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Transcript of Novartis CellChain™ Platform: CTL019 Ordering Process and ... · Doc No.: CLLCHN_TM_417_01_LTA...
Novartis CellChain™ Platform: CTL019 Ordering Process and Online Product Request Form
Novartis Oncology
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
This material is provided for background and educational
purposes by Novartis Pharma AG.
This material is for the sole use of the intended recipient
and may not be altered or further disseminated in any
fashion by the recipient for further use.
Business Use Only2
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Training Objective
Business Use Only3
To provide Treatment Center staff an overview of the ordering process for CTL019 in CellChain™,
the online platform used to support this process
If you have questions after training,please contact your Novartis Cell Therapy Network Manager or
the CTL019 Service Center at +800 100 10 100 or [email protected]
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
In this training, you will gain information about:
• “Patient to Patient” Chain of Identity
• Centralized Novartis Ordering process for CTL019
• CellChain™ Online Platform
• Online Product Request Form
• Product Cancellation/Replacement/Credit
• Support available from the CTL019 Service Center
Business Use Only4
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
CTL019 “Patient to Patient” Chain of Identity road map
• Patients must always sign the Patient Consent form, indicating that Novartis can use their T-cells to manufacture KYMRIAH. In some countries, patients must also sign a Data Privacy form.
Business Use Only5
Patient
Apheresis facility
(cell collection)
Cell processing
(cryopreservation) Transport
to Novartis
Cell processing
(preparation for infusion)Transport to EU
Distribution Hub
Manufacturing at Novartis
Transport
to Site
Name, DOB,Batch ID
Name, DOB,Batch ID, DIN/APH ID
Name, DOB,Batch ID, DIN/APH ID
Name, DOB,Batch ID, DIN/APH ID
––––––––––––––
Only Batch ID passed to Manufacturing
Name, DOB,Batch ID, DIN/APH ID
––––––––––––––
On FinalProduct Label
Name, DOB,Batch ID, DIN/APH ID
Name, DOB,Batch ID, DIN/APH ID
DOB, date of birth; EU, European Union; ID, identification; NPC, Novartis Pharmaceuticals Corporation; NPhAG, Novartis Pharma AG.
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
CTL019 Centralized Order Process
Novartis Oncology – Region Europe
• Manages Overall Onboarding Processand Regional Infrastructure
• Manages Product Ordering Process with the Novartis Technical Operations organization through the CTL019 Service Center
• Coordinates with Novartis’ local organizationsto supply the product at country level
Business Use Only6
CellChain™ Online
Order Process
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
CTL019 Order Process Overview
Business Use Only7
CTL019 Service Center +800 100 10 100
Order Status in CellChain™
Dashboard
CellChain™ Online
Order Process
CellChain™ Online Ordering Platform Overview
Novartis Oncology
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
CTL019 Order Process Overview
Business Use Only9
Final Product Shipped to
hospital cell lab,
who confirms
receipt
InvoiceNovartis invoices
hospital after
hospital cell lab
receives product
Step 1 Step 2 Step 3 Step 4
ProductRequest
PatientIdentification
Apheresis
• Product Request submitted
• Batch ID assigned by Novartis
(initiates Chain of Identity)
• Product Request approved
• Apheresis request generated by
Novartis and sent to network site
• Apheresis Data Form submitted
• Apheresis Data Form approved
• Collected cells (Apheresis
Material) are cryopreserved and
shipped to Novartis
Manufacturing begins after the following are
received:
• Product Request• Patient Cells/
Cryopreserved Apheresis
Manufacturing is on a first-in,
first-manufactured basis
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Apheresis
CTL019 Order Process Overview
(continued)
Business Use Only10
Step 2
Product Request
Pharmacists
CAR-T/Transplant
Coordinator
Treating Physicians
Apheresis
CenterCell Lab Staff
CellChain™ Online Ordering system
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
CTL019 Order Process Overview(continued)
Business Use Only11
Step 2
*Apheresis and cryopreservation must occur prior to completion of the Apheresis Data Form. Cryopreserved
Apheresis Material may be collected up to 30 months before the start of manufacturing.
