AusPAR Attachment 2: Extract from the Clinical Evaluation ...
The drug product is an aqueous solution of fentanyl citrate, buffered to pH 6.6 with phosphate buffer. It is available in three strengths: 0.5, 1.0 and 2.0 mg/mL. Each strength is proposed for registration as a single dose spray or as a multi-dose spray. ................
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