In Section 2, Qualitative and quantitative composition, sodium content is corrected to 76 mg

In Section 4.4, Special warnings and precautions for use, the following text is added -

Infections

In a phase 2 clinical trial investigating necitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone as the first­‑line therapy in patients with Stage IV metastatic squamous NSCLC, an increased rate of infections was observed early after start of treatment, which led to subsequent infectious complications such as pneumonia and/or sepsis.  A similar observation was made in a clinical trial investigating necitumumab in combination with pemetrexed and cisplatin versus pemetrexed and cisplatin alone as the first‑line therapy in patients with advanced non‑squamous NSCLC.

Special attention should be given to patients with clinical evidence of concomitant infectious conditions including early signs of active infections.  Treatment of any infection should be initiated according to local standards.

In Section 5, Pharmacodynamic properties, the following text is added -

In a phase 2 clinical trial investigating necitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone (106 versus 55 patients, 2:1 randomisation) as the first line therapy in patients with Stage IV metastatic squamous NSCLC, a higher rate of death, including death due to infection, was observed for the necitumumab plus paclitaxel/carboplatin arm during the first 4 months (see also section 4.4), with a later trend towards improved survival after 4 months.  The overall survival hazard ratio [HR] was 0.83 [0.55, 1.52].

In Section 10, The date of revision of the text is updated to 10 November 2016