PIL - Gemcitabine 100 mg/ml Concentrate for solution for infusion: Change history

Description of update: The following change(s) has been notified:

Type IA

5 x B.III.1 Submission of a new or updated Ph. Eur. certificate of suitability or deletion of Ph. Eur. Certificate of suitability

1. European Pharmacopoeial Certificate of Suitability to the relevant Ph. Eur. Monograph.

2. Updated certificate from an already approved manufacturer

• Update the Ph. Eur. Certificate of Suitability for Gemcitabine hydrochloride from the already approved manufacturer:

• HETERO LABS LIMITED updated from R1-CEP 2009-208-Rev 01 to R1-CEP 2009-208-Rev 02

• INTAS PHARMACEUTICALS LIMITED updated from R1-CEP 2009-089 - Rev 01 to R1-CEP 2009-089 - Rev 02

• SHILPA PHARMA LIFESCIENCES LIMITED updated from R1-CEP 2006-222 - Rev 00 to R1-CEP 2006-222 - Rev 01 

• SCINOPHARM TAIWAN, LTD. updated from R1-CEP 2006-272 - Rev 04 to R1-CEP 2006-272 - Rev 05

• SCINOPHARM TAIWAN, LTD. updated from R1-CEP 2006-272 - Rev 05 to R1-CEP 2006-272 - Rev 06

 A.7 Deletion of manufacturing sites for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place, or supplier of a starting material, reagent or excipient (when mentioned in the dossier)

• Delete Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, Nizozemska as Batch release site and batch importation function remains as approved.

PIL sections updated: Section 6 only.

Initial upload