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Belupo hitno povlači seriju svog lijeka zbog sumnje u neispravnost u kakvoći, izvijestila je u ponedjeljak Agencija za lijekove.

Riječ je o tabletama Arvind 25 mg koje sadrže djelatnu tvar lamotrigin. A lamotrigin pripada skupini lijekova koji se nazivaju antiepileptici i njime se liječe epilepsija i bipolarni poremećaj.

"Belupo, nositelj odobrenja za lijek Arvind 25 mg tablete, u suradnji s Agencijom za lijekove provodi povlačenje serije 20924092 lijeka Arvind 25 mg tablete. Povlačenje se provodi do razine ljekarni.

Navedeni postupak povlačenja provodi se temeljem sumnje u neispravnost u kakvoći koja se odnosi na rezultat izvan granice specifikacije za parametar sadržaj djelatne tvari lamotrigin.

Na tržištu Republike Hrvatske u prometu su dostupne druge serije predmetnog lijeka koje nisu zahvaćene neispravnošću, kao i lijekovi s istom djelatnom tvari, istog farmaceutskog oblika i iste jačine drugih proizvođača, stoga povlačenje serije lijeka ne ugrožava redovitu opskrbu tržišta.

Pacijenti koji su razvili neku nuspojavu na lijek mogu to prijaviti izravno Agenciji uz preporuku da se za svaku nuspojavu koju zapaze obrate svom liječniku ili ljekarniku radi savjetovanja o načinu nastavka terapije", navode u Agenciji za lijekove.

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Belupo hitno povlači seriju svog lijeka zbog sumnje u neispravnost u kakvoći, izvijestila je u ponedjeljak Agencija za lijekove.

Riječ je o tabletama Arvind 25 mg koje sadrže djelatnu tvar lamotrigin. A lamotrigin pripada skupini lijekova koji se nazivaju antiepileptici i njime se liječe epilepsija i bipolarni poremećaj.

"Belupo, nositelj odobrenja za lijek Arvind 25 mg tablete, u suradnji s Agencijom za lijekove provodi povlačenje serije 20924092 lijeka Arvind 25 mg tablete. Povlačenje se provodi do razine ljekarni.

Navedeni postupak povlačenja provodi se temeljem sumnje u neispravnost u kakvoći koja se odnosi na rezultat izvan granice specifikacije za parametar sadržaj djelatne tvari lamotrigin.

Na tržištu Republike Hrvatske u prometu su dostupne druge serije predmetnog lijeka koje nisu zahvaćene neispravnošću, kao i lijekovi s istom djelatnom tvari, istog farmaceutskog oblika i iste jačine drugih proizvođača, stoga povlačenje serije lijeka ne ugrožava redovitu opskrbu tržišta.

Pacijenti koji su razvili neku nuspojavu na lijek mogu to prijaviti izravno Agenciji uz preporuku da se za svaku nuspojavu koju zapaze obrate svom liječniku ili ljekarniku radi savjetovanja o načinu nastavka terapije", navode u Agenciji za lijekove.

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StoryEditorOCM
Hrvatska i svijetVAŽNA OBAVIJEST

Iz svih ljekarni u Hrvatskoj se hitno povlači ovaj lijek: ‘Sumnjamo u nepravilnost! Ako imate nuspojave, odmah javite‘

Piše dv
23. siječnja 2024. - 12:37
&lt;p&gt;Ilustracija&lt;/p&gt;
IlustracijaRanko Suvar/Cropix/Cropix

Belupo hitno povlači seriju svog lijeka zbog sumnje u neispravnost u kakvoći, izvijestila je u ponedjeljak Agencija za lijekove.

Riječ je o tabletama Arvind 25 mg koje sadrže djelatnu tvar lamotrigin. A lamotrigin pripada skupini lijekova koji se nazivaju antiepileptici i njime se liječe epilepsija i bipolarni poremećaj.

"Belupo, nositelj odobrenja za lijek Arvind 25 mg tablete, u suradnji s Agencijom za lijekove provodi povlačenje serije 20924092 lijeka Arvind 25 mg tablete. Povlačenje se provodi do razine ljekarni.

Navedeni postupak povlačenja provodi se temeljem sumnje u neispravnost u kakvoći koja se odnosi na rezultat izvan granice specifikacije za parametar sadržaj djelatne tvari lamotrigin.

Na tržištu Republike Hrvatske u prometu su dostupne druge serije predmetnog lijeka koje nisu zahvaćene neispravnošću, kao i lijekovi s istom djelatnom tvari, istog farmaceutskog oblika i iste jačine drugih proizvođača, stoga povlačenje serije lijeka ne ugrožava redovitu opskrbu tržišta.

Pacijenti koji su razvili neku nuspojavu na lijek mogu to prijaviti izravno Agenciji uz preporuku da se za svaku nuspojavu koju zapaze obrate svom liječniku ili ljekarniku radi savjetovanja o načinu nastavka terapije", navode u Agenciji za lijekove.

#LIJEKOVI# AGENCIJA ZA LIJEKOVE#BELUPO
11. svibanj 2024 08:27