Atozet 10mg/10mg, 10mg/20mg, 10mg/40mg and 10mg/80mg film-coated tablets
*Company:
Organon Pharma (Ireland) LimitedStatus:
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 12 July 2023
File name
Atozet-DE-H-3895-001-004-WS-1385-SPC-IE-en-CRT.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 July 2023
File name
ATOZET-DE-H-3895-001-004-WS-1385-PIL-IE-en-CRT.pdf
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 - manufacturer
Updated on 19 May 2023
File name
ATOZET-DE-H-3895-001-004-IA-035-G-PIL-IE-en-CRT.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 16 May 2023
File name
ATOZET-DE-H-3895-001-004-IA-1323-G-PIL-IE-en-CRT-HAARLEM and HEIST.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 26 January 2023
File name
Atozet-DE-H-3895-MAT Oct21-SPC-IE-en-CRT.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 January 2023
File name
Atozet-DE-H-xxxx-MAT Oct21-SPC-IE-en-CRT.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 October 2021
File name
Atozet-DE-H-xxxx-MAT Oct21-SPC-IE-en-CRT.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 October 2021
File name
QRD-IE-Atozet-LFT-CRT.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 30 September 2020
File name
Atozet SPC WS-673 CRT_ (002).pdf.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.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).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).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).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).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).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.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).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.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.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.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
File name
PIL_16308_417.pdf
Reasons for updating
- New PIL for new product
Updated on 14 November 2017
Reasons for updating
- Change to section 6 - date of revision
- Correction of spelling/typing errors
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 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
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
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
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
Updated on 08 May 2015
Reasons for updating
- New PIL for new product