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Welcome to AstraZeneca Medical

You can use this site to report adverse events or product quality complaints for products of AstraZeneca, Alexion (AstraZeneca Rare Disease company), and other AstraZeneca companies according to the privacy notice included in its websites. You can also request medical information for the above-mentioned products.

If you are reporting an Adverse Event/Product Quality Complaint, select the country where the Adverse Event/Product Quality Complaint occurred, regardless of your location.

What can we help you with?

Select all that apply

Adverse events are sometimes known as side effects and are unwanted or unexpected events or reactions to a medicine or device.

Medical Information enquiries are medical or scientific questions relating to our medicines and devices.

Product quality complaints relate to a physical issue with a medicine or a device and/or its packaging.

Please select an option

Adverse Event Reporting

Adverse events are sometimes known as side effects and are unwanted or unexpected events or reactions to a medicine.

Medical Information Enquiry

Medical Information enquiries are medical or scientific questions relating to our medicines and devices.

Product Quality Complaint

Product quality complaints relate to a physical issue with a medicine or device and/or its packaging

Which best describes you?

I am a ...

If you are a healthcare professional, you can access further information about AstraZeneca medicines and devices via https://azmedical.com.

(Only select this option if you are sure the adverse event occurred as part of an AstraZeneca Early Access Program (EAP), Single Patient Compassionate Use (SiPCU), Post Trial Access (PTA) or Global Access to Medicine (GATM)).

AstraZeneca Medical

Patient Information

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

A program identification number provided by AstraZeneca. For EAPs and PTAs this may be a D-code (or other code provided by AstraZeneca), for SiPCU please enter “SiPCU”, for GATM please enter “GATM”. If you are unsure, please reach out to your AstraZeneca contact.

An identification code for the specific patient that has experienced the adverse event. If you are unsure, please reach out to your AstraZeneca contact.

Contact Information

Demographics

If the exact date is unknown, please enter month and year, or year.

Height

Weight

Height

Weight

Last Menstrual Date
Due Date

Reporter Information

It looks like you are reaching out on behalf of an HCP. Please provide details about yourself.

Health Care Provider

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Contact Information

Caregiver Information

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Contact Information

Your Information

Which best describes your role in AstraZeneca?

I am a ...

Please enter your Patient Support Program or Market Research Program number here. For all other programs, please tick ‘Not applicable’

AZ initial aware date*

ODCP vendors are requested to enter the Patient ID or Vendor Case Reference ID in this section. Please clearly specify which information is provided, Patient ID or Vendor Case Reference ID, as follows: "Pat ID: [xxx]" or "Ref ID: [yyy]" and ensure your entry does not exceed 20 characters. Addtional information can be included in (Medication & Event Relationship section) ensure it does not contain PII data.

Suppliers of Organized Data Collection Programs, such as Patient Support Programs, Market Research, Non-Interventional Studies, etc., are requested to fill in this field with either the Vendor Local Reference ID or Patient ID, and to clearly specify which data is being included. Use one of the following formats:

To enter only the Vendor Reference ID, write: "Ref ID: [yyy]"

To enter only the Patient ID, write: "Pat ID: [xxx]"

Warning: Make sure that the data entered does not exceed the 20-character limit.

If it is necessary to provide both identifiers, include them exclusively in the free text field located in the "Relationship between Medication and Event" section as follows:

"Pat ID: [xxx]; Ref ID: [yyy]"

Patient Information

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

A program identification number provided by AstraZeneca. For EAPs and PTAs this may be a D-code (or other code provided by AstraZeneca), for SiPCU please enter “SiPCU”, for GATM please enter “GATM”. If you are unsure, please reach out to your AstraZeneca contact.

An identification code for the specific patient that has experienced the adverse event. If you are unsure, please reach out to your AstraZeneca contact.

Contact Information

Demographics

If the exact date is unknown, please enter month and year, or year.

Height

Weight

Height

Weight

Last Menstrual Date
Due Date

Caregiver Information

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Contact Information

Reporter Information

It looks like you are reaching out on behalf of an HCP. Please provide details about yourself.

