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Capecitabine SUN (capecitabine) – Conditions or restrictions regarding supply and use - L01BC06

Updated on site: 05-Oct-2017

Medication nameCapecitabine SUN
ATC CodeL01BC06
Substancecapecitabine
ManufacturerSun Pharmaceutical Industries Europe B.V.

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

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

 

AUTHORISATION

 

authorised

 

 

 

Periodic safety update reports

longer

 

 

 

 

At the time of granting the marketing authorisation, the submission of periodic safety update reports is not required for this medicinal product. However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) providednof r under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS

product WITH REGARD TO THE SAFE AND

EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk ManagementMedicinalPlan (RMP)

Not applicable.

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