Apheresis Data Form submitted
Apheresis Data Form approved
Cryopreserved collected cells
(Apheresis Material)* are shipped to Novartis
Apheresis request
generated by Novartis and sent
to network site
Batch ID assigned by
Novartis (initiates Chain of Identity)
Treatment
Center
submits a
Product
Request
Product Request details verified
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Apheresis
CTL019 Order Process Overview(continued)
Business Use Only12
Step 2
Product Request
Pharmacists
CAR-T/Transplant
Coordinator
Treating Physicians
Apheresis
CenterCell Lab Staff
CellChain™ Online Ordering system
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Product Request Submission in CellChain™
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Product Request Platform: CellChain™
Product Requests can be submitted using the Novartis online ordering platform, CellChain
• Novartis will accept Product Requests only from authorized personnel at CTL019 Treatment Centers who are qualified to prescribe CTL019
• A second-person (for example, a pharmacist) review at the Treatment Center is required to verify the accuracy of information in the product request and confirm the product order
• Order approval must be performed by a Treatment Center staff member other than the prescriber who initiated the order
• Multiple staff members should be trained, so a second-person review can be completed without delay
14 Business Use Only
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Product Request Process Overview
15
Submit Product
Request in
CellChain™
E-mail Notification
Sent to Verify Order
Verify/Approve
Order in CellChain
1 2
Business Use Only
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
CellChain™ Access
The CellChain system will permit access only to authorized individuals with a personal username and password.
To receive access, you need to:
1. Complete this training
2. Submit a completed CellChain Access Request Form to Novartis
3. Read and acknowledge the Data Privacy Policy that is provided along with the Access Request Form
You will receive an e-mail from [[email protected]] with the subject line “Welcome to CellChain” that will contain your Username and a link to access the application. Follow the directions to set up your account.
CellChain is supported by
Microsoft Internet Explorer
versions 9-11 and Apple Safari version
11.x. Current versions of Microsoft Edge,
Mozilla Firefox, and
Google Chrome are also compatible.
16 Business Use Only
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
CellChain™ Account: Reset Your Password on First Login
The first time you log in to CellChain™, you
will be prompted to change your password
Notice the specified password length and
complexity requirements
17 Business Use Only
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
CellChain™ Account: Accept Novartis’ Privacy Policy on First Login
The first time you log in to CellChain™, you will be
prompted to accept Novartis’ CellChain Website
Privacy Policy
You can view details of the Privacy Policy by accessing the
provided link
Click I Accept to continue
18 Business Use Only
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Logging in to CellChain™
Please note:
• Navigate to CellChain via the link received by
e-mail from [email protected]
• After five login attempts with an incorrect
password, the system will lock you out for
30 minutes
• If you are locked out of the application, please call
the CTL019 Service Center at +800 100 10 100
• The system will automatically log out users after
15 idle minutes
19 Business Use Only
Login Screen
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Adding a New Product Request in CellChain™
• After you log in, the Dashboard will be displayed
• The Dashboard is a single location for you to:
– Add new requests
– Track the status of pending requests
– Track existing orders from your site
Click Add a
new request
20 Business Use Only
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
City Center Hospital
Entering a Product Request in CellChain™
Treatment Information
In the Indication/Clinical Trial
section, from the drop-down
menu, select the appropriate
disease state for the
identified patient
In the Prescriber section,
from the drop-down menu,
select the prescriber who
is treating the identified
patient
21 Business Use Only
QUALIFIED PRESCRIBER
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Entering a Product Request in CellChain™
Patient Information
Enter the patient’s
name, using care
to ensure correct
spelling
Note that for a
Clinical Trial, the
form will update to
require only the
patient initials to be
entered
Enter patient date
of birth in the
DD/MMM/YYYY
format
Enter patient weight, in kilograms, at
the time of the Product Request
22 Business Use Only
Enter the hospital
patient ID, which is
the unique identifier
used by your
institution to track
your patient. Use of
this identifier can
help lookup the
patient record
Note that this field
will only be visible if
your hospital
requested for it
during the
onboarding
process
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
City Center Cancer InstituteNorth Street 101, 12345 City Center, Germany
North Street 105, 12345 City Center, GermanyCity Center Cancer Institute
Entering a Product Request in CellChain™
Leukapheresis Collection Information
Enter the estimated date (in your time zone)
on which the pick up of the cryopreserved
Leukapheresis material should be scheduled
If the autopopulated
addresses are
not correct, call
the CTL019 Service
Center at
+800 100 10 100
Select the
Leukapheresis
collection center
from the drop-
down menu
Select the
cryopreserved
Leukapheresis
pickup location
from the drop-
down menu
23 Business Use Only
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
City Center Cancer InstituteNorth Street 101, 12345 City Center, Germany
City Center Cancer InstituteNorth Street 101, 12345 City Center, Germany
Entering a Product Request in CellChain™
Product Delivery Information
If the autopopulated
addresses are
not correct, call
the CTL019 Service
Center at
+800 100 10 100
Select the
infusion center
from the drop-
down menu
Select the
finished product
ship to location
from the drop-
down menu
24 Business Use Only
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Click Browse to select the appropriate signed patient notice from your
computer, and then click Upload to upload it. A confirmation note will be
displayed after a successful upload
It is recommended to upload the signed patient notice for documentation
purposes in case of audits and inspections
25 Business Use Only
Entering a Product Request in CellChain™ Patient Notice
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Select the step you want to take with this order:
• Save (return later to update/submit)
• Submit (send to Novartis)
• Cancel (delete all information)
I confirm that the patient notice for Kymriah was presented to the patient/legal guardian prior to submitting this order form,
the patient/legal guardian has been fully informed about the risks and procedures involved in receiving KYMRIAH and,
where needed, has provided consent to allow Novartis (1) to collect, process and keep certain personal data; and (2) to
process and store the patients T cells. We will store the signed original of the patient notice in the patient’s record at our
institution.
