proposed amendment to the food and drug regulations project no. 1595 schedule f 5 pages available in english and french the purpose of this letter is to provide an opportunity for comment on the proposed addition of four medicinal ingredients to part i of schedule f to the food and drug regulations. description of the medicinal ingredients 1. dabigatran and its salts and derivatives is an anticoagulant blood thinner agent used to prevent the formation of blood clots in the veins of the legs or lungs in patients who have undergone elective total hi replacement or total knee replacement surgery. individualized instructions and direct supervision by a practitioner are required. the patient may also require treatment with other drugs and routine laboratory monitoring. dabigatran and its salts and derivatives may cause undesirable or severe side effects at normal therapeutic dosage levels. 2. nelarabine is used to treat specific types of cancer called t-cell acute lymphoblastic leukemia t-all and t-cell lymphoblastic lymphoma t-lbl in patients whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. nelarabine should be administered under the supervision of a practitioner experienced in the use of anti-cancer drugs. nelarabine may cause undesirable or severe side effects at normal therapeutic dosage levels. 3. nilotinib and its salts is used to treat a type of blood cancer called philadelphia chromosome positive chronic myeloid leukemia cml in adult patients resistant to or intolerant of at least one prior therapy. individualized instructions and direct supervision by a practitioner are required. the patient may also require routine laboratory monitoring. nilotinib and its salts may cause undesirable or severe side effects at normal therapeutic dosage levels. 4. rivaroxaban is an anticoagulant blood thinner agent used to prevent the formation of blood clots in the veins of patients who have undergone elective total hi replacement or total knee replacement surgery. individualized instructions and direct supervision by a practitioner are required. the patient may also require treatment with other drugs and routine laboratory monitoring. rivaroxaban may cause undesirable or severe side effects at normal therapeutic dosage levels. the degree of regulatory control afforded by schedule f prescription drug status coincides with the risk factors associated with each medicinal ingredient. oversight by a practitioner is necessary to ensure that appropriate risk benefit information is considered before the drug containing the medicinal ingredient is administered and that the drug therapy is properly monitored. schedule f is a list of medicinal ingredients the sale of which is controlled under sections c.01.041 to c.01.049 of the food and drug regulations. part i of schedule f lists ingredients that require a prescription for human use and for veterinary use. part ii of schedule f lists ingredients that require a prescription for human use but do not require a prescription for veterinary use if so labelled or if in a form unsuitable for human use.