For the Ministry of Health of the Slovak Republic (hereinafter "the Ministry'):
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director of the Division of Classification and Pricing, Mgr. Miriam Vulevová, MBA
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official of the Department of Classification and Pricing, Jana Ivanova
For Celgene s.r.o. (hereinafter "Celgene'):
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Dr. Ivan Ťurek, General Manger Slovakia & Czech Republic
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MUDr. Štefánia Navarčíková, Associate Director Drug Safety and Regulatory Affairs, Slovakia & Czech Republic
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Ingrid Tothová, Medical Director Slovakia & Czech Republic
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Tomáš Pastorek, Associate Director Sales, Marketing & Market Access
The meeting took place at the request of Celgene.
The meeting was opened by the Director of the Department of Classification and Pricing, Mgr. Miriam Vuleva, MBA.
Celgene:
Pharmaceutical company Celgene presented the importance at the meeting and current status A program to minimise the risk of thalidomide treatment lenalidomide and pomalidomide in Slovakia - Pregnancy Prevention Programme. In the second part of the meeting presented the planned requests for conditional inclusion in the list of categorised medicinal products in 2017 - Imnovid as continued conditional reimbursement for Abraxane. The border was also discussed the subject of the change of indication limit for Revlimid.
MZ SR:
The Ministry is familiar with the Risk Minimisation Programme, conditions the safe use of medicinal products and tasks of healthcare professionals; and the role of distributor - Phoenix within the RMinP program in Slovakia. Regarding evaluation of the conditional reimbursement of Abraxane as well as any application for inclusion of Imnovid in the list of categorised medicines will be the Ministry proceed in accordance with existing legislation on the basis of Law No 363/2011 Z. the scope and conditions for reimbursement of medicinal products, medical devices, and dietetic foods based on public health insurance and on change; and the addition of certain laws, as amended (hereinafter referred to as the An amendment to the Act is currently being prepared, which will in addition to deal with new models of how to pay the price of the medicine and possibly participation of pharmaceutical companies in continuing treatment in patients outside the the approved indicator restriction.
| She wrote: He checked for Celgene: It approved: Date: |
Ing. Jana Ivanova |