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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