A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer of the biological active substance
LG Life Sciences Ltd., Iksan Plant, 601
BioPartners GmbH, Kaiserpassage 11,
B. CONDITIONS OF THE MARKETING AUTHORISATION
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
THE MARKETING AUTHORISATION HOLDER
Medicinal product subject to restricted medical prescription (See Annex I: Summa y of Product Characteristics, section 4.2).
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
The MAH must ensure that the systemproductof pharmacovigilance, as presented in Module 1.8.1. of the
Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Risk Management Plan
potential risk. The R sk Management plan should be submitted by 9 May 2012.
The MAH shouldMedicinalsubmit updated Risk Management Plan reflecting: New neoplasm, Second neoplasm in childhood ca cer survivors and Intracranial aneurysm and Intracranial haemorrhage as
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.1 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
In addition, an updated RMP should be submitted
-When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
-Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
-At the request of the European Medicines Agency