Health Care Provider

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

Contact Information

Patient Information

Pharmaceutical companies are required to report certain adverse events occurring in Northern Ireland to the European Medicines Agency.

Required by the health authorities.

A program identification number provided by AstraZeneca. For EAPs and PTAs this may be a D-code (or other code provided by AstraZeneca), for SiPCU please enter “SiPCU”, for GATM please enter “GATM”. If you are unsure, please reach out to your AstraZeneca contact.

An identification code for the specific patient that has experienced the adverse event. If you are unsure, please reach out to your AstraZeneca contact.

Contact Information

Demographics

If the exact date is unknown, please enter month and year, or year.

Height

Weight

Height

Weight

Last Menstrual Date
Due Date

Health Care Provider

Health Care Provider’s Details

Health Care Provider’s Contact Information

Please provide at least one contact method

Adverse Event Medication / Device

Please add each medication / device separately using the Add Medication / Device button.

Expiration Date

Please refer to the indications and usage described in the Japanese product information when entering the reason for taking the medication.

Medication dates

Start Date

If the exact date is unknown, please enter month and year, or year.

End Date

If the exact date is unknown, please enter month and year, or year.

Vaccination Details

Dose 1

Expiration Date

If the exact date is unknown, please enter month and year, or year.

Date Given

If the exact date is unknown, please enter month and year, or year.

Dose 1

Dose 2

Vaccination Facility

Additional Patient Information

Complete only for U.S military / Department of Defense (DoD) related reports

Dose 1

Dose 2

Event Information

Please list individual adverse events using the Add Event button.

If the Adverse Event information reported exceeds the number of characters, please include the remaining information in the free text box (Medication & Event Relationship) section below.

Dates this event occurred

Start Date

If the exact date is unknown, please enter month and year, or year.

End Date

If the exact date is unknown, please enter month and year, or year.

Event Duration

This field is required

Select applicable criteria for this event

Select all that apply, leave blank if none are applicable

Pour les Collaborateurs AstraZeneca / Prestataires AstraZeneca:

sélectionner si applicable le ou les critère(s) de gravité tel que rapporté par le notificateur, sans interprétation de votre part.

Sélectionner tous les critères applicables (laisser vide si non applicable)

May require medical or surgical intervention to prevent death, disability, congenital anomaly or birth defect.

Death details

Date of Death

If the exact date is unknown, please enter month and year, or year.

Hospitalisation

Admission date

If the exact date is unknown, please enter month and year, or year.

Discharge date

If the exact date is unknown, please enter month and year, or year.

Medication & Event Relationship

Please provide details if you think any medication / device and an adverse event are associated.

Please change on the Product page if this is incorrect

Please select an option

Please select an option

Which adverse event(s) do you think is associated to this medication / device?*

Your Medical Question

Date due to customer

Product Quality Complaint

Expiration Date

Fast Track investigations are reserved for extremely serious PQCs that have the potential to cause risk to patients and / or required rapid notification to regulatory authorities.

Defect start date

- A description of the circumstances that led to the discovery of the product defect.

- How long have you experienced the issue with the product?

- If use or user error relates to the Product Quality Complaint.

If sample is available, please retain the sample for 21 days from today. AstraZeneca may request the sample as part of our investigation.

Address to where the sample return mailer will be sent

Please help us in understanding the details of your complaint by answering the following questions*

Appearance, Packaging

Appearance, Device

Appearance, Drug

Warm Product

Missing Pack Item

Needle Damage/Malfunction

Activation prior to injection at cap removal

Activation prior to opening carton

Activation prior to injection, other

Slow Injection

Medication expels while holding down the device

Device lifts up or is lifted up before injection is complete

Injection starts or continues after lifting up device

Unable to insert needle into the skin

Medication observed at injection site after lifting up

No Click Heard

Device Appearance, Cosmetic damage

Device Appearance, Foreign Matter

Device Appearance, Plunger Rod, Stopper, Needle Guard, Syringe, Finger Flange, Needle Cover

