- A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
- B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
- C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
- D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer(s) of the biological active substance(s)
6000 Thompson Road
East Syracuse, New York 13057
Samsung Biologics Co. Ltd
300, Songdo Bio Way (Daero)
Name and address of the manufacturer(s) responsible for batch release
Contrada Fontana del Ceraso
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
•Periodic Safety Update Reports
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
•Risk Management Plan (RMP)
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
An updated RMP should be submitted:
•At the request of the European Medicines Agency;
•Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
•Additional risk minimisation measures
The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe YERVOY are provided with the following:
- Sustiva - Bristol-Myers Squibb Pharma EEIG
- Nulojix - Bristol-Myers Squibb Pharma EEIG
- Daklinza - Bristol-Myers Squibb Pharma EEIG
- Reyataz - Bristol-Myers Squibb Pharma EEIG
- Irbesartan hydrochlorothiazide bms - Bristol-Myers Squibb Pharma EEIG
- Nivolumab bms - Bristol-Myers Squibb Pharma EEIG
Prescription drugs listed. Manufacturer: "Bristol-Myers Squibb Pharma EEIG"
•Healthcare Professional FAQ Brochure
•Patient Information Brochures including Alert Cards
Key elements of the Healthcare Professional FAQ Brochure (Q&A format):
•Brief introduction to ipilimumab (indication and the purpose of this tool).
•List of important
o Inflammation of the gastrointestinal tract, such as colitis, which can lead to bowel perforation
o Inflammation of the liver, such as hepatitis, which can lead to liver failure
o Inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis) o Inflammation of the nerves that can lead to neuropathy
o Inflammation of the endocrine system. including the adrenal, pituitary, or thyroid glands o Inflammation of the eyes
o Other related irARs (e.g. pneumonitis, glomerulonephritis,
•Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and require early intervention, as outlined in the guidelines for the management of
•Importance of evaluating liver function tests (LFTs), TSH and signs/symptoms of irARs before each treatment.
•Reminder to distribute the Patient Information Brochure, and to educate patients/caregivers about symptoms of irARs and of the need to report them immediately to the physician.
Key elements for the Patient Information Brochure and Alert Card:
•Brief introduction to ipilimumab indication and the purpose of this tool.
•Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and need to be addressed immediately
•Request to inform the physician of all medical conditions before treatment.
•Description of the main symptoms of irARs and the importance of notifying their treating physician immediately if symptoms occur, persist or worsen.
o Gastrointestinal: diarrhea, bloody stool, abdominal pain, nausea, or vomiting o Liver: yellowing of your skin or whites of your eyes
o Skin: rash, blisters and/or peeling, mouth sores o Eye: blurred vision, vision changes, eye pain,
o General: fever, headache, feeling tired, dizziness or fainting, dark urine, bleeding, weakness, numbness of legs, arms, or faces, changes in behavior, such as less sex drive, being irritable or forgetful
•The importance of not attempting to
•Placeholder including the weblink of the Package Leaflet on the EMA website
•The importance of carrying the detachable
The Marketing Authorisation Holder shall agree the format and content of the above material with the National Competent Authority prior to launch in the Member State.
Obligation to conduct
The MAH shall complete, within the stated timeframe, the below measures:
The Marketing Authorisation Holder shall perform a randomized
Final study report:
comparison study of 3 mg/kg versus 10 mg/kg evaluating efficacy
and safety in advanced melanoma with a survival endpoint, based