Ikigo cy’Igihugu gishinzwe kugenzura Ibiribwa n’Imiti (Rwanda FDA), cyahagaritse ikwirakwizwa n’ikoreshwa ry’umuti wa Amoxicillin 125 gm/5ml Oral Suspension (SPAMOX), ufite numero wakoreweho ya X0928.
Mu itangazo ryashyizweho umukono n’Umuyobozi Mukuru wa Rwanda FDA, Dr Emile Bienvenu, avuga ko iri tangazo rireba abinjiza imiti mu gihugu, abaranguza imiti bose, abacuruza imiti bose, abaganga bose, amavuriro ya Leta n’ayigenga n’abakoresha imiti bose.
Guhagarika uyu muti Rwanda FDA yashingiye ku itegeko No 003/2018 ryo ku wa 09/02/2018 rishyiraho Ikigo cy’Igihugu Gishinzwe kugenzura Ibiribwa n’Imiti (Rwanda FDA), cyane cyane mu ngingo yaryo ya 8, igika cya 2 n’icya 13.
Hashingiwe kandi kuri raporo zakiriwe na Rwanda FDA zavuye mu mavuriro, zigaragaza ko numero X0928 y’umuti wa Amoxicillin 125mg/5ml Oral Suspension (SPAMOX), ikekwa ko itujuje ubuziranenge.
Hashingiwe nanone ku busesenguzi bwakozwe na Rwanda FDA, no ku bipimo by’ubuziranenge bya Laboratwari, byagaragaje ko umuti wa Amoxicillin 125mg/5ml Oral Suspension, ufite nimero wakoreweho ya X0928 utujuje ubuziranenge, Rwanda FDA ihagaritse ikwirakwizwa n’ikoreshwa ry’uwo muti ufite ibiwuranga bikurikira : Izina ry’umuti ni Amoxicillin 125mg /5ml Oral Suspension (Spamox), Nimero uwo muti wakoreweho ni X0928, Igihe wakorewe ni 05/2020, Igihe uzarangirira ni 04/2023, uruganda rwawukoze ni SPARSH BIO_Tech PVT Ltd/India.
Rwanda FDA irasaba abo bireba bose guhagarika gukwirakwiza, kugurisha, no gukoresha umuti wavuzwe haruguru ufite numero wakoreweho ya X0928, bakawusubiza aho bawuranguriye.
Abinjije uyu muti mu gihugu barasabwa gutanga Raporo kuri Rwanda FDA igizwe n’imibare y’ingano y’uwo baranguye, uwo bagurishije, uwagaruwe ndetse n’ingano yose bazaba bafite mu gihe cy’iminsi cumi n’itanu (15) uhereye ku itariki y’iri hagarikwa.
Kubindi bisobanuro mwahamagara kuri numero ya Terefone 0789193529, cyangwa bakohereza ubutumwa kuri email pv-sm@rwandafda.gov.rw