Attachment/Detachment Issue Plunger Rod/Stopper

Attachment/Detachment Issue Syringe Plunger Rod back out

Attachment/Detachment Issue Needle Cover

Attachment/Detachment Issue Needle Cover

Attachment/Detachment Issue Finger Flange

Attachment/Detachment Issue Needle Guard

B/M/D Plunger Rod

B/M/D Finger Flange

B/M/D Needle Guard

B/M/D Needle Cover

B/M/D Stopper

B/M/D Syringe

Device doesn’t function

Incorrect Dosing administered: Incorrect Dose

Incorrect Dosing administered: Incomplete dose

Device Label Missing/Damaged: Missing Label

Device Label Missing/Damaged: Unreadable Label

Device Label Missing/Damaged: Flawed Label

Device Label Missing/Damaged: Damaged Label

Fluid present after use

Fluid present during set up

Fluid present from a component: Needle Cover

Fluid present from a component: Syringe

Fluid present from a component: Stopper

Fluid present from a component: Unspecified

Device Missing Item/Needle Cover

Device Missing Item/Plunger Rod

Device Missing Item/Needle Guard

Device Missing Item/Finger Flange

Device Missing Item/Syringe

Needle Cover Damage

Needle Cover Difficult to Remove

Needle Clogged

Damaged Needle/Unspecified

Damaged Needle/Dull

Damaged Needle/Bent

Damaged Needle/Tip flat or not beveled

Damaged Needle/Needle detached/broke off

Damaged Needle/Needle missing

Needle Guard deployed early/ during carton opening

Needle Guard deployed early/ upon arrival

Needle Guard deployed early/removal from package

Needle Guard deployed early/removal of Needle Cover

Needle Guard deployed late

Needle Guard undeployed

Unable to administer/No dose

Unable to administer/No drug coming out

Pack Broken/Malformed/Damaged- Carton

Pack Broken/Malformed/Damaged- TES

Broken/Malformed/Damaged- Tray

Pack Broken/Malformed/Damaged- Carton Dirty

Foreign Matter in the packaging

Instructions Difficult to Understand

Literature Missing/Damaged: Missing Literature

Literature Missing/Damaged: Damaged Literature

Missing Text/IFU

Incorrect text/IFU

Missing Text/PI

Incorrect text/PI

Pack Artwork:Missing Text/Carton

Pack Artwork:Incorrect text/Carton

Missing Pack Item/APFS

Missing Pack Item/Tray

Pack Mix Up/Lot numbers

Pack Mix Up/Lliterature

Pack Printing/Flawed text

Pack Printing/missing text

Pack Printing/unreadable text

Product Appearance/Air Bubbles

Product Appearance/Cloudiness

Product Appearance/Discoloration

Consistency/Solubility

Foreign matter inside the syringe

Different/wrong looking APFS

Incorrect color of Plunger Rod

Incorrect color of Needle Guard

Incorrect color of Finger Flange

Different/wrong looking APFS

Different/wrong looking APFS

Different/wrong looking APFS

Odor/Taste/Drug

Odor/Taste/Package Components

Pack/Other

Medical/Adverse Event

Medical/Product Tag Alert

Appearance, Packaging

Appearance, Device

Appearance, Drug

Warm Product

Missing Pack Item

Needle Damage/Malfunction

Activation prior to injection at cap removal

Activation prior to opening carton

Activation prior to injection, other

Slow Injection

Medication expels while holding down the device

Device lifts up or is lifted up before injection is complete

Injection starts or continues after lifting up device

Unable to insert needle into the skin

Medication observed at injection site after lifting up

No Click Heard

Device Appearance, Cosmetic damage

Device Appearance, Foreign Matter

Device Appearance, Plunger Rod, Stopper, Needle Guard, Syringe, Finger Flange, Needle Cover

