FRAGMIN

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Canada, Croatia, Estonia, Finland, Germany, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, UK.

Active ingredients

The drug FRAGMIN contains one active pharmaceutical ingredient (API):

1	Dalteparin UNII 12M44VTJ7B - DALTEPARIN SODIUM
	Dalteparin is an antithrombotic agent, which acts mainly through its ability to potentiate the inhibition of Factor Xa and thrombin by antithrombin. It has a relatively higher ability to potentiate Factor Xa inhibition than to prolong plasma clotting time (APTT).
	Read more about Dalteparin

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
FRAGMIN 10.000 IU Solution for injection	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)
FRAGMIN 2.500 IU Solution for injection	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)
FRAGMIN 12.500 IU Solution for injection	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)
FRAGMIN 100.000 IU Solution for injection	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)
FRAGMIN 7.500 IU Solution for injection	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)
FRAGMIN 5.000 IU Solution for injection	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
B01AB04	Dalteparin	B Blood and blood forming organs → B01 Antithrombotic agents → B01A Antithrombotic agents → B01AB Heparin group
Discover more medicines within B01AB04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	522717100058818, 522717100058918, 522717100059018, 522717100059118, 522717100059218, 522717100059318, 522717100059418
CA	Health Products and Food Branch	02132621, 02132648, 02132664, 02231171, 02352648, 02352656, 02352664, 02352672, 02352680, 02430789, 02494582
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	00225331, 00629525, 00629531, 00629548, 00657131, 00657177, 00657183, 00657214, 00657220, 00657237, 01546209, 01546215, 01546221, 01546244, 01546250, 01553468, 01553474, 01553480, 01975695, 01975726, 02042830, 02128603, 02561702, 02753502, 02753519, 02753531, 02753548, 02753695, 02753726, 02753732, 02753778, 03080347, 03285285, 04790430, 04790447, 05126740, 05126786, 05126792, 05746425, 05746431, 05746520, 05746566, 06729475, 06901661, 06901690, 07127927, 07314581, 07503939, 07503945, 07503974, 07504005, 07531870, 07531893, 07531918, 07531930, 07531953, 07535951, 07668296, 07767271, 07767288, 07767348, 07767414, 07767420, 08849427, 09000527, 09065811, 09197961, 09197978, 09197984, 09197990, 09198009, 09198015, 09198021, 09198647, 09214441, 09303558, 09303564, 09694599, 09714847, 09714853, 09714876, 09714882, 09714899, 09714907, 09714913, 09716102, 09723042, 09723059, 09723065, 09723102, 09723125, 09723131, 09726313, 09889765, 09889802, 09893620, 09893637, 09893643, 09893672, 09893689, 09893695, 09927738, 10072012, 10174913, 10174936, 10174942, 10174971, 10174988, 10174994, 10175002, 10274170, 10386667, 10532376, 10756940, 10756957, 10865959, 10866284, 11212739, 11212745, 11215086, 11215092, 11215100, 11215117, 11215123, 11294447, 11331036, 11367637, 11367643, 11367672, 11367689, 11367695, 11367726, 11367732, 11367749, 11367755, 12409711, 12409728, 12511562, 12511579, 13922913, 13922936, 13923404, 13923410, 13970361, 14292130, 14292147, 14350198, 15258135, 15258141, 16628522, 16628545, 16654413, 16931568, 16945317
EE	Ravimiamet	1003914, 1003969, 1012587, 1012598
ES	Centro de información online de medicamentos de la AEMPS	58536, 58537, 61523, 62155, 62156, 62157, 62158, 62567
FI	Lääkealan turvallisuus- ja kehittämiskeskus	001004, 001029, 399733, 420117, 420356, 420471, 420497, 447052, 447110, 447136, 447151
GB	Medicines & Healthcare Products Regulatory Agency	37239, 38391, 38408, 39677, 39684, 39687, 39690, 39696, 39704, 39707, 48643
HR	Agencija za lijekove i medicinske proizvode	HR-H-109005464, HR-H-301773112, HR-H-395709650, HR-H-444888961, HR-H-485032160, HR-H-487948799, HR-H-875155534
IL	מִשְׂרַד הַבְּרִיאוּת	4370, 4371, 6195, 6196
JP	医薬品医療機器総合機構	3334403A2160
LT	Valstybinė vaistų kontrolės tarnyba	1006238, 1006239, 1010456, 1010457, 1010458, 1010459, 1010460, 1015738, 1070229, 1070230, 1070231
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	110M93
NL	Z-Index G-Standaard	13872117, 13872125, 13872133, 14074028, 14161486, 14161494, 14161524, 14161532
NL	Z-Index G-Standaard, PRK	29777, 29785, 29793, 47309, 49174, 49182, 49204, 49212
NZ	Medicines and Medical Devices Safety Authority	4403, 4406, 8508
PL	Rejestru Produktów Leczniczych	100081969, 100081975, 100109998, 100110004, 100110010, 100110027, 100201899
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64848001, W64848002, W64849001, W64849002, W64850001, W64850002, W64852001, W64852002, W64853001, W64853002, W64854001, W64854002, W64855001, W64855002, W64856001
SG	Health Sciences Authority	05240P, 05249P, 05250P, 05251P, 08056P, 09399P
US	FDA, National Drug Code	0069-0195, 0069-0196, 0069-0206, 0069-0217, 0069-0220, 0069-0223, 0069-0228, 0069-0232
ZA	Health Products Regulatory Authority	X/8.2/87, X/8.2/88, X/8.2/89