Transcription of ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
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ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I. SUMMARY OF PRODUCT CHARACTERISTICS . 1. This medicinal PRODUCT is subject to additional monitoring. This will allow quick identification of new safety information . Healthcare professionals are asked to report any suspected adverse reactions. See section for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT . Bemfola 75 mL solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION. Each mL of the solution contains 600 IU (equivalent to 44 micrograms) of follitropin alfa*. Each pre- filled pen delivers 75 IU (equivalent to micrograms) in mL. * recombinant human follicle stimulating hormone (r-hFSH) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 3. PHARMACEUTICAL FORM. Solution for injection in pre-filled pen (injection). Clear colourless solution.
2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
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