Pelmeg 6 mg solution for injection in pre-filled syringe
*Company:
Mundipharma Pharmaceuticals Limited - Formerly Napp LaboratoriesStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 20 October 2021
File name
spc.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.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.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.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.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.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.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.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.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 05 February 2019
File name
IE pelmeg PIL drafted Feb 2019.pdf
Reasons for updating
- Addition of Black Inverted Triangle
Updated on 04 February 2019
File name
IE pelmeg PIL drafted Feb 2019.pdf
Reasons for updating
- New PIL for new product
Updated on 01 February 2019
File name
IE pelmeg SmPC 20 Nov 2018.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)