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Bavencio 20 mg/mL concentrate for solution for infusion

Active Ingredient:
avelumab
Company:  
Merck See contact details
ATC code: 
L01FF04
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) Risk Materials HCP Med Info
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Educational Risk Minimisation Materials to help reduce the risk associated with using this medicine.

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Bavencio 20 mg/ml concentrate for solution for infusion (avelumab) – Patient Alert Card

Proposed changes are:

• removal of the patient information brochure from the educational material, following

the PRAC assessment report PSUSA/00010635/202303

• removal of the black symbol and explanatory statements for medicinal products subject

to additional monitoring

• aligned terminology with the RMP for the term "immune-related" versus "immunemediated.

• additional editorial changes introduced by MAH.

Please find attached latest approved Patient alert card with marked changes and in clean

version.

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Merck
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Address
Merck Serono Ltd, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK
Medical Information Direct Line
+44 (0)208 818 7373
Telephone
+44 (0)208 818 7200
Fax
+44 (0)208 818 7267
Medical Information Fax
+44 (0)208 818 7274
Medical Information e-mail
[email protected]