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Rectogesic 4 mg/g Rectal Ointment

*
Pharmacy Only: Prescription

  • Company:

    Grünenthal Meds

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Glyceryl Trinitrate

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

Updated on 10 February 2023

File name

Rectogesic 4mg-g Rectal Ointment - PIL - Ireland clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Change to section 4 - Reporting of side effects - where to report a side effect; Date of revision from December 2018 to January 2023

Updated on 14 December 2018

File name

Rectogesic 4mg-g Rectal Ointment PIL IE - Clean (003).pdf

Reasons for updating

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

Updated on 14 December 2018

File name

Rectogesic 4mg-g Rectal Ointment SPC IE - Clean (003).pdf

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7- Marketing Authorisation Holder has been updated to Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132NP Hoofddorp Netherlands

Section 8- Marketing Authorisation Number has been updated to PA2288/001/003

Section 10- Date of (partial) revision of the text changed from May 2016 to Dec 2018

Updated on 01 November 2016

Reasons for updating

  • New SPC for new product

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

Updated on 01 November 2016

Reasons for updating

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

In section 7- Marketing Authorisation Holder Name change from ProStrakan to Kyowa Kirin$0In section 10- Date of (partial) revision of the text changed from June 2015 to May 2016$0

Updated on 28 October 2016

File name

PIL_16564_715.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 October 2016

Reasons for updating

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

Updated on 18 February 2016

Reasons for updating

  • New SPC for medicines.ie

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 21 December 2015

Reasons for updating

  • New PIL for medicines.ie