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.
Please call 1-800-520-5568 to report an adverse event or a product complaint for Defitelio®, Rylaze®, Sunosi®, Vyxeos®, Xyrem®, Xywav™ or Zepzelca® in the U.S.; or Defitelio®, Sunosi®, Vyxeos®, Xyrem®, or Zepzelca™ in Canada.
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.
Please call 1-833-424-6724 to report an adverse event or a product complaint for Epidiolex®.
To report an adverse event or a product complaint in Europe and International, please click the arrow next to the product name and call using the appropriate country-specific telephone number listed in the section below. Please note, not all products are available in every country listed on this page.
| Asia-Pacific Region T: +61 1800577422 | Canada T: +1 800 520 5568 | 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 3056796128 |
| France T: +33 176728925 | Germany T: +49 3056796128 | Italy T: +39 0687500850 |
| Denmark, Sweden T: +31 207176898 | Poland T: +48 221042097 | Portugal T: +351 308805626 |
| Republic of Ireland T: +353 1 968 1631 (local phone number) | Spain T: +34 914142493 | UK T: +44 8081890387 (toll-free phone number) T: +44 20 3307 4847 (local phone number) |
| Other European/International countries/regions T: +353 1 968 1631 (may include an international phone call charge) |
| UK T: +44 (0) 1223 238170 | Germany T: +49 (0) 3022 957821 | Belgium, Luxembourg T: +33 (0) 1 70 75 58 54 |
| France T: +33 (0) 1 70 75 58 54 | Spain T: +34 91 419 73 79 | Italy T: +39 06875 01801 |
| US T: +1 833 424 6724 | Other European/International countries/regions T: +44 (0) 1223 238170 |
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.
P: 22 Gillman Street, Suite 3, Hawthorn East, Victoria 3123, Australia
T: +61 (0)3 9077 4486
E: customerservice.au@chiesi.com
T: (1) 800 265 7382
F: (1) 866 232 0565
E: canada.medinfo@bayer.com
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:
Neopharm’ s medical department contact is: Medical Affairs Department.
T: +972 03 9373753
E: medinfo@neopharmgroup.com
Brazil
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.
T: +44 (0) 1223 238 170
E: medinfo@gwpharm.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.
