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Apr. 17 – Canada: Two Amendments to the Food and Drug Regulations

Nexreg Compliance

First, Regulations Amending the Food and Drug Regulations (1528 — Schedule F):

1. The reference to

Botulinum Toxin Type A

Antitoxine botulinique, Type A

in Part I of Schedule F to the Food and Drug Regulations… is replaced by the following:

Botulinum toxin Type A

Toxine botulinique, type A

2. Part I of Schedule F to the Regulations is amended by adding the following in alphabetical order:

Alglucosidase alfa

Alglucosidase alfa

Darunavir

Darunavir

Natalizumab

Natalizumab

Rasagiline and its salts

Rasagiline et ses sels

Sorafenib and its salts

Sorafénib et ses sels

Tigecycline

Tigécycline

Second, Regulations Amending the Food and Drug Regulations (1541 — Schedule F):

1. The reference to

Diclofenac and its salts

Diclofénac et ses sels

in Part I of Schedule F to the Food and Drug Regulations… is replaced by the following:

Diclofenac and its salts, except when sold as a single medicinal ingredient in a concentration equivalent to 1% or less diclofenac in preparations for topical use on the skin

Diclofénac et ses sels sauf s’ils sont vendus comme ingrédient médicinal unique en une concentration maximale de 1 % dans les préparations pour usage topique sur la peau

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