Exhibit I

2.8 lndividualCase Safety Report (!CSR)

synonym: Safety report
A document providing the most complete information related to an individual case at a certain point of time. An
individual case is the information provided by a primary source to describe suspected MpE(s) related to the
administration of one or more medicinal products to an individual Patient at a particular point of time.
An ICSR is considered serious if at least one of the described MpEs is serious.

2.9 Lack of efficacy

A lack of efficacy is given when the effect, qualitative as well as quantitative, a drug is intended to cause is not
observed (e.g. a drug for lowering the blood pressure does not lower the blood pressure as expected; getting
pregnancy although using a contraceptive; a bacterial infection not being controlled by the used antibiotic).

2.10 Marketing Authorisation Holder (MAH)

The MAH is the company holding marketing authorisation for a medicinal product.

2.tl MedDM
Medical Dictionary for Regulatory Affairs

2.12 Medicinalproduct
o ?ny substance or combination of substances presented as having properties for treating or preventing
disease in human beings
o any substance or combination of substances which may be used in or administered to human beings either
with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological,
immunological or metabolic action, or to making a medical diagnosis.

2.13 Medicinal Product Event (MPE)

Following situations are defined as Medicinal Product Events(MPEs):

o Untoward medical occurrence (Adverse drug event, ADE)

o Adverse drug reactions {ADR)
o Use of medicinal products during pregnancy
o Use of medicinal products during lactation (only in case of adverse reaction in the breast-fed baby)
o Lack of efficacy
o Off-label use
o Use in children if product is not registered for use in children
o Suspected transmission of infectious agents
o Overdose
o Abuse and Misuse
o Medication errors
o Adverse reactions due to occupational exposure

2.14 MinimalCriteria for MPE

Minimum information required for an MPE to be reportable to regulatory authorities is the following:
o An Identifiable reporter
The reporter can be identified by either name or initial(s), or address or qualification. The information
should be as complete as possi0le taking into account the local regulation on data protection.
o An identifiable patient
The patient can be identified either by initial(s) or patient number, or date of birth or age or age category
or sex. The information should be as complete as possible taking into account the local regulation on data
protection.
o At least one suspect active substance / medicinal product
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