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Trosyl 283mg/ml Nail Solution

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Pharmacy Only: Prescription
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Updated on 16 October 2024

File name

Reg SPC TY 9_0 IE-clean.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 16 October 2024

File name

Reg PIL TY 12_0 IE-clean.pdf

Reasons for updating

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

Updated on 14 February 2023

File name

Reg SPC TY 8_1 IE clean.pdf

Reasons for updating

  • Document format updated

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

Updated on 02 August 2018

File name

Reg PIL TY 11_1 IE clean.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 02 August 2018

File name

Reg SPC TY 8_1 IE clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Free text change information supplied by the pharmaceutical company

The SmPC has been updated as follows:

* Section 7 – changed from Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently

 

* Section 8 updated with the HPRA newly appointed Marketing Authorisation number.

Updated on 09 June 2015

Reasons for updating

  • New SPC for new product

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

Updated on 09 June 2015

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: To update section 4.8, Reporting of side effects, with the new name for the Irish health authority - HPRA

Updated on 04 June 2015

File name

PIL_10246_859.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 June 2015

Reasons for updating

  • Change to side-effects

Updated on 09 October 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Updated SPC in line with Core safety profile and QRD template with changes to sections 2, 4.1, 4.2, 4.3, 4.6, 4.7, 4.8, 4.9, 5.2, 6.5, 6.6, 9 &10

Updated on 02 October 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 14 June 2010

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

Section 6.4: Replace cap securely after use

Updated on 14 June 2010

Reasons for updating

  • Change to storage instructions

Updated on 21 August 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 06 July 2009

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



SmPC update to section 4.8 (Undesirable effects) to bring in line with the MedDRA organ classification and the frequency of undesirable effects

Updated on 24 April 2007

Reasons for updating

  • Change of manufacturer

Updated on 12 August 2005

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • 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 be renewed (B)

Updated on 12 August 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 23 June 2003

Reasons for updating

  • New SPC for medicines.ie

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

Pfizer Healthcare Ireland Unlimited Company

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