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Taxotere (docetaxel) – Conditions or restrictions regarding supply and use - L01CD02

Updated on site: 10-Oct-2017

Medication nameTaxotere
ATC CodeL01CD02
Substancedocetaxel
ManufacturerAventis Pharma S.A.

A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Sanofi-Aventis Deutschland GmbH Industriepark Höchst

65926 Frankfurt am Main Germany

Sanofi-Aventis Zrt.

(Harbor Park) 1, Campona utca Budapest 1225

Hungary

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORIZATION

Periodic Safety Update Reports

The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

Not applicable

Obligation to conduct post-authorisation measures

Not applicable

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