I confirm that we have, or will, provide the following materials to the patient/legal guardian prior to the infusion of KYMRIAH:
(1) Package Leaflet; (2) Patient Education Leaflet; and (3) Patient Alert Card.
Read and confirm the attestation by checking the box
26 Business Use Only
Entering a Product Request in CellChain™
AttestationPatients must always sign the Patient Consent form, indicating that Novartis can use their T-cells to manufacture KYMRIAH. In some countries, patients must also sign a Data Privacy form.
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
When a product request does not include an uploaded patient notice
during submission, a warning will be displayed.
You can either return to upload the patient notice or continue to submit
the request without uploading the patient notice.
27 Business Use Only
Entering a Product Request in CellChain™
Patient Notice Reminder
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Product Request Status in CellChain™
After you submit the request, you will be returned to the dashboard.
Here, you can view and track the status of the new request and existing orders:
This flag indicates
the order has not
yet been approved
by a second person
at the ordering site
(The next section
discusses this step)
28 Business Use Only
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Saved Product Requests in CellChain™
If you clicked the option to save your work, you will receive this confirmation:
Your work on this product request has been saved but not submitted.
You can access it again from the Dashboard
Return to Dashboard
29 Business Use Only
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Second-Person Approval of Product Request in CellChain™
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Overview of Second-Person Approval in CellChain™
• After the product request is submitted, an e-mail alert will be sent to all Treatment Center staff with CellChain™ access to approve the product request
• To approve the product request, a trained CellChain user (other than the submitter) must click the hyperlink in the e-mail. Clarify whether the second-person approval will need to be conducted by a Pharmacist at your institution
• The hyperlink will take the user to the CellChain approval page
• The approver will review the request information and reenter the patient’s last name
• If all information is correct, approve the request. If anything is incorrect, reject the request
31 Business Use Only
City Center Cancer InstituteCommercial – DLBCL - Description HCP_User_001
yes 14-Apr-1999 45.5
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Order Approved in CellChain™
• “Order: Approved” does not mean a manufacturing day or time is reserved
• Manufacturing will begin only after the cryopreserved Leukapheresis material is received by
Novartis
– After Novartis has confirmed receipt of the order, all Treatment Center CellChain users will receive
a confirmation e-mail
After approval, the
order status in
your dashboard
will now state
“Order: Approved”
32 Business Use Only
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Rejecting a Product Request in CellChain™
If you Reject the product request, you will be
prompted to enter a reason for rejection
Please be as specific as possible (eg, incorrect
spelling of patient first name – should be “Jane”;
wrong ship-to address – should be 123 Street Road)
NOTE: Rejecting a Product Request is not considered a cancellation under the Cancellation Policy
33 Business Use Only
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
City Center Cancer Institute
Fixing a Rejected Product Request in CellChain™
Any qualified user at the
Treatment Center (including
the person who rejected it)
will be able to fix the error(s)
that caused the rejection
and resubmit for approval
The subsequent second-
person approver will need to
be a different individual from
the person who fixed the
error and resubmitted the
product request
34 Business Use Only
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
CellChain™ Dashboard Overview
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
CellChain™ Dashboard View of Order Status
Draft order
(not yet submitted)
Order waiting for
second-person
approval
Flags show
current status
36 Business Use Only
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
CellChain™ Dashboard View of Order Status
(continued)
Product Request was
rejected (needs to be
fixed and resubmitted)
Product Request was
approved
Product Request
was approved,
and cryopreserved
apheresis was received
Flag shows
rejected status
This color indicates that action is needed to
proceed to next step.
