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Certificates of Suitability for the active substances Oxytetracycline dihydrate and Oxytetracycline hydrochloride have been withdrawn

The following Certificates of Suitability (CEPs) have been withdrawn at the request of the manufacturer.

  • CEP 2004-177-Rev 00/ Oxytetracycline dihydrate
  • CEP 2008-165-Rev 00/ Oxytetracycline hydrochloride

The manufacturer concerned is:

Shandong Jinyang Pharmaceutical Co., Ltd.
No. 469 Chengli Street
Zichuan District, 255100 Zibo City, China

If the EDQM withdraws or suspends a CEP, the marketing authorisation holder must take the necessary measures to ensure that active substances from the concerned active substance manufacturer are not used, either permanently or for a defined period.

If any medicines on the market contain these active substances from the concerned active substance manufacturers, the marketing authorisation holder must report the product defect to the Danish Health and Medicines Authority at rapidalert@dkma.dk.

Please find additional information on EDQM's website.

Created 08 June 2012, Updated 13 June 2012