The SPC has been updated as follows:

4.2   Posology and method of administration – following statement added to posology:

For patients who have received at least 24 weeks of treatment at the every two week schedule and have maintained the response, the dose interval should transition to an every four week schedule.

Table 1 and 5 updated:

With elranatamab dosing regimen to add every four-week dosing schedule after at least 24 weeks of every two-week dosing and to update the recommendations for restarting therapy following dose delay, based on the end of study results from Study C1071003. RMP updated accordingly.

Addition of a Q4W (SC) dosing regimen based on follow-up efficacy from the MagnetisMM-3 study.

4.8   Undesirable effects

Safety profile updated with data from end of study results from Study C1071003

4.9 Overdose

Section updated to minimal experience of overdose in clinical studies rather than no experience.

5.1 Pharmacodynamic properties

Inclusion of ATC code: L01FX32

Inclusion of end of study results from Study C1071003. The results provide information to fulfill the MM-3 specific obligation by providing long-term clinical efficacy and safety data.

5.2   Pharmacokinetic properties

Inclusion of end of study results from Study C1071003. The results provide information to fulfill the MM-3 specific obligation by providing long-term clinical efficacy and safety data.

6.3 Shelf life – section updated with the following wording:

After opening

Chemical and physical in-use stability after opening the vial, including storage in prepared syringes, has been demonstrated for 7 days at 2 °C to 8 °C and 24 hours at up to 30 °C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless preparation has taken place in controlled and validated aseptic conditions.

6.6 Special precautions for disposal and other handling – section updated to remove the below statement:

Once punctured, the vial and dosing syringe should be used immediately. If the prepared dosing syringe is not used immediately, store syringe between 2 °C to 30 °C for a maximum of 24 hours.