Call the CTL019 Service Center with questions
37 Business Use Only
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
CellChain™ Dashboard View of Order Status
(continued)
Manufacturing has started
Manufacturing is
completed; Product
now in QA testing
Manufacturing and QA
testing are completed
Estimated ship
dates* for final
products
*Estimated ship dates are subject to change and centers will be notified of the final shipment date.
38 Business Use Only
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Final product has been delivered
39 Business Use Only
CellChain™ Dashboard View of Order Status
(continued)
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
ApheresisProduct Request
Pharmacists
CART/Transplant
Coordinator
Treating Physicians
Apheresis
CenterCell Lab Staff
CTL019 Order Process Overview
Business Use Only40
Step 2
CellChain™ Online Ordering System
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Cancellation, Product Replacement and Credit Requests
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Cancellation, Product Replacement, and Credit Request
*Product received free of charge is not eligible for a credit.
Product Cancellation
Final Product Received by
Hospital
Unusable
Product
Replacement/
Credit Request*
42 Business Use Only
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Product Cancellation
• To cancel an order, a Product Cancellation Form must be submitted to the CTL019 Service Center at [email protected] via secure e-mail
• The form must be signed by the CTL019 Treatment Center physician and pharmacist qualified to prescribe CTL019
• Cancellation is not complete until a confirmed CTL019 cancellation notice is received
• For full terms and conditions, please see the Cancellation, Unusable Product Replacement, and Credit Policy
• Note: during infusion center qualification, a Center ID will be assigned by Novartis and provided in the qualification confirmation letter
43
An order cannot be canceled after a CTL019 Treatment Center accepts
receipt of the CTL019 product
Business Use Only
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Unusable Product Replacement and Credit Request
• The Unusable Product Replacement and Credit Request Policy identifiessituations in which CTL019 may be considered unusable:
44
1. Qualified treatment site or cell lab human error, rendering CTL019 unusable
2. CTL019 temperature excursions at qualified treatment site or cell lab not covered under
site’s or cell lab’s insurance policy
3. CTL019 damaged during shipment but not recognized until after receipt
4. CTL019 temperature excursion during transportation but not recognized until after
receipt
5. Product quality issue identified during product thawing process and/or prior to infusion
6. CTL019 has expired (credit request must be submitted within 30 days of expiration)
7. Product cannot be used due to patient condition
Product
replacement
(if available)
or credit
Credit only*
When requesting a replacement or a credit, an Unusable Product
Replacement and Credit Request Form must be submitted
*Product received free of charge is not eligible for a credit.
Business Use Only
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Unusable Product Replacement and Credit Request (continued)
• To request a replacement dose (if one is available for the patient) or a credit, an Unusable Product Replacement and Credit Request Form must be submitted to the CTL019 Service Center at [email protected] via secure e-mail
• All requests must follow the replacement or credit process and satisfy the terms of the Cancellation, Unusable Product Replacement, and Credit Policy
• The form must be signed by the CTL019 Treatment Center physician and pharmacist qualified to prescribe CTL019
• Product received free of charge is not eligible for a credit
• Note: during infusion center qualification, a Center ID will be assigned by Novartis and provided in the qualification confirmation letter
45 Business Use Only
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Support available from the CTL019 Service Center
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
+800 100 10 100
Gettyimages/Epifantsev/467483388
Contact the CTL019 Service Center for Support
• The CTL019 Service Center is your first point of contact for CTL019 order help with:
• CTL019-related logistical questions
• CellChain™ user support (eg, new user, login help, data change support)
• PRF data entry support/case management
• Organization of pickup and delivery of apheresis material, finished product
Business Use Only47
Doc No.: CLLCHN_TM_417_01_LTA Doc Version: 2.0
Updated 08/2018
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
+800 100 10 100
Gettyimages/Epifantsev/467483388
Contact the CTL019 Service Center for Support
(continued)
• Updates on status of manufacturing process and expected delivery date
• Cancellation/Product replacement requests/Credit requests
• Product quality issues
• Printed RMP/other material requests
• General questions about CTL019 management
Business Use Only48
Please see the Summary of Product Characteristics for CTL019, including Package Leaflet.
Thank you
Novartis Pharma AG
CH-4002 Basel Switzerland © 2018 Novartis 9/18 G-KYH-1194555