We operate or partner to make our medicines available in more than 70 countries. To report an adverse event or a product complaint, or to request information about our products, please visit our Drug Safety or Medical Information pages.
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This information is intended for U.S. residents only
Sunosi U.S. Patient Website
Sunosi U.S. Healthcare Professionals Website
| Austria | SmPC | PIL | Italy | SmPC | PIL |
| Belgium - DE | SmPC | PIL | Latvia | SmPC | PIL |
| Belgium - FR | SmPC | PIL | Lithuania | SmPC | PIL |
| Belgium - NL | SmPC | PIL | Malta | SmPC | PIL |
| Bulgaria | SmPC | PIL | Netherlands | SmPC | PIL |
| Croatia | SmPC | PIL | Norway | SmPC | PIL |
| Czech Republic | SmPC | PIL | Poland | SmPC | PIL |
| Denmark | SmPC | PIL | Portugal | SmPC | PIL |
| Estonia | SmPC | PIL | Romania | SmPC | PIL |
| Finland | SmPC | PIL | Slovakia | SmPC | PIL |
| France | SmPC | PIL | Slovenia | SmPC | PIL |
| Germany | SmPC | PIL | Spain | SmPC | PIL |
| Greece | SmPC | PIL | Sweden | SmPC | PIL |
| Hungary | SmPC | PIL | United Kingdom | SmPC | PIL |
| Iceland | SmPC | PIL |
Download Full Prescribing Information
This information is intended for U.S. residents only
Xyrem U.S. Patient Website
Xyrem U.S. Healthcare Professionals Website
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This information is intended for U.S. residents only
Defitelio U.S. Healthcare Professionals Website
| Austria | SmPC | PIL | Italy | SmPC | PIL |
| Belgium - DE | SmPC | PIL | Japan | JPI | |
| Belgium - FR | SmPC | PIL | Latvia | SmPC | PIL |
| Belgium - NL | SmPC | PIL | Lithuania | SmPC | PIL |
| Brazil | SmPC | PIL | Luxembourg | SmPC | PIL |
| Bulgaria | SmPC | PIL | Malta | SmPC | PIL |
| Canada - EN | PM | PI | Netherlands | SmPC | PIL |
| Canada - FR | PM | PI | Norway | SmPC | PIL |
| Croatia | SmPC | PIL | Poland | SmPC | PIL |
| Cyprus | SmPC | PIL | Portugal | SmPC | PIL |
| Czech Republic | SmPC | PIL | Romania | SmPC | PIL |
| Denmark | SmPC | PIL | Slovak Republic | SmPC | PIL |
| Estonia | SmPC | PIL | Slovenia | SmPC | PIL |
| Finland | SmPC | PIL | Spain | SmPC | PIL |
| France | SmPC | PIL | Sweden | SmPC | PIL |
| Greece | SmPC | PIL | United Kingdom | SmPC | PIL |
| Germany | SmPC | PIL | Israel | PI | |
| Hungary | SmPC | PIL | South Korea | SmPC | |
| Iceland | SmPC | PIL | |||
| Ireland | SmPC | PIL |
Due to quality and manufacturing issues with product manufactured by PBL over the past few years, product made available to Jazz by PBL is not ready for release to patients. Jazz needs to perform the following activities to ensure the suitability of the product for patients:
In addition, many batches have additional and specific quality and/or manufacturing issues that require additional activities and time to ensure product is suitable for release to patients. These activities include third-party analytical testing, expert consultant review, clinical risk assessments and engagement with regulatory authorities. Learn more
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This information is intended for U.S. residents only
Erwinaze U.S. Patient Website
Erwinaze U.S. Healthcare Professionals Website
NOTICE OF SPECIAL HANDLING INSTRUCTIONS: Use a 5-micron filter needle for withdrawing the reconstituted product from vials of Erwinase from Batch 184. Click here for Dear Healthcare Provider Letter.
This product is authorised in the following countries:
| Argentina* | Malaysia* | ||||
| Austria | SmPC | PIL | Netherlands | SmPC | PIL |
| Canada - EN | PM | New Zealand* | |||
| Canada - FR | PM | Norway* | |||
| Denmark* | Poland | SmPC | PIL | ||
| France | SmPC | PIL | Portugal | SmPC | PIL |
| Germany | SmPC | PIL | South Korea | SmPC | |
| Ireland | SmPC | PIL | Sweden* | ||
| Lebanon* | United Kingdom† | SmPC | PIL | ||
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This information is intended for U.S. residents only
Vyxeos U.S. Patient Website
Vyxeos U.S. Healthcare Professionals Website
| Austria | SmPC | PIL | Italy | SmPC | PIL |
| Belgium - DE | SmPC | PIL | Latvia | SmPC | PIL |
| Belgium - FR | SmPC | PIL | Lithuania | SmPC | PIL |
| Belgium - NL | SmPC | PIL | Luxembourg | SmPC | PIL |
| Bulgaria | SmPC | PIL | Malta | SmPC | PIL |
| Croatia | SmPC | PIL | Netherlands | SmPC | PIL |
| Cyprus | SmPC | PIL | Norway | SmPC | PIL |
| Czech Republic | SmPC | PIL | Poland | SmPC | PIL |
| Denmark | SmPC | PIL | Portugal | SmPC | PIL |
| Estonia | SmPC | PIL | Romania | SmPC | PIL |
| Finland | SmPC | PIL | Slovak Republic | SmPC | PIL |
| France | SmPC | PIL | Slovenia | SmPC | PIL |
| Germany | SmPC | PIL | Spain | SmPC | PIL |
| Greece | SmPC | PIL | Sweden | SmPC | PIL |
| Hungary | SmPC | PIL | United Kingdom | SmPC | PIL |
| Iceland | SmPC | PIL | |||
| Ireland | SmPC | PIL |
