Drug Safety
Drug Safety
Patient safety is of paramount importance to Jazz Pharmaceuticals. It is our ethical and regulatory responsibility to monitor the safety of the medicines we develop from their preclinical stage through clinical testing and prescribing. Timely reporting to Drug Safety is critical to enable compliance with regulatory requirements.
If you are a patient reporting occurrence of adverse events or if you have questions about your condition, please contact your health care practitioner.
Reporting an Adverse Event or Product Complaint in North America
To report an adverse event or product complaint in the US, Canada, or Mexico for Defitelio®, Epidiolex®, Rylaze®, Sativex®, Vyxeos®, Xyrem®, Xywav™, Zepzelca®, or Ziihera® please contact us at one of the following:
Phone: 1-800-520-5568
Email: AEReporting@jazzpharma.com
Additionally, adverse events or product complaints where the package indicates the product Erwinaze® (in the U.S.) or Erwinase® (in Canada) is distributed by Jazz, may also be reported using the contact information below.
Reporting an Adverse Event or Product Complaint in Europe and International
To report an adverse event or a product complaint in Europe and International, please click the arrow next to the product name(s) and contact us using the appropriate country-specific telephone or email address listed in the section below. Please note, not all products are available in every country listed on this page.
Defitelio®, Kidrolase®, Vyxeos® Liposomal, Enrylaze® or Erwinase® batches distributed by Jazz
| Asia-Pacific Region T: +61 1800577422 E: AEReporting@jazzpharma.com | Austria T: +43 800 018264 E: AEReporting@jazzpharma.com | Belgium, The Netherlands, and Luxembourg For a Dutch-speaking call handler – T: +31 207176898 For a French-speaking call handler – T: +33 176728925 For a German-speaking call T: +49 (0) 3022 957821 E: AEReporting@jazzpharma.com |
| Canada T: +1 800 520 5568 E: AEReporting@jazzpharma.com | Denmark T: +45 69918419 E: AEReporting@jazzpharma.com | France T: +33 176728925 E: Vigilance.FR@jazzpharma.com |
| Germany T: +49 (0) 3022 957821 E: AEReporting@jazzpharma.com | Italy T: +39 0687500850 E: AEReporting@jazzpharma.com | Other European/International countries/regions T: +353 1 968 1631 (may include an international phone call charge) E: AEReporting@jazzpharma.com |
| Poland T: +48 221042097 E: AEReporting@jazzpharma.com | Portugal T: +351 308 805 626 E: AEReporting@jazzpharma.com | Republic of Ireland T: +353 1 968 1631 (local phone number) E: AEReporting@jazzpharma.com |
| Spain T: +34 914142493 E: AEReporting@jazzpharma.com | Sweden T: +46 406688521 E: AEReporting@jazzpharma.com | Switzerland T: +41 800 100 005 E: AEReporting@jazzpharma.com |
| UK T: +44 8081890387 (toll-free phone number) T: +44 20 3307 4847 (local phone number) E: AEReporting@jazzpharma.com |
Epidyolex®
| Austria T: +43 800 018264 E: AEReporting@jazzpharma.com | Belgium, The Netherlands, and Luxembourg For a Dutch-speaking call handler – T: +31 207176898 For a French-speaking call handler – T: +33 176728925 For a German-speaking call handler – T: +49 (0) 3022 957821 E: AEReporting@jazzpharma.com | Denmark T: +45 69918419 E: AEReporting@jazzpharma.com |
| France T: +33 176728925 E: Vigilance.FR@jazzpharma.com | Germany T: +49 (0) 3022 957821 E: AEReporting@jazzpharma.com | Italy T: +39 (0)800959164 E: AEReporting@jazzpharma.com |
| Other European/International countries/regions T: +353 1 968 1631 (may include an international phone call charge) E: AEReporting@jazzpharma.com | Spain T: +34 914142493 E: AEReporting@jazzpharma.com | Sweden T: +46 406688521 E: AEReporting@jazzpharma.com |
| Switzerland T: +41 800 100 005 E: AEReporting@jazzpharma.com | UK T: 44 8081890387 (toll-free phone number) T: +44 20 3307 4847 (local phone number) E: AEReporting@jazzpharma.com |
Sativex®
Sativex® distributors
Jazz (formerly GW Pharmaceuticals) developed and manufactures Sativex®. All adverse event reporting and product complaints for Sativex should be directed through the distributor in the respective country/region as listed below.
Australia and New Zealand
Chiesi Australia PTY LTD are the legally registered Sponsor for Sativex in Australia and New Zealand and are currently working with local health authorities to enable supply of Sativex in each country. For information on its availability in Australia and New Zealand, please contact Chiesi Australia:
P: 22 Gillman Street, Suite 3, Hawthorn East, Victoria 3123, Australia
T: +61 (0)3 9077 4486
E: customerservice.au@chiesi.com
Canada
Bayer Canada is our distribution partner in Canada and therefore any enquiries relating to Sativex from medical professionals in Canada should be directed to Bayer. If you are a medical professional in Canada and would like further information on Sativex please contact Bayer Canada using the following information:
T: (1) 800 265 7382
F: (1) 866 232 0565
E: canada.medinfo@bayer.com
Europe
Almirall S.A. is our distribution partner in Europe and therefore any enquiries relating to Sativex from medical professionals in Europe should be directed to Almirall using their website.
Sativex is approved and commercialized in the following countries in mainland Europe: Germany, Italy, Spain, Belgium, Luxembourg, Norway, Denmark, Sweden, Iceland, Portugal, Poland, Austria and Switzerland, while it is approved in France, Rep of Ireland, Finland, Czech Rep, Slovakia and The Netherlands but not yet available.
In all of these countries other than Switzerland the marketing authorization for Sativex is held by Jazz. The marketing authorization for Sativex in Switzerland is held by Almirall S.A.’s Swiss affiliate.
If you are a medical professional in Europe and would like further information on Sativex please contact Almirall using the following link:
Israel
Neopharm Ltd is GW’s partner in Israel and therefore any enquiries relating to Sativex from medical professionals in Israel should be directed to Neopharm using the following contact information.
Neopharm’ s medical department contact is: Medical Affairs Department.
T: +972 03 9373753
E: medinfo@neopharmgroup.com
Latin America
BRAZIL
In Brazil, we are partnered with Beaufour Ipsen Pharmaceuticals.
In Brazil Sativex has received marketing authorization under the brand name of Mevatyl® and is indicated as treatment for symptoms improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.
LATAM
Sativex has also received marketing authorization in Colombia and Chile for the same indication.
For other countries in Latin America (Chile, Colombia, Argentina and Peru) we are partnered with Biopas.
United Kingdom
Sativex is marketed in the UK by Jazz. If you are a medical professional and would like further information on Sativex® please contact us using the details below.
T: +44 8081890387 (toll-free phone number)
T: +44 20 3307 4847 (local phone number)
E: medinfo-uk@jazzpharma.com
Side effects should be reported. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk.