Table 2.

Storage conditions for stability studies and approved shelf life in EU for etanercept DP presentations

Presentationa	Storage condition (no of batches)		Approved shelf-life in EU
	25°C±2°C	30°C±2°C	5°C±3°C	25°C±2°C
10 mg/vial Lyo DP23	To 24 months (3)	To 4 weeks (3)b	36 months	4 weeks
25 mg/vial Lyo DP12	To 24 months (5)	To 4 weeks (2)c	48 months	4 weeks
25 mg PFS DP24	To 12 months (7)	To 4 weeks (6)d	30 months	4 weeks
50 mg PFS DP25	To 12 months (7)	To 4 weeks (7)d	30 months	4 weeks
50 mg PFP DP26			30 months	4 weeks

Notes:

^aSince the 50 mg PFP encloses a single etanercept 50 mg DP solution for injection in PFS, and the PFP components do not have any contact with the DP contained in the PFS or with the needle that is preattached to the syringe, the analysis performed on etanercept 50 mg DP PFS is considered applicable to the 50 mg PFP presentation.

^bSamples were stored for 39 months at 5°C±3°C prior to storage at 30°C±2°C.

^cSamples were stored for 36 months at 5°C±3°C prior to storage at 30°C±2°C.

^dSamples were stored for 30 or 36 months at 5°C±3°C prior to storage at 30°C±2°C.

Abbreviations: EU, European Union; DP, drug product; Lyo, lyophilized powder; PFS, prefilled syringe; PFP prefilled pen.