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Topotecan Hospira (topotecan) – Conditions or restrictions regarding supply and use - L01XX17

Updated on site: 10-Oct-2017

Medication nameTopotecan Hospira
ATC CodeL01XX17
Substancetopotecan
ManufacturerHospira UK Ltd  

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Hospira UK Limited

Horizon

Honey Lane

Hurley

Maidenhead

SL6 6RJ

UK

Or

Hospira Enterprises B.V.

Randstad 22-11

1316 BN, Almere

The Netherlands

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 AUTHORISATION

Pharmacovigilance system

The MAH must ensure that the system of Pharmacovigilance, as presented in Module 1.8.1 of the Marketing Authorisation Application, is in place and functioning before and whilst the medicinal product is on the market.

Risk Management Plan

Not Applicable

PSURs

The PSUR submission schedule should follow the PSUR schedule for the reference medicinal product.

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

Not applicable

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