Ngenla® 24 mg & 60 mg solution for injection in pre-filled pen
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
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 28 April 2025
File name
Adv SPC NL 6_0 IE clean.pdf
Reasons for updating
- 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
The SPC has been updated as follows: Section 10 EMA website link has been updated.
Updated on 25 April 2025
File name
Adv PIL NL 5_0 60mg IE clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 25 April 2025
File name
Adv PIL NL 5_0 24mg IE clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 24 April 2025
File name
Adv SPC NL 6_0 IE clean.pdf
Reasons for updating
- 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
The SPC has been updated as follows: Section 10 EMA website link has been updated.
Updated on 24 April 2025
File name
Adv PIL NL 5_0 60mg IE clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 24 April 2025
File name
Adv PIL NL 5_0 24mg IE clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 25 March 2024
File name
Adv SPC NL 5_0 IE clean.pdf
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 March 2024
File name
Adv PIL NL 4_0 60mg IE NI clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 25 March 2024
File name
Adv PIL NL 4_0 24mg IE NI clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 26 October 2023
File name
Adv SPC NL 4_0 IE clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 5.1 - Pharmacodynamic properties
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 October 2023
File name
Adv PIL NL 3_0 60mg IE NI clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 26 October 2023
File name
Adv PIL NL 3_0 24mg IE NI clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 26 October 2023
File name
Adv PIL NL 3_0 60mg IE NI clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 26 October 2023
File name
Adv PIL NL 3_0 24mg IE NI clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 13 December 2022
File name
AdvSPCNL30IEclean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 December 2022
File name
Adv PIL NL 2_0 60 mg IE NI clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 01 December 2022
File name
Adv PIL NL 2_0 24 mg IE NI clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 22 September 2022
File name
Adv PIL NL 1_0 24mg IE NI.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL for New Product
Updated on 22 September 2022
File name
Adv PIL NL 1_0 60mg IE NI.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL for New Product
Updated on 22 September 2022
File name
Adv SPC NL 2_0 IE.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New SPC for New Product
Pfizer Healthcare Ireland Unlimited Company
Address:
The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, IrelandTelephone:
+353 1 467 6500Fax:
+353 1 467 6501Website:
https://www.pfizermedicalinformation.ie/Medical Information Direct Line:
1 800 633 363