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

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®.

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 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.

Defitelio®, Kidrolase®, Sunosi®, Vyxeos® Liposomal or Erwinase® batches distributed by Jazz

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)

Epidyolex®

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

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:

www.AlmirallMED.com

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
For Latin America we are partnered with Beaufour Ipsen Pharmaceuticals.

www.ipsen.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.

E: informedbrasil@ipsen.com

LATAM

Sativex has also received marketing authorization in Colombia and Chile for the same indication.

E: medinfo.latam@ipsen.com

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 (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.

Our Pharmacovigilance Privacy Notice outlines how Jazz Pharmaceuticals handles the processing of personal information when dealing with your adverse event report.