Please complete and forward this form within 24 hours of becoming aware of the pregnancy/event to:

Biotest Schweiz AG, Drug Safety Officer (DSO/PvP), Schützenstrasse 17, CH-5102 Rupperswil,

Tel: +41 62 889 00 00, Fax: +41 62 889 00 01 or uaw.ch@biotest.com

Data protection: Privacy notices related to personal data collected on this form can be found

on the Biotest (Schweiz) AG website (https://www.biotest.com/ch/) under ‘Datenschutz’.

Reporter name
Address
E-Mail
Phone number
If you are a healthcare professional, please enter your qualification: Midwife Gynecologist Pediatrician Mother / Father Other, please specify:

Part 1: Pregnancy
Biotest Product Information
Product name	Reason for treatment	Batch number
Date of first administration (DDMMMYYYY):	Date of last administration (DDMMMYYYY):	Therapy with Biotest products was applied to: Mother Father
Information on mother
Initials:	Age:	Height (cm)	Weight (kg)
Last menstruation (DDMMMYYYY)	Estimated date of delivery (DDMMMYYYY)
Is the pregnancy ongoing? No (If no, please fill out part 2.) Yes

Part 2: Outcome of pregnancy
Follow-up report. To be filled out at the end of the pregnancy. If the child experienced an adverse event (AE), please fill out Part 3. In situations when the mother experienced an AE, miscarriage/stillbirth, spontaneous abortion, delivery complications or abnormal placenta, please fill out the regular Biotest "Report of Suspected Drug Reaction (ADR)" form, which can be downloaded on the Biotest website under Contact’ and ‘Reporting suspected adverse reactions'.
Singleton Multiples (Please complete a report for each child)
Delivery
Date of delivery (DDMMMYYYY):	Mode of delivery: Vaginal delivery Caesarean section
Delivery complications No Yes (if yes, please fill out ADR form)	Abnormal placenta (including ectopic pregnancy) No Yes (if yes, please fill out ADR form)
Elective termination, please specify the reason:
Premature birth in gestation week
Miscarriage in gestation week, please continue with part 3.
Infant status
male female diverse	Birth weight (kg)	Birth height (cm)	APGAR score:
Healthy baby	Malformation / Abnormities (please specify in Part 3)	Other adverse event (please specify in Part 3)

Part 3: Adverse event(s) of baby
Adverse event (AE)
Short description of event, including relevant information, symptoms, possible misuse / interaction, etc.
AE 1:	Treated with:
Start date of event (DDMMMYYYY):	Duration of event:	Outcome: recovered / resolved, on (DDMMMYYYY): recovering / resolving not recovered / not resolved resolved with sequelae fatal Unknown
Causal relationship with drug? No Yes
AE 2:	Treated with:
Start date of event (DDMMMYYYY):	Duration of event:	Outcome: recovered / resolved, on (DDMMMYYYY): recovering / resolving not recovered / not resolved resolved with sequelae fatal Unknown
Causal relationship with drug? No Yes
Relevant Medical and Drug History of Mother
Allergies	No Yes	If yes, please specify:
IgA-Deficiency	No Yes	If yes, please specify:
Risk factors: Smoking Alcohol abuse Drug abuse
Other relevant medical history	Start date (DDMMMYYYY)	End date (DDMMMYYYY)	Continuing?
No Yes
No Yes
Any other medication used (during pregnancy)?
No Unknown
Product	Daily dose	Route	Date / duration of treatment	Reason for treatment (Disease)
Previous Pregnancies
No Yes (please specify)
Date of delivery (DDMMMYYYY)	Gestational week at delivery	Outcome	Other complications
Healthy baby Miscarriage Fetal/neonatal abnormities
Healthy baby Miscarriage Fetal/neonatal abnormities
Relevant medical history of father
Relevant medical history	Start Date (DDMMMYYYY)	End Date (DDMMMYYYY)	Continuing?
No Yes
No Yes
Other concomitant medication at time of conception
No Unknown
Product	Daily dose	Route	Date / duration of treatment	Reason for treatment (Disease)

The local health authority was notified	No Yes	If yes, state which authority?:

SIGNATURE	DATE

THANK YOU FOR TAKING THE TIME TO COMPLETE THIS FORM.