Atozet 10mg/10mg, 10mg/20mg, 10mg/40mg and 10mg/80mg film-coated tablets

Product Information *

  • Company:

    Organon Pharma (Ireland) Limited
  • Status:

    Updated
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 30 September 2020

File name

Atozet SPC WS-673 CRT_ (002).pdf_1601459705.pdf

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)

Free text change information supplied by the pharmaceutical company

SPC updated to include a statement on sodium content

 

Updated on 30 September 2020

File name

Atozet PIL WS-673 CRT (002).pdf_1601459421.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Updated on 10 January 2020

File name

ATOZET-DE-H-3895-3898-001-004-WS-612-PL-IE-en-CRT (clean) (002)_1578661855.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 10 January 2020

File name

ATOZET-DE-H-3895-3898-001-004-WS-612-SPC-IE-en-CRT (clean) (002)_1578661344.pdf

Reasons for updating

  • 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 5.2 - Pharmacokinetic properties
  • 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

Updates to sections 4.4 – Special warnings and precautions for use, 4.5 – Interaction with other medicinal products and other forms of interaction, 4.6 – Fertility, pregnancy and lactation, 5.2 – Pharmacokinetic properties and 10. Date of revision following approval of WS612 Daptomycin concomitant administration

Updated on 18 October 2019

File name

ATOZET-DE-H-3895-3898-001-004-WS-613-SPC-IE-en-CRT (002)_1571388880.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

Correction to section 4.8

Updated on 25 September 2019

File name

ATOZET PIL Sept 2019 WS613 (clean) (002)_1569400389.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

PIL change to section 2 - interactions with other medicines, food or drink, Change to section 3 - how to take/use, Change to section 4 - possible side effects, Change to section 6 - date of revision

 

Updated on 20 September 2019

File name

ATOZET-DE-H-3895-3898-001-004-WS-613-SPC-IE-en-CRT (clean).doc (002)_1568974663.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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Updates to section 4.8 Undesirable effects and section 10. Date of revision following approval of WS/613 - PRAC recommendation regards to Lupus-like Syndrome

 

Updated on 13 August 2019

File name

ATOZET QRD clean PIL IA983 PRAC Urine discolouration_1565703965.pdf

Reasons for updating

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

Updated on 31 July 2019

File name

ATOZET-DE-H-3895-3898-001-004-WS-609-SPC-IE-en-CRT (002)_1564585013.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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Updates to section 4.8 Undesirable effects and section 10. Date of revision following approval of WS609 PRAC Muscle Rupture

 

Updated on 12 April 2019

File name

ATOZET-DE-H-3895-3898-001-004-R001-SPC-IE-en-CRT_1555062551.pdf

Reasons for updating

  • 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 to 9. Date of first authorisation/renewal of authorisation

 

Updated on 22 March 2019

File name

ATOZET QRD PIL WS566 Antivirals clean_1553247587.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 14 March 2019

File name

ATOZET-DE-H-3895-3898-001-004-WS-566-SPC-IE-en-CRT_1552583765.pdf

Reasons for updating

  • 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 5.2 - Pharmacokinetic properties
  • 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

Updates to SPC following approval of WS566 - Interactions with antivirals

Updated on 20 July 2018

File name

ATOZET QRD PIL WS385 MAT Brexit (2).pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 10 July 2018

File name

ATOZET-DE-H-3895-001-004-NAT-20180622-PI-IE-en-CRT (2).docx

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes to 7. Marketing Authorisation Holder  and Section 10 – Date of revision of the text following approval of MA Transfer

Updated on 14 November 2017

Reasons for updating

  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 14 November 2017

File name

PIL_16308_417.pdf

Reasons for updating

  • New PIL for new product

Updated on 08 November 2017

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Updates to sections 4.5 and 10 and Correction of spelling/typing errors  and Improved presentation of SPC as a result of approval of Type II variation (DE/H/xxxx/WS/385) DDI xref Safety Label Update

Updated on 08 November 2017

Reasons for updating

  • New SPC for new product

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

Updated on 11 May 2017

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 02 May 2017

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Updates to sections 4.2, 4.4, 4.5, 5.2 and 10 as a result of approval of Type II variation (DE/H/xxxx/WS/335) DDI of BCRP inhibitors with HMG-CoA reductase inhibitors (statins)

Updated on 06 May 2016

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

Sections   4.4 & 4.5 
SPC Change Details: to include a warning on concomitant use with fusidic acid

Updated on 05 May 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions

Updated on 12 February 2016

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

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

Free text change information supplied by the pharmaceutical company

Tell us all the sections of your SPC that have changed: 4.1, 4.2, 4.4, 4.8, 5.1

SPC Change Details: In section 4.1, a new indication for “Prevention of Cardiovascular Events” has been added (with corresponding updates to other sections)

Updated on 11 February 2016

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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

SPC Change Details  4.1, 4.2, 4.4, 4.8, 5.1
In section 4.1, a new indication for “Prevention of Cardiovascular Events” has been added (with corresponding updates to other sections)

Updated on 11 February 2016

Reasons for updating

  • Changes to therapeutic indications

Updated on 15 July 2015

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)

Free text change information supplied by the pharmaceutical company

Change to Section 4.4 - Special warnings and precautions for use, Change to Section 4.8 - Undesirable effects and Change to Section 10 - Date of revision of the text
Brief outline of changes to SPC sections listed above
Update to PI according to PRAC recommendation on IMNM

Updated on 14 July 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 11 May 2015

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 08 May 2015

Reasons for updating

  • New PIL for new product