Attachment/Detachment Issue Plunger Rod/Stopper

Attachment/Detachment Issue Syringe Plunger Rod back out

Attachment/Detachment Issue Needle Cover

Attachment/Detachment Issue Needle Cover

Attachment/Detachment Issue Finger Flange

Attachment/Detachment Issue Needle Guard

B/M/D Plunger Rod

B/M/D Finger Flange

B/M/D Needle Guard

B/M/D Needle Cover

B/M/D Stopper

B/M/D Syringe

Device doesn’t function

Incorrect Dosing administered: Incorrect Dose

Incorrect Dosing administered: Incomplete dose

Device Label Missing/Damaged: Missing Label

Device Label Missing/Damaged: Unreadable Label

Device Label Missing/Damaged: Flawed Label

Device Label Missing/Damaged: Damaged Label

Fluid present after use

Fluid present during set up

Fluid present from a component: Needle Cover

Fluid present from a component: Syringe

Fluid present from a component: Stopper

Fluid present from a component: Unspecified

Device Missing Item/Needle Cover

Device Missing Item/Plunger Rod

Device Missing Item/Needle Guard

Device Missing Item/Finger Flange

Device Missing Item/Syringe

Needle Cover Damage

Needle Cover Difficult to Remove

Needle Clogged

Damaged Needle/Unspecified

Damaged Needle/Dull

Damaged Needle/Bent

Damaged Needle/Tip flat or not beveled

Damaged Needle/Needle detached/broke off

Damaged Needle/Needle missing

Needle Guard deployed early/ during carton opening

Needle Guard deployed early/ upon arrival

Needle Guard deployed early/removal from package

Needle Guard deployed early/removal of Needle Cover

Needle Guard deployed late

Needle Guard undeployed

Unable to administer/No dose

Unable to administer/No drug coming out

Pack Broken/Malformed/Damaged- Carton

Pack Broken/Malformed/Damaged- TES

Broken/Malformed/Damaged- Tray

Pack Broken/Malformed/Damaged- Carton Dirty

Foreign Matter in the packaging

Instructions Difficult to Understand

Literature Missing/Damaged: Missing Literature

Literature Missing/Damaged: Damaged Literature

Missing Text/IFU

Incorrect text/IFU

Missing Text/PI

Incorrect text/PI

Pack Artwork:Missing Text/Carton

Pack Artwork:Incorrect text/Carton

Missing Pack Item/APFS

Missing Pack Item/Tray

Pack Mix Up/Lot numbers

Pack Mix Up/Lliterature

Pack Printing/Flawed text

Pack Printing/missing text

Pack Printing/unreadable text

Product Appearance/Air Bubbles

Product Appearance/Cloudiness

Product Appearance/Discoloration

Consistency/Solubility

Foreign matter inside the syringe

Different/wrong looking APFS

Incorrect color of Plunger Rod

Incorrect color of Needle Guard

Incorrect color of Finger Flange

Different/wrong looking APFS

Different/wrong looking APFS

Different/wrong looking APFS

Odor/Taste/Drug

Odor/Taste/Package Components

Pack/Other

Medical/Adverse Event

Medical/Product Tag Alert

Appearance, Packaging

Appearance, Device

Appearance, Drug

Warm Product

Missing Pack Item

Needle Damage/Malfunction

Activation prior to injection at cap removal

Activation prior to opening carton

Activation prior to injection, other

Slow Injection

Medication expels while holding down the device

Device lifts up or is lifted up before injection is complete

Injection starts or continues after lifting up device

Unable to insert needle into the skin

Medication observed at injection site after lifting up

No Click Heard

Appearance, Packaging

Appearance, Device

Appearance, Drug

Warm Product

Missing Pack Item

Needle Damage/Malfunction

Activation prior to injection at cap removal

Activation prior to opening carton

Activation prior to injection, other

Slow Injection

Medication expels while holding down the device

Device lifts up or is lifted up before injection is complete

Injection starts or continues after lifting up device

Unable to insert needle into the skin

Medication observed at injection site after lifting up

No Click Heard

Thank you for helping us to better understand the details.

Please provide information about the defect in the "Tell us about your complaint" section.

What address can the PQC acknowledgement letter be sent to?

If the reporter has given consent to be contacted, AstraZeneca may reach out to the reporter to request further information through an encrypted email sent via the Mimecast tool.