SCHEDULING STATUS: S3 PROPRIETARY NAME AND DOSAGE FORM: LANTUS
®
solution for injection. COMPOSITION: Each ml of the solution for injection contains 3.64 mg of the active ingredient insulin glargine, corresponding
to 100 U human insulin, 2.7mg of the preservative metacresol and 0.0626mg of zinc chloride as stabiliser. 10ml vial contains 0.02mg polysorbate 20 as additional stabiliser. REGISTRATION NUMBER: 34/21.1/0248. NAME AND
BUSINESS ADDRESS OF THE APPLICANT: sanofi-aventis south africa (pty) ltd, 2 Bond Street, Midrand, 1685. Tel: 011 256 3700. Reg. No. 1996/10381/07.