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Forxiga 10 mg Film coated tablets

  • Name:

    Forxiga 10 mg Film coated tablets

  • Company:
    info
  • Active Ingredients:

    Dapagliflozin propanediol monohydrate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/04/21

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Summary of Product Characteristics last updated on medicines.ie: 12/4/2021

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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

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1 - 0 of 45 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 12 April 2021 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Green = added text

Red = deleted text

...

What Forxiga looks like and contents of the pack

...

Forxiga 10 mg tablets are available in aluminium blisters in pack sizes of 10 film-coated tablets in
non-perforated blisters, 14, 28 or 98 film-coated tablets in non-perforated calendar blisters and 10x1,
30x1 or 90x1 film-coated tablets in perforated unit dose blisters.

...

Date of Revision updated to 04/2021

 

Updated on 12 April 2021 SPC

Reasons for updating

  • 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

Green = added text

Red = deleted text

...

6.5       Nature and contents of container

Pack size of 10 film-coated tablets in non-perforated blisters.

Pack sizes of 14, 28 and 98 film‑coated tablets in non‑perforated calendar blisters.

Pack sizes of 10x1, 30x1 and 90x1 film‑coated tablets in perforated unit dose blisters.

...

8.         MARKETING AUTHORISATION NUMBER(S)

...

EU/1/12/795/011 10 x 1 (unit dose) film-coated tablets

...

10.       DATE OF REVISION OF THE TEXT

6th April 2021

 

Updated on 4 February 2021 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 21 January 2021 SPC

Reasons for updating

  • Other

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 20 November 2020 SPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

6.5       Nature and contents of container

Alu/Alu blister

Pack size of 10 film-coated tablets in non-perforated blisters.

Pack sizes of 14, 28 and 98 film‑coated tablets in non‑perforated calendar blisters.

Pack sizes of 30x1 and 90x1 film‑coated tablets in perforated unit dose blisters.

[..]

  1.          MARKETING AUTHORISATION NUMBER(S)

[..]

EU/1/12/795/011 10 film-coated tablets

[..]

Updated on 20 November 2020 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Free text change information supplied by the pharmaceutical company

What Forxiga looks like and contents of the pack

[..]

Forxiga 10 mg tablets are available in aluminium blisters in pack sizes of 10 film-coated tablets in non-perforated blisters, 14, 28 or 98 film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.

Updated on 6 November 2020 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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)

Updated on 6 November 2020 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 12 December 2019 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 25 October 2019 SPC

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)

Updated on 25 October 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 9 August 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 9 August 2019 SPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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)

Updated on 20 June 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 19 June 2019 SPC

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 be renewed (B)

Updated on 19 June 2019 SPC

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 be renewed (B)

Updated on 4 April 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 April 2019 SPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 3 April 2019 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)