Pelmeg 6 mg solution for injection in pre-filled syringe *

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 20 October 2021

File name

spc_1634733379.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

Shelf life reduced from 36 months to 2 years.

Updated on 16 July 2021

File name

pil_1626434427.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Addition of warnings in relation to myelodysplastic sydrome and acute myeloid leukaemia in patients with cancer.

Addition of myelodysplastic sydrome and acute myeloid leukaemia as possible side effects.

Updated on 16 July 2021

File name

spc_1626434299.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Section 4.4 - Addition of section on myelodysplastic sydrome and acute myeloid leukaemia.

Section 4.8 - Update to table to include myelodysplastic sydrome and acute myeloid leukaemia. Amendment to wording on sickle cell crisis and Sweet's syndrome for clarity. Addition of statement on myelodysplastic sydrome and acute myeloid leukaemia.

Updated on 05 November 2020

File name

spc_1604586560.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

Section 6.3 - Increase shelf life from 2 years to 36 months.

Section 7 - Change in MAH from Mundipharma Biologics to Mundipharma Corporation (Ireland).

Updated on 05 November 2020

File name

pil_1604586513.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Change in MAH from Mundipharma Biologics to Mundipharma Corporation (Ireland).

Change to address of manufacturer.

Updated on 25 November 2019

File name

spc_1574703506.pdf

Reasons for updating

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

Addition of Stevens-Johnson syndrome to section 4.4 and section 4.8.

Updated on 25 November 2019

File name

pil_1574703440.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Addition of Stevens-Johnson syndrome to section 2 'Warnings and precautions' and section 4 'Possible side effects'.

Updated on 06 September 2019

File name

spc_1567789242.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Free text change information supplied by the pharmaceutical company

Change of marketing authorisation holder and addition of date of first authorisation.

Updated on 06 September 2019

File name

pil_1567789174.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 05 February 2019

File name

IE pelmeg PIL drafted Feb 2019_1549373806.pdf

Reasons for updating

  • Addition of Black Inverted Triangle

Updated on 04 February 2019

File name

IE pelmeg PIL drafted Feb 2019_1549036278.pdf

Reasons for updating

  • New PIL for new product

Updated on 01 February 2019

File name

IE pelmeg SmPC 20 Nov 2018_1549036166.pdf

Reasons for updating

  • New SPC for new product

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