Rapamune 1mg and 2mg coated tablets
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 11 September 2024
File name
Adv SPC RA 18_0 tablets & oral sol IE clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 July 2022
File name
AdvSPCRA170tabletsoralsolIEclean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 July 2022
File name
AdvSPCRA170tabletsoralsolIEclean.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 July 2022
File name
AdvPILRA170tabletsIENIclean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 23 February 2022
File name
Adv PIL RA 16_0 tablets IE NI clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to other sources of information section
- Individual PILs superseded by joint PIL
Updated on 16 November 2021
File name
Adv SPC RA 16_0 tablets & oral sol IE clean.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: update of section 6.3 shelf life of Rapamune coated tablets 0.5 mg from 2 to 3 years.
Updated on 16 November 2021
File name
Adv PIL RA 15_0 tablets IE clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 20 July 2021
File name
DEC202149057_Adv SPC RA 15_0 tablets & oral sol IE clean.pdf
Reasons for updating
- 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 20 July 2021
File name
DEC202149057_Adv PIL RA 14_0 tablets IE 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 19 November 2020
File name
Adv SPC RA 14_0 tablets oral sol IE clean.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 November 2020
File name
Adv PIL RA 13_0 tablets IE clean (003).pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to MA holder contact details
Updated on 21 June 2019
File name
DEC201932722_Adv PIL RA 12_0 tablets UK IE_clean.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 21 June 2019
File name
DEC201932722_Adv SPC RA 13_0 tablet and Oral Sol UK IE_clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 6.2 - Incompatibilities
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: Correction of the amount of ethanol for the oral solution and update to the ammonium hydroxide information in Sections 2 and 6.2, repositioning of the sentence in Section 4.2 that treatment should be initiated by and remain under the guidance of an appropriately qualified specialist in transplantation, and minor correction regarding the excipient concentrated ammonium solution in section 6.2
Updated on 23 October 2018
File name
Adv PIL RA 11_0 tablets UK IE_clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 22 October 2018
File name
Adv SPC RA 12_0 tablet & oral sol UK_IE-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
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.
SPC section 7: Marketing authorisation holder change to Pfizer EEIG.
Updated on 03 October 2018
File name
Adv PIL RA 10_0 tablets UK-IE-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 03 October 2018
File name
Adv SPC RA 11_0 tablet & oral sol UK_IE-clean.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.
Updated on 14 August 2018
File name
Adv PIL RA 9_0 tablets UK_IE-clean corrected.pdf
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 3 - how to take/use
- 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 09 August 2018
File name
Adv SPC RA 10_0 tablet_oral sol UK_IE-clean.pdf
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 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:
Section
Section 4.1 Indication. – New indication for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function
Section 2 Posology patients with sporadic lymphangioleiomyomatosis
Section 4.4 clarification on warnings relating to only renal transplant patients
Section 4.8 Clarification on undesirable effects observed with prophylaxis of organ rejection in renal transplantation
Section 4.8 Undesirable effects observed with patients with S-LAM
Section 5..1 and 5.2 Clinical data on treatment of sporadic lymphangioleiomyomatosis
Updated on 08 August 2018
File name
Adv PIL RA 9_0 tablets UK_IE-clean.pdf
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 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 08 August 2018
File name
Adv SPC RA 10_0 tablet_oral sol UK_IE-clean.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
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
Section 4.8 AE reporting details for UK.
Updated on 05 June 2018
File name
Adv_SPC_RA_9_0_oral_sol_UK_IE_clean.docx
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
The SPC has been updated as follows:
Section 2, 3, 4.2, 4.4, 4.8, 5.2, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, and 8.
Updated on 27 March 2017
File name
PIL_14886_430.pdf
Reasons for updating
- New PIL for new product
Updated on 27 March 2017
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 23 October 2015
Reasons for updating
- Change of inactive ingredient
Updated on 26 June 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
- Change to MA holder contact details
Updated on 01 April 2015
Reasons for updating
- PIL re-instated
Updated on 23 March 2015
Reasons for updating
- Change to side-effects
- Change to date of revision
- Addition of manufacturer
Updated on 05 August 2013
Reasons for updating
- Change to marketing authorisation holder
Updated on 02 August 2013
Reasons for updating
- Change to marketing authorisation holder
Updated on 21 January 2013
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to further information section
- Change to date of revision
- Change to MA holder contact details
Updated on 04 August 2011
Reasons for updating
- Change to marketing authorisation holder
Updated on 08 April 2011
Reasons for updating
- Change to name of manufacturer
Updated on 01 February 2011
Reasons for updating
- Change to MA holder contact details
Updated on 19 January 2011
Reasons for updating
- New PIL for medicines.ie