Nebido 1000 mg/4ml solution for injection
*Company:
Grunenthal Pharma Ltd.Status:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 15 December 2025
File name
ie_mt-pil-nebido-v4-clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
PIL updates following PRAC recommendation of a PSUSA/00010631/202412 outcome for testosterone, impacting PIL section 2 interactions with a group of medicines belonging to SGLT2 inhibitors (sodium–glucose co-transporter 2 inhibitors) and outlining the Risk of Pulmonary oily microembolism as a rare side effect.
Updated on 15 December 2025
File name
ie-spc-nebido-v2 clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SmPC and PIL updates following PRAC recommendation of a PSUSA/00010631/202412 outcome for testosterone, impacting SmPC section 4.5 interactions and 4.8 undesirable effects
Updated on 07 January 2025
File name
ie-pil-nebido-v3-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
File name
Nebido_admin guide_GRT Ireland_ v.2.2 Dec 2024_final.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Administrative details where updated.
Updated on 25 September 2024
File name
ie-pil-nebido-v2-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
File name
Nebido_admin guide_GRT Ireland_ v. Apr 2023.pdf
Reasons for updating
- Add New Doc
Updated on 02 May 2023
File name
ie-pil-nebido-v1-clean.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Change of Ownership from Bayer to Grunenthal Pharma Ltd.
Updated on 02 May 2023
File name
ie-spc-nebido-clean .pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Grunenthal Pharma Ltd.
Address:
4045 Kingswood Road, Citywest, DublinMedical Information E-mail:
medicalinformationie@grunenthal.comMedical Information Direct Line:
+44 (0)870 351 8960