Paxlovid 150 mg + 100 mg film-coated tablets
*Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 11 March 2024
File name
Adv PIL PX 16_0 IE N Iclean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 12 January 2024
File name
AdvSPCPX170IEclean.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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: update in section 4.4 to clarify that SJS and TEN have been reported with Paxlovid, and in section 4.8 to add the ADRs Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Updated on 12 January 2024
File name
AdvPILPX150IENIclean.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 - date of revision
Updated on 22 November 2023
File name
Adv SPC PX 16 0 IE clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 November 2023
File name
Adv PIL PX 14 0 IE NI clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 22 November 2023
File name
Adv PIL PX 14 0 IE NI clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 30 October 2023
File name
Adv SPC PX 15_0 IE clean.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 October 2023
File name
Adv SPC PX 15_0 IE clean.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 October 2023
File name
Adv PIL PX 13_0 IE NI 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 11 October 2023
File name
Adv SPC PX 140 IE clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 October 2023
File name
Adv PIL PX 120 IE NI clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 15 August 2023
File name
Adv SPC PX 130 IE clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2023
File name
AdvSPCPX120IEclean.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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Sections 4.4 and 4.8 to add a warning on the risk of hypertension and to recommend a monitoring of blood pressure and to add ‘hypertension’ to the list of ADRs.
Updated on 27 June 2023
File name
AdvPILPX110IENIclean.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 - date of revision
Updated on 28 April 2023
File name
Adv SPC PX 11_0 IE clean.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 April 2023
File name
Adv PIL PX 10_0 IE NI clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 28 February 2023
File name
AdvSPCPX100IEclean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: update to section 5.1 to remove the mention to a conditional approval following conversion to full MA.
Updated on 28 February 2023
File name
AdvPILPX90IENIclean.pdf
Reasons for updating
- Change to other sources of information section
Updated on 17 February 2023
File name
AdvSPCPX90IEclean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: update to sections 4.2, 4.6, 4.8, 5.1 and 5.2 following updates related to the latest non-clinical virology and toxicology data, pertinent clinical pharmacology information, and final clinical efficacy and safety data from the studies C4671005 (EPIC-HR) and C4671006 (EPIC-PEP) and interim data from study C4671002 (EPIC-SR). Change in line with CDS v5.
Updated on 17 February 2023
File name
AdvPILPX80IENIclean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 26 January 2023
File name
Adv SPC PX 8_0 IE clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 January 2023
File name
Adv PIL PX 7_0 IE NI clean.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 23 December 2022
File name
AdvSPCPX70IEclean.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 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: sections 4.3, 4.4, 4.5 and 5.2 to include results from the DDI studies C4671013 and C4671012; Sections 4.4 and 4.8 to include new ADRs hypersensitivity and anaphylaxis.
Updated on 23 December 2022
File name
AdvPILPX60IENIclean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- 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 4 - possible side effects
- Change to section 6 - date of revision
Updated on 02 November 2022
File name
AdvSPCPX60IEclean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 November 2022
File name
AdvPILPX50IENIclean (1).pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
Updated on 24 October 2022
File name
Adv SPC PX 5_0 IE clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 October 2022
File name
Adv PIL PX 4_0 IE NI clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 20 September 2022
File name
AdvSPCPX40IEclean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: Section 6.3 shelf-life update to 18 months.
Updated on 16 August 2022
File name
Adv SPC PX 3_0 IE clean.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 July 2022
File name
Adv SPC PX 2_0 IE clean.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 July 2022
File name
Adv PIL PX 3_0 IE NI 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 26 April 2022
File name
AdvPILPX20IENIclean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 02 March 2022
File name
Adv SPC PX 1_0 IE.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Peoduct Launch 10 March 2022
Updated on 02 March 2022
File name
Adv PIL PX 1_0 IE NI.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Product Launch 10 March 2022