- A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER 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 OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer of the biological active substance
Name and address of the manufacturer responsible for batch release
Roche Pharma AG
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
•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 web- portal.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
•Risk Management Plan (RMP)
- Bondenza (ibandronic acid roche) - Roche Registration Ltd.
- Cotellic - Roche Registration Ltd
- Zelboraf - Roche Registration Ltd
- Gazyvaro - Roche Registration Ltd
- Erivedge - Roche Registration Ltd
Prescription drugs listed. Manufacturer: "Roche Registration Ltd"
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 MAH shall agree the content and format of the Kadcyla educational material and a communication plan with the National Competent Authority in the Member State before Kadcyla is launched in each Member State.
The MAH shall ensure that in parallel to the launch of Kadcyla, all health care professionals who may prescribe, dispense or administer Kadcyla and/or Herceptin are provided with a health care professional (HCP) educational pack. This HCP educational pack shall consist of the following:
•Health care professional information
The HCP information shall contain the following key messages:
1.Kadcyla and Herceptin are two very different products with different active substances never to be used interchangeably. Kadcyla is NOT a generic version of Herceptin and has different properties, indications and dose.
2.Kadcyla is an
3.Do not substitute or combine Kadcyla with or for Herceptin
4.Do not administer Kadcyla in combination with chemotherapy
5.Do not administer Kadcyla at doses greater than 3.6 mg/kg once every 3 weeks
6.If a prescription for Kadcyla is written electronically, it is important to ensure that the medication prescribed is trastuzumab emtansine and not trastuzumab.
7.Both the invented name Kadcyla and its full
8.In order to prevent medication errors it is important to review the Summary of Product Characteristics and to check the outer carton and vial labels to ensure that the medicinal product being prepared and administered is Kadcyla and not Herceptin.
9.Description of the key differences between Kadcyla and Herceptin in relation to indication, dose, administration and packaging differences.