Advocacy & Knowledge
UPDATE: Falsified Iclusig traded globally, discovered in Malaysia (new), Turkey, Switzerland, Argentina and Internet sales with UK/Ireland product batch numbers PR072875 (45mg) and 25A19E09 (15mg)
The World Health Organisation (WHO) has issued a medical product alert today that falsified versions of ICLUSIG (Ponatinib) have been discovered in Turkey, Argentina and Switzerland, and in Internet sales. The falsified (counterfeit) medicines do not contain any of the CML drug ponatinib, but only low quantities of paracetamol. These falsified medicines are not going to have any effect against CML. The falsified English language packs contain the lot/batch numbers
- PR072875 (UK/Ireland pack, English language, 60 tablets á 45mg, Expiry date 12/2019) and
- 25A19E09 (UK/Ireland pack, English language, 30 tablets á 15mg, Expiry date 10/2020).
In addition, on 20 February 2019, we were notified of a new falsified Iclusig pack:
- PR0834170 (German pack, German language, 30 tablets á 45 mg, Expiry date 06/2020).
The WHO page which is available in English, French, Russian and Spanish provides photos of the packages and pill bottles so patients can find the batch numbers. The WHO page has not yet been updated on the third falsified pack, which is expected those days.
To identify falsified product batches both the batch number and packaging (language, country of the pack) are important.
No UK/Ireland ORIGINAL product has been produced by the manufacturers Incyte/Takeda that carries those batch numbers in languages from those countries and with these languages. Products with the above batch numbers, country and language are most likely falsified.
In case of PR072875, the counterfeiters used this genuine lot number originally issued on a German ICLUSIG box and created a falsified UK packaging. In case of 25A19E09 and PR0834170, no original products were manufactured wih those batch numbers.
And so far, the manufacturer and medicines authorities are NOT aware of additional FALSIFIED ponatinib products bearing different batch numbers, so patients taking Ponatinib with other batch numbers than those listed above should NOT yet be concerned.
Patients, physicians and distributors should make sure to obtain CML medication from validated and reliable sources that are able to demonstrate the authenticity of origin of the products.
In case of any concern, check the batch number against the two identified falsifications, and contact Incyte Medical Information in case of persisting suspicion at eumedinfo@incyte.com or +800 00027423.
Please let the CML Advocates Network know via info@cmladvocates.net if you come across the falsified product with these batch numbers, so we know whether the falsified medicines have been shipped to any other regions or countries. National CML patient groups are also encouraged to notify their local health authorities and leading physicians.
Important Notice: Changes to the CML Horizons 2019 Conference
Important Notice: Changes to the CML Horizons 2019 Conference
Dear Members & friends of CML Advocates Network,
This is a very important announcement and follows up from our notice a few weeks ago named "emerging news regarding CML Horizons 2019" following the tragic events that took place in Nairobi, Kenya.
After careful consideration, discussions and investigation the CML Steering committee has decided that at this point of time it is better for the safety of our members to change the location of CML Horizons 2019 and at such short notice we will need to come back to mainland Europe. Horizons will now be held in Lisbon, Portugal at the Lisbon Marriott Hotel, Avenida dos Combatentes 45, Lisbon 1600-042 Portugal and the dates still remain the same 17-19 May 2019.
This does not mean that in future years we will not take Horizons to another continent and we will work hard to try and make this happen for 2020 and we will keep you updated.
What does this change of location mean for all our members? We will need you to start registration ASAP and depending on the country you come from if you need a Schengen Visa this process can take 6-9 weeks so we need you to take the following steps.
Step 1: Register for CML Horizons 2019 here: https://www.cmladvocates.net/cmlhorizons
Step 2: At the following link is a list of the nationalities that must process a Visa: https://www.vistos.mne.pt/en/short-stay-visas-schengen/general-information/who-needs-a-visa#countries-2
Step 3: Once you have registered, we will be in contact with you in regards to support documents for your visa application.
For those members who have already registered: Vanja and Lidija will be in touch with you soon and there is NO NEED to re-register. For those who need a VISA we will need to send you new documents for a Schengen Visa to Portugal and new flight itinerary.
Finally, please note that this decision did not come easy and does not take away from why we had chosen Nairobi as our original destination and that is to honour our dearly departed Ferdinand Micho who was the leader in the fight of CML in Africa and the Middle East but also for the challenges that CML patients face in law and middle-income countries in access to treatment and monitoring.
We look forward to seeing you all soon and please should you have any questions at all please do not hesitate to contact us.
Warm Regards
Giora and Lidija on behalf of the CML Advocates Steering Committee
CML Advocates Network
Falsified Iclusig traded globally, discovered in Turkey, Switzerland, Argentina and Internet sales with UK/Ireland product batch numbers PR072875 (45mg) and 25A19E09 (15mg)
The World Health Organisation (WHO) has issued a medical product alert today that falsified versions of ICLUSIG (Ponatinib) have been discovered in Turkey, Argentina and Switzerland, and in Internet sales. The falsified (counterfeit) medicines do not contain any of the CML drug ponatinib, but only low quantities of paracetamol. These falsified medicines are not going to have any effect against CML. The falsified English language packs contain the batch numbers
- PR072875 (UK/Ireland pack, English language, 60 tablets á 45mg, Expiry date 12/2019) and
- 25A19E09 (UK/Ireleand pack, English language, 30 tablets á 15mg, Expiry date 10/2020).
The WHO page which is available in English, French, Russian and Spanish provides photos of the packages and pill bottles so patients can find the batch numbers.
To identify falsified product batches both the batch number and packaging (language, country of the pack) are important.
No UK/Ireland ORIGINAL product has been produced by the manufacturers Incyte/Takeda that carries those batch numbers. - so products with the above two batch numbers in UK/Ireland and English language are most likely falsified. In case of PR072875, the counterfeiters used this genuine lot number originally issued on a German ICLUSIG box and created a falsified UK packaging.
And so far, the manufacturer and medicines authorities are NOT aware of additional FALSIFIED ponatinib products bearing different batch numbers, so patients taking Ponatinib with other batch numbers than those listed above should NOT yet be concerned.
Patients, physicians and distributors should make sure to obtain CML medication from validated and reliable sources that are able to demonstrate the authenticity of origin of the products.
In case of any concern, check the batch number against the two identified falsifications, and contact Incyte Medical Information in case of persisting suspicion at eumedinfo@incyte.com or +800 00027423.
Please let the CML Advocates Network know via info@cmladvocates.net if you come across the falsified product with these batch numbers, so we know whether the falsified medicines have been shipped to any other regions or countries. National CML patient groups are also encouraged to notify their local health authorities and leading physicians.
Welcome, Ameleg, Mexico! Now 120 patient organisations from 90 countries in the CML Advocates Network
We are proud to welcome a new member organisation to the CML Advocates Network: Asociacion Mexicana de Leucemia y GIST, A.C. based in Mexico.
The CML Advocates Network now totals at 120 member organisations in 90 countries worldwide!
See the list of CML groups in the Network on our world map.
Welcome, ASUL, Uruguay!
Now 121 patient organisations from 91 countries in the CML Advocates Network
We are proud to welcome a new member organisation to the CML Advocates Network: Asociación Uruguaya de Leucemia ASUL, based in Uruguay.
The CML Advocates Network now totals at 121 member organisations in 91 countries worldwide!
Read more to see the list of CML groups in the Network on our world map.