A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Hospira UK Limited
Hospira Enterprises B.V.
- Nivestim - Hospira UK Ltd
Prescription drugs listed. Manufacturer: "Hospira UK Ltd "
1316 BN, Almere
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
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
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