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Interim Supply Key Information: Propylthiouracil (PTU) 50 mg tablets imported into Canada on an interim basis

This page provides patients with all key information relating to Halewood’s Propylthiouracil (PTU) 50 mg tablets that are being imported into Canada on an interim basis, in accordance with the COVID-19 Interim Order.

There is currently a shortage of propylthiouracil in the Canadian market. Given the medical necessity of this product for patients in Canada, Health Canada has added Propylthiouracil(PTU) 50 mg tablets to the List of Drugs for Exceptional Importation and Sale, as an interim measure to help mitigate the shortage. Halewood has partnered with Accelera Pharma Canada Inc. (APCI), who will import and distribute Halewood’s Propylthiouracil (PTU) 50 MG Tablets into Canada.

 

Information for Healthcare Professionals

  • Product Name: Propylthiouracil (PTU) 50 mg tablets
  • Product Usage: Propylthiouracil is an antithyroid drug used to treat hyperthyroidism in adults (including the elderly) and in children and adolescents aged 6 to 18 years. The drug is critical for the treatment of hyperthyroidism in special populations (e.g. pregnant women during the first trimester – where clinically appropriate)
  • Product Composition: Each tablet contains 50 mg of propylthiouracil
  • Other Ingredients: Contains lactose, Acacia, croscarmellose sodium, sodium laurilsulfate, magnesium stearate. Gluten free
  • Pharmaceutical Form: Tablet. White, circular biconvex tablet of approximately 6.5 mm by 3 mm
  • Fill Volume: 100 tablets / bottle

The UK product is labelled in English only, but both the English and French Summary of Product Characteristics, Package Leaflet for the User, and the Letter of Introduction are available online (below).

 

Links to key resources [English]

 

Links to key resources [French]

 

Importer Information

  • Name of Importer: Accelera Pharma Canada Inc. (APCI)
  • Accelera Pharma Canada Inc. Address: 3330 Ridgeway Drive, Unit 12, Mississauga, Ont. L5L 5Z9
  • Accelera Pharma Canada Inc. Telephone: 1 (855) 611-2724
  • Accelera Pharma Canada Inc. Website: http://apcipharma.com/

 

Marketing Authorisation Holder Information

  • Marketing Authorisation Holder: Halewood Chemicals Limited
  • Marketing Authorisation Holder Address: The Mill, Horton Rd, Heathrow, Stanwell Moor, Staines TW19 6BJ
  • Manufacturer: Surepharm Services Limited
  • Country of Origin: United Kingdom
  • Product Identifying Code: PL 00042/0205
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