Labeling labeling artefact for Thymosilib in Singapore. Version 18.6. Language: en.

Artifact ID
LBL-047
Type
Labeling
Product
Market
Singapore
Version
18.6
Language
en
Status
Active
Last Reviewed
2023-08-31
Included Statements (3)
IDTypeSourceTextApproved
STMT-139DosingSmPC Section 4.1Patients should be advised not to drive or operate machinery if they experience …2023-05-10
STMT-140Special PopulationSmPC Section 5.1A paediatric investigation plan (PIP) has been agreed with the EMA.…2023-08-02
STMT-141PKSmPC Section 4.4Renal impairment does not significantly alter the pharmacokinetics of this compo…2024-02-19
Change History
2023-03-31 · Tomoko Ikeda
Posology revision
2024-05-14 · Nadia Petrova
New indication added
2023-06-18 · Tomoko Ikeda
Section 4.8 ADR update