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Intended for UK patients and members of the public

Glimepiride 3mg Tablets

Glimepiride 3mg Tablets

PL Number:
20075/0089
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • Update section  4.2, 4.3, 4.6, 4.8, 4.9, and 5.1 of SmPC and section 1, 2, 3 and 4 of PIL information in line with the information of Reference product (AMARYL 1 mg, 2 mg, 3 mg, 4 mg.

    • Type IA (B.II.b.2.a) To add Labanalysis Life Science S.r.l. Via Europa 5, Casanova Lonati, 27041, Italy as an alternative site responsible for batch control/testing of the finished product.

    • Type IAIN (B.II.b.1.a): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for secondary packaging of the finished product.

    • Type IAIN (B.II.b.2.C.2): To add Accord Healthcare single member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.

      Consequently, the PIL is updated.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

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