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歡迎來到 AstraZeneca 阿斯特捷利康

您可以使用此網站通報阿斯特捷利康、Alexion及其他阿斯特捷利康產品的不良事件或產品品質投訴,具體內容請參見網站中包含的隱私通知。您也可以請求關於上述產品的醫藥諮詢。

如果您要通報藥物不良事件或產品品質申訴,請選擇事件發生的國家/地區,無論您目前身在何處。

我們能提供什麼協助?

勾選所有適用的項目

藥物的不良反應有時被稱為副作用,為使用藥物或醫療器材之後,意外發生或預期外的事件或反應。

醫藥資訊查詢是與本公司藥物或醫藥器材相關的醫藥或科學性問題的查詢。

產品品質申訴與藥品本身、或其醫療器材、或其包裝相關的問題。

請選擇一個選項

通報藥物不良反應事件

藥物不良事件有時稱作為副作用,是不想要、或非預期的事件、或是對藥物的反應。

詢問醫藥資訊

醫藥資訊查詢是與本公司藥物或醫藥器材相關的醫藥或科學性問題的查詢。

通報產品品質申訴

產品品質申訴與藥品本身、或其醫療器材、或其包裝相關的問題。

哪一個最能描述您?

我是一個...

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

(勾選該選項前,請務必確認您通報的不良事件發生於阿斯特捷利康早期准入計畫(EAP),單個患者同情用藥(SiPCU),試驗後准入(PTA)或藥品國際准入計畫(GATM))

AstraZeneca Medical

病人資訊

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

Required by the health authorities.

阿斯利康提供的項目編號。 針對EAP和PTA,可提供D code或阿斯利康提供的其他編號; 如報告來自SiPCU,請備註“SiPCU”; 來自GATM,請備註“GATM”。 如不確定,請聯系您的阿斯利康聯絡人。

發生不良事件特定患者的識別編號。 如不確定,請聯系您的阿斯利康連絡人。

聯絡資訊

個人資訊

如果確切的日期不明,請輸入月份和年份或年份。

身高

體重

身高

體重

最後月經日期
到期日

通報者資訊

您是與醫護人員聯繫的代表,請提供您的詳細資料。

醫護人員

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

Required by the health authorities.

聯絡資訊

照顧者

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

Required by the health authorities.

聯絡資訊

您的資訊

哪一個最能描述您在阿斯特捷利康的角色?

我是一個...

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

AZ初始獲知日期 *

請 ODCP 供應商在此處錄入患者ID或供應商參考ID。請明確説明提供的是患者ID還是供應商參考ID,具體如下:"Pat ID:[xxx]" 或 "Ref ID:[yyy]";並確保輸入內容不超過 20 個字元。如果同時提供兩個 ID,請僅在自由文本框(其他相關信息-用藥&事件關繫部分)中填冩,如下所示:"Pat ID:[xxx]; Ref ID:[yyy]"。

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]"

病人資訊

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

Required by the health authorities.

阿斯利康提供的項目編號。 針對EAP和PTA,可提供D code或阿斯利康提供的其他編號; 如報告來自SiPCU,請備註“SiPCU”; 來自GATM,請備註“GATM”。 如不確定,請聯系您的阿斯利康聯絡人。

發生不良事件特定患者的識別編號。 如不確定,請聯系您的阿斯利康連絡人。

聯絡資訊

個人資訊

如果確切的日期不明,請輸入月份和年份或年份。

身高

體重

身高

體重

最後月經日期
到期日

照顧者

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

Required by the health authorities.

聯絡資訊

通報者資訊

您是與醫護人員聯繫的代表,請提供您的詳細資料。

醫護人員

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

Required by the health authorities.

聯絡資訊

病人資訊

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

Required by the health authorities.

阿斯利康提供的項目編號。 針對EAP和PTA,可提供D code或阿斯利康提供的其他編號; 如報告來自SiPCU,請備註“SiPCU”; 來自GATM,請備註“GATM”。 如不確定,請聯系您的阿斯利康聯絡人。

發生不良事件特定患者的識別編號。 如不確定,請聯系您的阿斯利康連絡人。

聯絡資訊

個人資訊

如果確切的日期不明,請輸入月份和年份或年份。

身高

體重

身高

體重

最後月經日期
到期日

醫護人員

醫師的相關資訊

醫師的聯絡資訊

請提供至少一個聯絡方式

引起不良反應的藥品/醫療器材

請點擊「新增藥品/醫療器材」按鈕來添加藥品/醫療器材

藥品/裝置有效期限

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

開始日期

如果確切的日期不明,請輸入月份和年份或年份。

結束日期

如果確切的日期不明,請輸入月份和年份或年份。

注射疫苗的詳細情形

劑量 1

有效日期

如果確切的日期不明,請輸入月份和年份或年份。

注射日期

如果確切的日期不明,請輸入月份和年份或年份。

劑量 1

劑量 2

Vaccination Facility

Additional Patient Information

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

劑量 1

劑量 2

事件資訊

請按「新增事件」按鈕列出個別事件

如果不良事件的內容超過字數限制,請將超過部分填入下方的自由文字欄位(位於「藥物與事件的關聯」)。

此事件發生日期

開始日期

如果確切的日期不明,請輸入月份和年份或年份。

結束日期

如果確切的日期不明,請輸入月份和年份或年份。

事件持續時間

此欄位為必填欄位

選擇此事件的適用條件

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)

可能需要醫療/手術治療,以防止死亡、殘疾、先天性異常或出生缺陷。

死亡詳細資料

死亡日期

如果確切的日期不明,請輸入月份和年份或年份。

住院治療

住院日期

如果確切的日期不明,請輸入月份和年份或年份。

出院日期

如果確切的日期不明,請輸入月份和年份或年份。

藥物與事件的關連

若您認為有和藥物/醫療器材相關的任何的不良事件,請提供詳細訊息。

Please change on the Product page if this is incorrect

您認為該藥物/醫療器材與哪些不良事件相關?*

您的醫療問題

回覆期限

產品品質投訴

藥品/裝置失效日期

快速回覆調查僅適用於可能對病患造成風險和/或需要快速通報衛生主管機構的極其嚴重產品品質不良申訴。

品質不良開始的日期

請描述投訴的性質和細節,以及導致發現的情況。

您什麼時候遇到這個問題?您遇到這個問題多久了?

在使用產品前、期間或之後是否出現品質問題?

如果有樣本,請從今天起保留 21 天。 Astrazeneca 可能會要求樣本作為我們調查的一部分。

不良品寄送地址

請回答以下問題協助我們了解您投訴的詳情*

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

感謝您幫助我們更清楚地瞭解細節。

請在「告知我們您的申訴」部分提供有關品質不良的資訊

What address can the PQC acknowledgement letter be sent to?

若通報者已經同意被聯繫,AstraZeneca 可能會透過 Mimecast 發送加密郵件,以聯繫通報者獲取進一步資訊。