Individual Case Safety Report form

Report type InitialFollow-up

Reporter

Reporter’s qualification Healthcare professionalConsumer/ patient or other non-health professional

Name and surname*

email*

Phone number

Address

Patient

Country*

Sex* FemaleMale

Initials (first letter of name and surname)*

Age
(years)*

Weight
(kg)

Height
(cm)

PregnancyNoYes

Week of pregnancy

Adverse Drug Reaction(s)

Date of Start of Reaction(s)

Describe reaction(s)*

Type of treatment not applicableOutpatientHospital

Are reactions recovered YesNo

Date of recovery

Outcome recovered/resolvedrecovered/resolved with permanent sequelaenot recovered/not resolved/ongoingunknown

Seriousness criteria - Classification (if applicable)
Select if the serious adverse drug reaction resulted in: deathlife threateningrequires hospitalization/prolongation of hospitalizationpersistent or significant disability/incapacitycongenital anomaly/birth defectother medically important information

Medicinal Product(s) Information

Medicinal product name*

Select if a drug is suspected of causing undesirable effects Yes

Dosage

Route of Administration

Date of start of drug

Date of last administration

Indication(s) for use

Additional Information: e.g. previous reactions to the medicinal product, risk factors, results of additional tests

Administrator Mrs. / Mr. personal data, contained in the form and processed for correspondence are Wrocławskie Zakłady Zielarskie "Herbapol" SA. The administrator has appointed a DPO who can be contacted via e-mail: rodo@herbapol.pl or by post to the Company's address. Providing personal data is voluntary and necessary to achieve the purposes indicated in the correspondence. The content of the full information clause is available on the website