v3 · current
C. Laurent (Regulatory Affairs Lead) · 08 Apr 2024 · 2c11fada4f51…
Confirmed unchanged at PSUR 1 review
High-density polyethylene (HDPE) bottle with child-resistant polypropylene closure and desiccant. Pack sizes: 30 film-coated tablets and 90 film-coated tablets.
v2
Dr. S. Patel (CMC Regulatory) · 12 Sept 2023 · 2c11fada4f51…
Added 90-tablet pack size approved via Type IA variation
High-density polyethylene (HDPE) bottle with child-resistant polypropylene closure and desiccant. Pack sizes: 30 film-coated tablets and 90 film-coated tablets.
v1
Dr. A. Müller (MAH Medical Affairs) · 15 Mar 2023 · 030c2909fd5e…
Initial submission
High-density polyethylene (HDPE) bottle with child-resistant polypropylene closure and desiccant. Pack sizes: 30 film-coated tablets.