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Revatio 10 mg/ml powder for oral suspension

*
Pharmacy Only: Prescription

  • Company:

    Upjohn EESV

  • Status:

    Updated

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Sildenafil Citrate

    *Additional information is available within the SPC or upon request to the company

Updated on 22 March 2024

File name

Summary of Product Characteristics - 10mg per ml POS - TII098 - clean .pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 11 - Dosimetry

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 23 March 2023

File name

Revatio 10 mgml Powder for Oral Suspension - Patient Information Leaflet.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer

Updated on 05 August 2022

File name

DEC202209217-V_Adv PIL RV POS 27_0 IE UK (NI) - clean.pdf

Reasons for updating

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

Updated on 26 May 2022

File name

Adv SPC RV POS 23_1 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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.5 Interaction with other medicinal products and other forms of interaction – addition of wording relating to sacubitril/valsartan

Updated on 04 May 2022

File name

DEC202204975-V_Adv SPC RV POS 24_1 IE - clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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:

Section 4.8 & 5.1 to include long term safety data in adults for the approved dose, and evidence of safe and effective use in adults in higher than recommended doese.

Updated on 08 April 2022

File name

Adv SPC RV POS 23_1 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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.5 Interaction with other medicinal products and other forms of interaction – addition of wording relating to sacubitril/valsartan 

Updated on 08 April 2022

File name

Adv PIL RV POS 26_1 IE UK (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 03 March 2022

File name

Adv PIL RV POS 25_0 IE UK (NI) - clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Individual PILs superseded by joint PIL

Updated on 18 November 2020

File name

DEC202050566-V_Adv SPC RV POS 22_1 IE - Clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 18 November 2020

File name

DEC202050566-V_Adv PIL RV POS 24_1 IE - Clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 18 November 2020

File name

DEC202050566-V_Adv SPC RV POS 22_1 IE - Clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 09 June 2020

File name

DEC202037533_Adv SPC RV POS 21_1 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 to change the MAH in section 7 from Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium to Upjohn EESV, Rivium Westlaan 1422909 LD Capelle aan den Ijssel,Netherlands.  

Updated on 09 June 2020

File name

DEC202037533_Adv PIL RV POS 23_1 IE.Clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Joint PIL superseded by individual PILs

Updated on 09 April 2020

File name

DEC202023178_Adv SPC RV POS 20_1 IE Clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 09 April 2020

File name

DEC202023178_Adv PIL RV POS 22_1 UK IE Clean.pdf

Reasons for updating

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

Updated on 19 November 2019

File name

DEC201964508_Adv PIL RV POS 21_0 UK IE.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 29 May 2019

File name

Adv PIL RV POS 20_0 UK IE.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 29 May 2019

File name

Adv SPC RV POS 19_0 IE.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 August 2018

File name

Adv PIL RV POS 19_1 UK IE_clean.pdf

Reasons for updating

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

Updated on 03 August 2018

File name

Adv SPC RV POS 18_1 IE_clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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 7: Marketing Authorisation Holder updated to new MAH, Pfizer EEIG, Belgium.

Section 10: Date of Revision of Text updated to 07/2018

Updated on 10 May 2018

File name

Adv_SPC_RV_POS_17_0_IE_clean.docx

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

UK brand marketing

Not affected

Note – as this is a CP licensed product, the SPC revision date has been updated to reflect the EMA approval date (04/2018)

Updated on 26 April 2018

File name

Adv PIL RV POS 18_0 UK IE_clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 11 December 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 11 December 2017

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC (UK and IE) has been updated as follows: Section 4.6 Breast Feeding updated.

Updated on 07 December 2017

File name

PIL_15490_59.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 December 2017

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 05 August 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

section 4.2 has been updated to delete information related to the extemporaneously prepared oral suspension.

Updated on 03 August 2016

Reasons for updating

  • Change to storage instructions
  • Change to dosage and administration

Updated on 23 June 2016

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 10 The revision date has been updated to 06/2016 in line with the date of the EMA annexes.

Updated on 22 June 2016

Reasons for updating

  • Change to date of revision

Updated on 17 November 2015

Reasons for updating

  • Change to section 6.1 - List of excipients

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 6.1 update excipient name to citric acid anhydrous in the  grape flavour

Updated on 17 November 2015

Reasons for updating

  • Change of inactive ingredient
  • Change to date of revision

Updated on 16 October 2015

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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

PRAC recommendation applicable to tadalafil and all other authorised phosphodiesterase type 5 (PDE5) inhibitors with regards to the need to include a contraindication in the Product information of all authorised PDE5 inhibitors in view of the identified safety issue of the concomitant administration of Adempas (riociguat) and PDE5 inhibitors.

Updates have been made to the  SmPC sections 4.3 and 4.5, and section 2 of the PIL in line with the PRAC recommendation. In addition the SmPC & PIL have been aligned to the EU QRD 9.1 template, and spelling of calcium sulphate updated to calcium sulfate in Revatio tablets spc section 6.6 and PIL. Other minor editorial/formatting revisions have also been made

Updated on 12 October 2015

Reasons for updating

  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision

Updated on 07 July 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 29 October 2014

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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows. Section 4.5 has been revised to update the numerical results for bosentan exposure change based on the final population pharmacokinetic analysis for study A1481243

Updated on 27 October 2014

Reasons for updating

  • Change to side-effects

Updated on 02 October 2014

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 10 September 2014

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 Section 4.8 has been updated to change the ADR reporting details from the IMB to HPRA.

Updated on 04 September 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details

Updated on 02 July 2014

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)

Free text change information supplied by the pharmaceutical company

Update to sections 4.4 & 4.5

Updated on 30 June 2014

Reasons for updating

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

Updated on 30 January 2014

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 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to sections 4.2, 4.4, 4.5 and 5.1

Updated on 24 January 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 06 January 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

tes to Sections 2, 4.8, 5.1, 6.5

Updated on 24 December 2013

Reasons for updating

  • Change to side-effects

Updated on 25 October 2013

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 24 October 2013

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

Update to SPC section 4.8

Updated on 02 September 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to sections 2, 4.1-4.6, 4.8, 5.1, 5.2, 6.4, 6.5, 6.6, 9 & 10

Updated on 28 August 2013

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Improved electronic presentation

Updated on 25 April 2013

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The revision date on the SPC has been updated from Jan2013 to December 2012, to reflect CHMP opinion date

Updated on 23 April 2013

Reasons for updating

  • Change to date of revision

Updated on 28 January 2013

Reasons for updating

  • 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

Update section 4.8 to include the adverse events  haematuria, penile haemorrhage, haematospermia.

Updated on 21 January 2013

Reasons for updating

  • Change to side-effects

Updated on 26 September 2012

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

None provided

Updated on 13 September 2012

Reasons for updating

  • New PIL for new product