Drug Report History
Below you will find the report version history. When a report is updated, a new version of the report is created. The report history allows you to see the changes between versions. You can select two versions of the report to compare. The fields that were changed between versions will be highlighted in yellow.
The translation of reports creates two separate versions which is why some reports may not seem to have any differences. In this case, only the language field below will be highlighted in yellow.
| Version v10-FR | Version v4-FR | |
|---|---|---|
| Language | French | French |
| Date Updated | 2024-10-30 | 2024-10-30 |
| Drug Identification Number | 02248077 | 02248077 |
| Brand name | PEGASYS | PEGASYS |
| Common or Proper name | peginterferon alfa-2A injection | peginterferon alfa-2A injection |
| Company Name | PHARMAAND GMBH | PHARMAAND GMBH |
| Ingredients | PEGINTERFERON ALFA-2A | PEGINTERFERON ALFA-2A |
| Strength(s) | 180MCG | 180MCG |
| Dosage form(s) | SOLUTION | SOLUTION |
| Route of administration | SUBCUTANEOUS SUBCUTANEOUS | SUBCUTANEOUS SUBCUTANEOUS |
| Packaging size | pre-filled syringes 180 mcg/0.5 mL | pre-filled syringes 180 mcg/0.5 mL |
| ATC code | L03AB | L03AB |
| ATC description | IMMUNOSTIMULANTS | IMMUNOSTIMULANTS |
| Reason for shortage | Disruption of the manufacture of the drug. | Disruption of the manufacture of the drug. |
| Anticipated start date | 2024-10-29 | 2024-10-29 |
| Actual start date | 2024-10-29 | 2024-10-29 |
| Estimated end date | 2025-12-31 | 2025-12-31 |
| Actual end date | ||
| Shortage status | Actual shortage | Actual shortage |
| Tier 3 Status | No | No |
| Company comments | The sole manufacturer of Pegasys® API, Roche Diagnostics GmbH produced a final batch of peginterferon alfa-2a in 2017. Establishment of new API manufacturer for peginterferon alfa-2a, Loba biotech GmbH, Fischamend, Austria (affiliate of pharmaand GmbH) remains in progress. Before Roche Diagnotics GmbH permanently decommissioned the API production line, they produced a final batch in 2017 which was estimated to cover global demand for approximately 10 years. Pegasys® product demand has increased significantly due to recent changes in the market. As a result, the final product batch produced by Roche will not last for the intended period of approximately 10 years, and pharmaand GmbH (pharma&) has looked to expedite the manufacturing plan. pharma& committed to investing in the ongoing development and future certification of our bio-manufacturing capabilities at our wholly-owned manufacturing plant in Austria, Loba biotech GmbH.This is a significant investment and was required to transfer the active pharmaceutical ingredient (API) in Pegasys® to our new facility, which is a complex biologic treatment to manufacture, requiring 18 purification stages to ensure the highest quality and safety for the patient. | The sole manufacturer of Pegasys® API, Roche Diagnostics GmbH produced a final batch of peginterferon alfa-2a in 2017. Establishment of new API manufacturer for peginterferon alfa-2a, Loba biotech GmbH, Fischamend, Austria (affiliate of pharmaand GmbH) remains in progress. Before Roche Diagnotics GmbH permanently decommissioned the API production line, they produced a final batch in 2017 which was estimated to cover global demand for approximately 10 years. Pegasys® product demand has increased significantly due to recent changes in the market. As a result, the final product batch produced by Roche will not last for the intended period of approximately 10 years, and pharmaand GmbH (pharma&) has looked to expedite the manufacturing plan. pharma& committed to investing in the ongoing development and future certification of our bio-manufacturing capabilities at our wholly-owned manufacturing plant in Austria, Loba biotech GmbH.This is a significant investment and was required to transfer the active pharmaceutical ingredient (API) in Pegasys® to our new facility, which is a complex biologic treatment to manufacture, requiring 18 purification stages to ensure the highest quality and safety for the patient. |
| Health Canada comments |