Individual Case Safety Report (Icsr) Form

INDIVIDUAL CASE SAFETY REPORT (ICSR) FORM
Please send the filled form to the PV department:

E-Mail:
Telephone:
Submit form
Reporter information:
First name Last name Title Occupation/Specialty
Street Zip code City Country
Hospital/Organization Name Telephone No. E-Mail address
Patient information:
Female Yes
years Male No
Initials Date of birth Age at time of event Gender Pregnancy
(first name, last name)
Marketed product (please complete one report for each SIT administration that led to AE):
Marketed product name Allergen/bacterial composition

Product withdrawn
Dose reduced
Indication for use Dose increased
Action taken Dose not changed
with product: Unknown
Date of administration Reference number
Vial 0 Vial 1 Vial 2 Vial 3
Vial A Vial B
Event occurred at a dose of: mL/pumps/drops from Not applicable
Concomitant medication (please list all medication that the patient receives concomitantly) Not applicable
Route of
Name of concomitant drug Indication Dose Start date End date
administration
1.
2.
3.
Description and assessment of event(s):

Latency Event
Event(s) in Event(s) in Serious Event Event Causal
(A) period duration Intensity(B) Outcome(C)
native language English start date end date relationship(D)
(with unit) (with unit)
1.
2.
3.
4.
5.
In printed version, please select:

(A) please select: yes, no
(B) please select: mild, moderate, severe, unknown, not applicable
(C) please select: recovered/resolved, recovering/resolving, not recovered/not resolved, recovered with sequelae, fatal, unknown, not applicable
(D) please select: certain, probable, possible, unlikely, unrelated, unclassifiable, unknown, not applicable
PVR-02, vX Appendix I, vY
INDIVIDUAL CASE SAFETY REPORT (ICSR) FORM
Treatment of event(s) required? If yes, please describe treatment (name, dose, duration, etc.):
Yes No Unknown
Not applicable
Seriousness (if you have marked any of the above reactions as serious, please specify your choice):
Results in persistent or significant disability/incapacity
Patient died due to event
Is a congenital anomaly / birth defect
Is life threatening
(The term "life-threatening" in the definition of "serious" refers to Other medically important condition (please explain your medical judgement):
an event in which the patient was at risk of death at the time of the
event; it does not refer to an event which hypothetically might have
caused death if it were more severe. cf.ICH Topic E2A)
Caused/prolonged hospitalization Inpatient hospitalization without treatment Inpatient hospitalization with treatment
Hospitalization from: Hospitalization to:
Additional information (please include all relevant information including co-diseases, co-medications, diagnosis and any
additional information; if the space is not sufficient, please feel free to use a separate sheet of paper) Not applicable
Yes
Was any (health) Name of informed Date when authority was
No
authority informed? authority: informed:
Unknown
Date of this report Form completed by (name) Signature
Personal Data Protection: ALLERGY THERAPEUTICS IBERICA S.L.U./B62034988/ Avda. De Barcelona, 115, ed. Brasol, 2nd Floor, 08970 Sant Joan Despí (Barcelona);
email: [email protected]; informs that the data included in this form will be processed in order to attend, manage and monitor the Pharmacovigilance of our
products, specifically the completion of the Individual Case Safety Report (ICSR form). The basis of legitimacy of the treatment is the fulfillment of the legal obligations. We
inform you that your data may be communicated to the European Medicines Agency (EMA) and the Spanish Agency for Medicines and Health Products (AEMPS), in compli-
ance with RD 577/2013 that regulates the Pharmacovigilance of medicinal products for human use. This information will be kept during the minimum periods established in
the regulations applicable to Pharmacovigilance and during the prescription period of possible responsibilities. You can exercise your rights of access, rectification, deletion,
portability and limitation or opposition by writing to the above address.You can also claim to the Control Authority (Spanish Agency for Data Protection www.aepd.es). You
can contact our Data Protection Officer at: [email protected]
Only for internal processing at Allergy Therapeutics.

Not required to be completed by reporter. To be completed by first receiver in the name of AT (e.g. Sales representative, etc.)
First name of first receiver in the name of AT Last name of first receiver in the name of AT Date of receipt by first receiver
Contact details of first

receiver in name of AT
Phone E-Mail
To be completed by LSO
LSO Name LSO received report on Duplicate check by Duplicate check on Local case number
Report type Description (e.g. NIS number, literature reference, etc.)
Yes No Not applicable
The case is to be submitted to your local Reason for submission to local HCA Submission due date to your
health care authority (HCA) local HCA
PVR-02, vX Appendix I, vY

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Individual Case Safety Report (Icsr) Form

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Available Formats

INDIVIDUAL CASE SAFETY REPORT (ICSR) FORM

Please send the filled form to the PV department:

First name Last name Title Occupation/Specialty

Street Zip code City Country

Hospital/Organization Name Telephone No. E-Mail address

Marketed product name Allergen/bacterial composition

Description and assessment of event(s):

In printed version, please select:

Hospitalization from: Hospitalization to:

Date of this report Form completed by (name) Signature

Only for internal processing at Allergy Therapeutics.

Contact details of first

Report type Description (e.g. NIS number, literature reference, etc.)

Yes No Not applicable

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