FRAGMIN

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

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 about Dalteparin

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

ATC code	Group title	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)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 522717100058818, 522717100058918, 522717100059018, 522717100059118, 522717100059218, 522717100059318, 522717100059418
Country: CA	Health Products and Food Branch	Identifier(s): 02132621, 02132648, 02132664, 02231171, 02352648, 02352656, 02352664, 02352672, 02352680, 02430789, 02494582
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 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
Country: EE	Ravimiamet	Identifier(s): 1003914, 1003969, 1012587, 1012598
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 58536, 58537, 61523, 62155, 62156, 62157, 62158, 62567
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 001004, 001029, 399733, 420117, 420356, 420471, 420497, 447052, 447110, 447136, 447151
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 37239, 38391, 38408, 39677, 39684, 39687, 39690, 39696, 39704, 39707, 48643
Country: HR	Agencija za lijekove i medicinske proizvode	Identifier(s): HR-H-109005464, HR-H-301773112, HR-H-395709650, HR-H-444888961, HR-H-485032160, HR-H-487948799, HR-H-875155534
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 4370, 4371, 6195, 6196
Country: JP	医薬品医療機器総合機構	Identifier(s): 3334403A2160
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1006238, 1006239, 1010456, 1010457, 1010458, 1010459, 1010460, 1015738, 1070229, 1070230, 1070231
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 110M93
Country: NL	Z-Index G-Standaard	Identifier(s): 13872117, 13872125, 13872133, 14074028, 14161486, 14161494, 14161524, 14161532
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 29777, 29785, 29793, 47309, 49174, 49182, 49204, 49212
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 4403, 4406, 8508
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100081969, 100081975, 100109998, 100110004, 100110010, 100110027, 100201899
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64848001, W64848002, W64849001, W64849002, W64850001, W64850002, W64852001, W64852002, W64853001, W64853002, W64854001, W64854002, W64855001, W64855002, W64856001
Country: SG	Health Sciences Authority	Identifier(s): 05240P, 05249P, 05250P, 05251P, 08056P, 09399P
Country: US	FDA, National Drug Code	Identifier(s): 0069-0195, 0069-0196, 0069-0206, 0069-0217, 0069-0220, 0069-0223, 0069-0228, 0069-0232
Country: ZA	Health Products Regulatory Authority	Identifier(s): X/8.2/87, X/8.2/88, X/8.2/89