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CPMP OPINION CPMP14795
PROPOSED LABELLING AND USER PACKAGE LEAFLET
adequate follicular development agonist ampoule Annex antibodies application assisted reproductive technologies Bari Blasio contraindicated Council Regulation CPMP opinion cysts development is achieved diluent diluent ampoule disodium hydrogen phosphate dose dossier EMEA final follicular maturation follicle stimulating hormone follitropin alpha 75 gamete intra-fallopian transfer gonadotrophin hFSH induce final follicular injection 3 ml intra-fallopian transfer GIFT IU-powder for injection lyophilisate Lyophilized MARKETING AUTHORIZATION HOLDER MEDICINAL PRODUCT GONAL METRODIN 150 Modugno needle OHSS ovarian disease ovarian hyperstimulation syndrome ovarian response ovulation PHARMACEUTICAL FORM pharmacodynamic pharmacological polycystic ovarian disease powder for injection pregnancy and lactation Proposed labelling r-hFSH and u-hFSH rapporteur reactions reconstitution route of administration Serono Laboratories UK Serono Pharma SpA sodium dihydrogen phosphate Special warnings study GF submitted summary of product superovulation syringe therapy tion toxicity studies transfer ZIFT treatment with GONAL urinary user package leaflet vitro fertilization vivo water for injection zygote intra-fallopian transfer