Emergency Access to Remescor Outside of Clinical Trials
Enrollment in clinical trials is the primary way to access Remescor to generate critical data that inform the appropriate use of this investigational medicine. Emergency treatment requests are considered only when enrollment in a clinical trial is not a feasible option. PrimeCell is currently in the process of transitioning the provision of emergency access to Remescor for individual compassionate use requests. Primecell submited pharmaceutical documentation to SUKL 24. 3. 2020 to consider safety and efficacy of Remescor. An expanded access programs shall be developed based on evaluation of compassionate use for severely ill participating patients. These program is currently under rapid development in conjunction with national regulatory authorities.
- letter of NATIC to Ministerstvo zdravotnictví ČR a Ústřední krizový štáb
- Srovnání Remdesivir vs Remescor
1. § 49a Žádost o nemocniční výjimku pro léčivé přípravky pro moderní terapie; (https://www.zakonyprolidi.cz/cs/2007-378)
2. § 8 odst. 3 písm. b) bod 2 zákona o léčivech; (https://www.zakonyprolidi.cz/cs/2007-378)
