Side-effect reporting form

If you wish to advise Actelion of any side-effects that takes place, please do not hesitate to use this form.

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product. This untoward medical occurrence does not necessarily imply a causal relationship with the particular treatment and includes the following:

Lack of efficacy
Suspected transmission of an infectious agent via a product
Overdose, misuse or medication errors
Pregnancy/lactation when using a product (whether or not associated with an adverse event)
Drug-drug interactions

Form for patients

The fields marked with a * are mandatory.

Reporter (Your) Details

Title

Mr Ms Mrs Miss

First name*

Surname*

E-mail*

Telephone

Address

Address 2

Town

Postcode

Country*

Relationship to patient*

Patient Details (person who experienced the adverse event)

Initials only (name, surname)*

Date of birth or Age*

Gender

Male Female

Pharmaceutical product details

Name of medicine*

What it is used for

Dosage*

When was the medicine started?

When was the medicine stopped?

Other medicines

About the adverse event

Adverse event description*

When did the adverse event start?*

Has the adverse event stopped?*

Yes No Unknown

If Yes, on what date?

How bad was the adverse event?

1.Mild 2.Moderate 3.Severe

How is the adverse event now?

1.Mild 2.Moderate 3.Severe

Did you/the patient receive any treatment, and did the adverse event cause you/the patient to stop taking the medicine.*

Other questions

Was a doctor, pharmacist or other health professional told about the adverse event?*

Yes No Unknown

Are you happy for Actelion to contact you for more information?

Yes No

Are you happy for Actelion to contact your Doctor or GP for more information?

Yes No

Please enter the name and address of your Doctor or GP surgery?*

Privacy

<p>We will use your information in accordance with our <a href="/system/legal/privacy-policy">Privacy Policy</a> to respond to your inquiries and fulfill your requests as necessary for our legitimate interest and possibly to comply with our legal obligations relating to pharmacovigilance or product quality. Please read our <a href="/system/legal/privacy-policy">Privacy Policy</a>.</p> <p>Your information will be transferred to countries outside of your country of residence, including the United States, which may provide for different data protection rules than in your country.</p>

I AGREE

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Side-effect reporting form

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Side-effect reporting form

Form for patients

Contact overview