PIL - Docetaxel Accord 20mg/1ml, 80mg/4ml, 160mg/8ml Concentrate for solution for infusion: Change history
View Patient Information Leaflet (PIL - Docetaxel Accord 20mg/1ml, 80mg/4ml, 160mg/8ml Concentrate for solution for infusion)
Last updated on this site: 04 Sep 2023
To update sections 4.4, 4.6, 5.2, 5.3 of the SmPC and section 2 of PIL for Docetaxel Accord 20 mg/ml Concentrate for Solution for Infusion in-line with the reference product (TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion; EU reference procedure number with outcome:
EMEA/H/C/000073/II/0141; MAH: Sanofi Mature IP, France). In addition editorial updates has been made in section 5.1 of SmPC in line with the reference product.
Last updated on this site: 04 Sep 2023
To update sections 4.4, 4.6, 5.2, 5.3 of the SmPC and section 2 of PIL for Docetaxel Accord 20 mg/ml Concentrate for Solution for Infusion in-line with the reference product (TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion; EU reference procedure number with outcome:
EMEA/H/C/000073/II/0141; MAH: Sanofi Mature IP, France). In addition editorial updates has been made in section 5.1 of SmPC in line with the reference product.
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Changes: (Updated: 04 Sep 2023)
To update sections 4.4, 4.6, 5.2, 5.3 of the SmPC and section 2 of PIL for Docetaxel Accord 20 mg/ml Concentrate for Solution for Infusion in-line with the reference product (TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion; EU reference procedure number with outcome:
EMEA/H/C/000073/II/0141; MAH: Sanofi Mature IP, France). In addition editorial updates has been made in section 5.1 of SmPC in line with the reference product.
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Changes: (Updated: 12 May 2023)
Description of update: To update section 4.4 with the ethanol warning for 4ml and 8ml of SPC and section 2 of PIL in-line with the information approved in the leaflet to correct the error in the calculation of equivalent quantity of Beer and wine for 4ml and 8ml.
PIL sections updated: 2, 6.
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Changes: (Updated: 20 Sep 2022)
Initial upload