ADVERSE DRUG REACTION REPORTING FORM

Fill in a form for the health care professional

ADVERSE REACTION REPORTING FORM

Fill in a form for non- healthcare professional

The following form should be completed by the healthcare professional. If you are a patient, his guardian or representative go to the form intended for you.

Fields marked with an asterisk (*) are required.

Report:

Patient information

Sex *:

Type of the reaction *:

Adverse reaction occurred in patients treated:

Outcome:

Is there a causal link between adverse reaction and drug used:

Product(s) Information Suspected of Causing Adverse Reactions:

2nd product details:

3rd product details:

4th product details:

5th product details:

Is the adverse reaction abated after discontinuation of the medicinal product?

Is the adverse reaction reappeared after reintroduction of the drug?

Concomitant medicinal products and additional information:

Other medicinal products used and the start and end dates of administration, indications, doses that were used at the same time as the drug (s) suspected of causing adverse reactions (exclude those used to treat adverse reaction)

2nd product details:

3rd product details:

4th product details:

5th product details:

Other past or concurrent illness / other medically relevant information (e.g. diagnostics, allergies, genetics or family conditions).

Details of the person reporting:

*Qualifications of reporting person:

All the information and personal data you share with us in your adverse drug reaction notification will be protected and kept confidential in line with COMPANY POLICY and local regulations.

The information you provide will be used for the purpose of drug safety surveillance [and to enable us to deal with your notification appropriately] and it may be shared with health authorities if such obligation results from provisions of law.

You have a right of access to and to rectify your personal data which we hold about you.

Providing data marked with * is obligatory, under Art. 36e of the Act of 6 September 2001. - Pharmaceutical Law. Providing other data is voluntary.

Contact data of reporting person:

Providing the following information is not mandatory but it could facilitate the analysis of adverse reaction reported by you, if the contact to obtain additional information is required.

Contact details of the person reporting: