A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Roche Pharma AG
- Ebilfumin - oseltamivir
Prescription drugs listed. Substance: "Oseltamivir"
D- 79639 Grenzach
B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to medical prescription
- Zenapax - Roche Registration Ltd.
- Bondronat - Roche Registration Ltd.
- Viracept - Roche Registration Ltd.
- Bondenza (ibandronic acid roche) - Roche Registration Ltd.
- Cellcept - Roche Registration Ltd.
Prescription drugs listed. Manufacturer: "Roche Registration Ltd."
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
•Conditions or Restrictions with Regard to the Safe and Effective Use of the Medicinal Product
- Ebilfumin - J05AH02
Prescription drugs listed. ATC Code: "J05AH02"
The MAH shall ensure that at the launch of Tamiflu 6 mg/ml powder for oral suspension, all physicians who are expected to prescribe or use Tamiflu are provided with a Direct Healthcare Professional Communication letter, the text of which is appended to the CHMP assessment report. The MAH shall agree the communication plan for the DHPC letter with the National Competent Authority in the Member States where the letter will be distributed.
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.