DECISION
Issue: CU-10/JAN/2019
Approval of Temporary Individual Access to Early Access to the Medicinal Product
GLIOVAC (Haptenized and Radiated Allogeneic and Autologous Cancer Cells and Lysates), Solution for Injection-0.1-*10 6-7 (10 vials of 0.250 ml)
(Responsible Sponsor:
ERC BELGIUM)
Taking into account:
- The regulation of Ν. 1316/83, as modified and is valid
- The Ν.Δ. 96/73, as modified and is valid
- The ΚΥΑ ΔΥΓ3 (α)/Γ.Π. 32221/2013 (ΦΕΚ Β’ 1049/2013) concerning the harmonization of Greek legislation with the instruction 2001/83 as modifired
- The article 5 of No 2001/83/EK instruction
- The No ΔΥΓ3 (α)/Γ.Π.85037/2010 (ΦΕΚ Β 558/8-4-2011) Minister’s Decision concerning the Early Access to Medicines (Compassionate Use)
- The instruction of GVP Modules
- The No prot.: 11221/31-01-2019 Application of the Attending Doctor
- The of the Department of Products Evaluation
We approve Temporary Individual Access to Early Access to the Medicinal Product GLIOVAC (Haptenized and Radiated Allogeneic and Autologous Cancer Cells and Lysates), for the hospital “Athens Euroclinic”, with Responsible Doctor Chris Panopoulos, for the patient with initials MHT. MIX. (Male), age 53, that suffers from multifocal gliovlastoma.
Daily dosage/Route of Administration: 2×5 injection/28 days, Subcutaneous Injection,
Duration of Treatment: 3 (three) months
The abovementioned medicine
is provided FOR FREE by the company:
ERC Belgium.
The Responsible Doctors are obliged to:
- To practice den approved from the National Organization of Medicines the Medicine Risk Management Plan
- To maintain file with personal cards and the patients consent forms, anytime to the National Organization of Medicines disposal
- To inform the National Organization of Medicines for the progress of the treatment and also after its end to submit detailed report with its end results.
- To record all the side effects that notice during the treatment and to send them to the National Organization of Medicines (according to the current system of Pharmacovigilance) or to the Market Authorization Responsible.
CC: Scientific Council of Athens Euroclinic
Department Deputy Matron Maria Orphanos
Internal Distribution: Customs Clearance Control
For the original document in Greek please click on the
follow link.
