Rectogesic 4 mg/g Rectal Ointment *

  • Company:

    Kyowa Kirin International plc
  • Status:

    No Recent Update
  • Legal 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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 14 December 2018

File name

Rectogesic 4mg-g Rectal Ointment PIL IE - Clean (003)_1544780937.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)_1544780773.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

  • 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 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 28 October 2016

Reasons for updating

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

Updated on 28 October 2016

File name

PIL_16564_715.pdf

Reasons for updating

  • New PIL for new product

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