SD Dojavi
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Hrvatska agencija za lijekove i medicinske proizvode (HALMED) objavio je da se povlači dio serije lijeka Bretaris Genuair 322 mikrograma, prašak inhalata.

Tvrtka Berlin-Chemie Menarini Hrvatska d.o.o., predstavnik nositelja odobrenja za stavljanje u promet za lijek Bretaris Genuair 322 mikrograma, prašak inhalata (aklidinijev bromid), u suradnji s Agencijom za lijekove i medicinske proizvode provodi povlačenje dijela serije 17U predmetnog lijeka.

Povlačenje se provodi do razine ljekarni.

Navedeni postupak povlačenja provodi se zbog toga što je uočeno da uz lijek Bretaris Genuair (aklidinijev bromid) 322 mikrograma, prašak inhalata nije priložena odobrena uputa o lijeku na hrvatskom jeziku, nego su pakiranja dijela serije 17U opremljena za tržište Litve/Latvije/Estonije.

Lijek će po opremanju uputom na hrvatskom jeziku biti vraćen u promet.

Na tržištu u Republici Hrvatskoj u prometu su dostupne dovoljne količine serije 17U koja nije zahvaćena navedenom neispravnošću, stoga povlačenje dijela predmetne serije lijeka ne ugrožava redovitu opskrbu tržišta.

Iz HALMED-a podsjećaju da su zdravstveni radnici obvezni prijaviti HALMED-u svaku nuspojavu lijeka, kao i neispravnost u kakvoći lijeka.

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

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Hrvatska agencija za lijekove i medicinske proizvode (HALMED) objavio je da se povlači dio serije lijeka Bretaris Genuair 322 mikrograma, prašak inhalata.

Tvrtka Berlin-Chemie Menarini Hrvatska d.o.o., predstavnik nositelja odobrenja za stavljanje u promet za lijek Bretaris Genuair 322 mikrograma, prašak inhalata (aklidinijev bromid), u suradnji s Agencijom za lijekove i medicinske proizvode provodi povlačenje dijela serije 17U predmetnog lijeka.

Povlačenje se provodi do razine ljekarni.

Navedeni postupak povlačenja provodi se zbog toga što je uočeno da uz lijek Bretaris Genuair (aklidinijev bromid) 322 mikrograma, prašak inhalata nije priložena odobrena uputa o lijeku na hrvatskom jeziku, nego su pakiranja dijela serije 17U opremljena za tržište Litve/Latvije/Estonije.

Lijek će po opremanju uputom na hrvatskom jeziku biti vraćen u promet.

Na tržištu u Republici Hrvatskoj u prometu su dostupne dovoljne količine serije 17U koja nije zahvaćena navedenom neispravnošću, stoga povlačenje dijela predmetne serije lijeka ne ugrožava redovitu opskrbu tržišta.

Iz HALMED-a podsjećaju da su zdravstveni radnici obvezni prijaviti HALMED-u svaku nuspojavu lijeka, kao i neispravnost u kakvoći lijeka.

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

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Hrvatskaprašak

HALMED: S tržišta se povlači još jedan lijek, uočena je pogreška

Piše VIJESTI SD
6. srpnja 2023. - 22:28
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Hrvatska agencija za lijekove i medicinske proizvode (HALMED) objavio je da se povlači dio serije lijeka Bretaris Genuair 322 mikrograma, prašak inhalata.

Tvrtka Berlin-Chemie Menarini Hrvatska d.o.o., predstavnik nositelja odobrenja za stavljanje u promet za lijek Bretaris Genuair 322 mikrograma, prašak inhalata (aklidinijev bromid), u suradnji s Agencijom za lijekove i medicinske proizvode provodi povlačenje dijela serije 17U predmetnog lijeka.

Povlačenje se provodi do razine ljekarni.

Navedeni postupak povlačenja provodi se zbog toga što je uočeno da uz lijek Bretaris Genuair (aklidinijev bromid) 322 mikrograma, prašak inhalata nije priložena odobrena uputa o lijeku na hrvatskom jeziku, nego su pakiranja dijela serije 17U opremljena za tržište Litve/Latvije/Estonije.

Lijek će po opremanju uputom na hrvatskom jeziku biti vraćen u promet.

Na tržištu u Republici Hrvatskoj u prometu su dostupne dovoljne količine serije 17U koja nije zahvaćena navedenom neispravnošću, stoga povlačenje dijela predmetne serije lijeka ne ugrožava redovitu opskrbu tržišta.

Iz HALMED-a podsjećaju da su zdravstveni radnici obvezni prijaviti HALMED-u svaku nuspojavu lijeka, kao i neispravnost u kakvoći lijeka.

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

#POVLAČENJE LIJEKA#HALMED
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18. svibanj 2024 18:03