REVISION OF THE TEXT
28 Jan 2016 August 2017
Updated on 16 August 2017
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Text in red = new text
Text strikethrough = deleted text
7. MARKETING AUTHORISATION HOLDER
GlaxoSmithKline (Ireland) Limited
12 Riverwalk,
Citywest Business Campus,
Dublin 24
Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24,
Ireland
8. MARKETING AUTHORISATION NUMBER
PA 1077/81/1 PA 1691/029/001
10. DATE OF (PARTIAL) REVISION OF THE TEXT
28 Jan 2016 August 2017
Updated on 02 February 2016
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
QRD V9 updates to the following sections:
4.2 Posology and method of administration
4.3 Contraindications
4.8 Undesirable effects
Updated on 02 February 2016
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Change to section 4.2 - Posology and method of administration
Free text change information supplied by the pharmaceutical company
QRD V9 updates to the following sections:
4.2 Posology and method of administration
4.3 Contraindications
4.8 Undesirable effects
Updated on 15 July 2015
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 15 July 2015
Reasons for updating
- 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
Updated on 07 April 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.5 - spelling and grammer changes throughout
Section 5.1 - addition of headings, addition of ATC code
Section 5.2 - addition of headings and reformatting
Section 6.4 - additional wording on precautions for storage
Updated on 07 April 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 4.5 - spelling and grammer changes throughout
Section 5.1 - addition of headings, addition of ATC code
Section 5.2 - addition of headings and reformatting
Section 6.4 - additional wording on precautions for storage
Updated on 31 March 2014
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 5.1 - additional wording on paediatric population
Updated on 31 March 2014
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
Section 5.1 - additional wording on paediatric population
Updated on 18 September 2013
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 - Special warnings and precautions for use,
Section 4.5 - Interaction with other medicinal products and other forms of interaction,
Section 4.6 - Pregnancy and lactation,
Section 4.7 - Effects on ability to drive and use machines,
Section 6.6 - Special precautions for disposal
Updated on 18 September 2013
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Free text change information supplied by the pharmaceutical company
Section 4.4 - Special warnings and precautions for use,
Section 4.5 - Interaction with other medicinal products and other forms of interaction,
Section 4.6 - Pregnancy and lactation,
Section 4.7 - Effects on ability to drive and use machines,
Section 6.6 - Special precautions for disposal