Clexane 10 000 IU (100 mg)/1 ml otopina za injekciju u napunjenoj štrcaljki

Name	Clexane 10 000 IU (100 mg)/1 ml otopina za injekciju u napunjenoj štrcaljki
Former Name	Clexane 10.000 IU anti-Xa/1,0 ml otopina za injekciju u napunjenoj štrcaljki; Clexane 10 000 IU (100 mg)/1 ml otopina za injekciju
Marketing Authorisation Number	HR-H-165030097
Active Substance	enoksaparinnatrij
Composition	jedna napunjena štrcaljka sadrži 10 000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 100 mg) u 1,0 ml vode za injekcije
Pharmaceutical Form	otopina za injekciju u napunjenoj štrcaljki
Manufacturer	Sanofi Winthrop Industrie, Maisons-Alfort, Francuska Sanofi Winthrop Industrie, Le Trait, Francuska Chinoin Pharmaceutical and Chemical Works Private Co. Ltd., Miskolc, Mađarska Sanofi-Aventis Private Co. Ltd, Budimpešta, Mađarska Sanofi-Aventis Deutschland GmbH, Frankfurt, Njemačka Sanofi-Aventis GmbH, Beč, Austrija
Marketing Authorisation Holder	Sanofi Winthrop Industrie, 82, avenue Raspail, Gentilly, Francuska
Marketing Authorisation Date	01.09.2023
MA Period of Validity	unlimited
Classification Number	UP/I-530-09/13-02/506
Registration Number	381-12-01/171-23-94
Prescription	Medicinal product subject to medical prescription
Type of prescription	Medicinal product subject to restricted medical prescription
Distribution	Supply through pharmacies (community)
Advertising to general public	not allowed
ATC Code	B01AB05
Marketing status	Marketed
Shortage status	No shortage
SmPC	download
PL	download
Public Assessment Report	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
2 napunjene štrcaljke s 1,0 ml otopine, u kutiji	HR-H-165030097-01	Never marketed	-
10 napunjenih štrcaljki s 1,0 ml otopine, u kutiji	HR-H-165030097-02	Marketed	No shortage
5 napunjenih štrcaljki s 1,0 ml otopine, u kutiji	HR-H-165030097-03	Never marketed	-
6 napunjenih štrcaljki s 1,0 ml otopine, u kutiji	HR-H-165030097-04	Never marketed	-
12 napunjenih štrcaljki s 1,0 ml otopine, u kutiji	HR-H-165030097-05	Never marketed	-
20 napunjenih štrcaljki s 1,0 ml otopine, u kutiji	HR-H-165030097-06	Never marketed	-
24 napunjene štrcaljke s 1,0 ml otopine, u kutiji	HR-H-165030097-07	Never marketed	-
30 napunjenih štrcaljki s 1,0 ml otopine, u kutiji	HR-H-165030097-08	Never marketed	-
50 napunjenih štrcaljki s 1,0 ml otopine, u kutiji	HR-H-165030097-09	Never marketed	-
100 napunjenih štrcaljki s 1,0 ml otopine, u kutiji	HR-H-165030097-10	Never marketed	-
2 napunjene štrcaljke sa sigurnosnim sustavom s 1,0 ml otopine, u kutiji	HR-H-165030097-11	Never marketed	-
5 napunjenih štrcaljki sa sigurnosnim sustavom s 1,0 ml otopine, u kutiji	HR-H-165030097-12	Never marketed	-
6 napunjenih štrcaljki sa sigurnosnim sustavom s 1,0 ml otopine, u kutiji	HR-H-165030097-13	Never marketed	-
10 napunjenih štrcaljki sa sigurnosnim sustavom s 1,0 ml otopine, u kutiji	HR-H-165030097-14	Never marketed	-
12 napunjenih štrcaljki sa sigurnosnim sustavom s 1,0 ml otopine, u kutiji	HR-H-165030097-15	Never marketed	-
20 napunjenih štrcaljki sa sigurnosnim sustavom s 1,0 ml otopine, u kutiji	HR-H-165030097-16	Never marketed	-
24 napunjene štrcaljke sa sigurnosnim sustavom s 1,0 ml otopine, u kutiji	HR-H-165030097-17	Never marketed	-
30 napunjenih štrcaljki sa sigurnosnim sustavom s 1,0 ml otopine, u kutiji	HR-H-165030097-18	Never marketed	-
50 napunjenih štrcaljki sa sigurnosnim sustavom s 1,0 ml otopine, u kutiji	HR-H-165030097-19	Never marketed	-
100 napunjenih štrcaljki sa sigurnosnim sustavom s 1,0 ml otopine, u kutiji	HR-H-165030097-20	Never marketed	-
30 (3 kutije s 10) napunjenih štrcaljki s 1,0 ml otopine, u kutiji	HR-H-165030097-21	Never marketed	-
90 (9 kutija s 10) napunjenih štrcaljki s 1,0 ml otopine, u kutiji	HR-H-165030097-22	Never marketed	-
30 (3 kutije s 10) napunjenih štrcaljki sa sigurnosnim sustavom s 1,0 ml otopine, u kutiji	HR-H-165030097-23	Never marketed	-
90 (9 kutija s 10) napunjenih štrcaljki sa sigurnosnim sustavom s 1,0 ml otopine, u kutiji	HR-H-165030097-24	Never marketed	-

Direct Healthcare Professional Communication

Name	Date	Download
Pismo zdravstvenim radnicima o ažuriranju izražavanja jačine doze, režima primjene kod duboke venske tromboze/plućne embolije i uporabe u bolesnika s teškim oštećenjem funkcije bubrega za lijek Clexane (enoksaparinnatrij)	28.04.2017	sanofi-aventis Croatia d.o.o.