• In section 4.4, the following paragraph has been amended:

Traceability

In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded (or stated) in the patient file.

• In section 4.7, the following paragraph has been amended:  Trastuzumab may have a minor influence on the ability to drive or use machines (see section 4.8). Patients experiencing infusion-related symptoms (see section 4.4) should be advised not to drive and use machines until symptoms abate.

• In Section 4.8 (undesirable effects), the following paragraph has been amended:

Immunogenicity

In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of patients treated with trastuzumab intravenous developed antibodies against trastuzumab. Neutralising anti-trastuzumab antibodies were detected in post-baseline samples in 2 of 30 patients in the trastuzumab intravenous arm.

The clinical relevance of these antibodies is not known. The presence of anti-trastuzumab antibodies had no impact on the pharmacokinetics, efficacy (determined by pathological complete response [pCR] and event free survival [EFS]) and safety determined by occurrence of administration related reactions (ARRs) of trastuzumab intravenous.

• In Section 10, the date of revision has been amended to September 2018

• In section 6.3, the shelf-life has been changed from 30 months to 3 years
• In section 10, the date of revision has been updated to 20 July 2018