Tracrium 10mg/ml, Solution for Injection or Infusion, ampoules

  • Name:

    Tracrium 10mg/ml, Solution for Injection or Infusion, ampoules

  • Company:
    info
  • Active Ingredients:

    Atracurium Besylate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/05/19

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Summary of Product Characteristics last updated on medicines.ie: 22/5/2019

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Aspen

Aspen

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1 - 0 of 63 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 23 May 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 22 May 2019 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 16 August 2017 SmPC

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 PIL

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 2 February 2016 PIL

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 2 February 2016 SmPC

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 15 July 2015 SmPC

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

Section 7 - change to Ireland MAH address

Updated on 15 July 2015 PIL

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

Section 7 - change to Ireland MAH address

Updated on 7 April 2014 SmPC

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 4.2 - reformatting eg "use in children" replaced "children"

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 7 April 2014 PIL

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 4.2 - reformatting eg "use in children" replaced "children"

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 PIL

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 4.2 - additional wording on use in neonates
Section 5.1 - additional wording on paediatric population

Updated on 31 March 2014 SmPC

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 4.2 - additional wording on use in neonates
Section 5.1 - additional wording on paediatric population

Updated on 18 September 2013 PIL

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Free text change information supplied by the pharmaceutical company

Changes to:

 

 

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 SmPC

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

Changes to:

 

 

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