Summary of Revisions: The revisions to EU QRD included all changes related to rrMCL and ECHO (TN-MCL) indications.

SmPC Section 4.1

• rrMCL and ECHO (TN-MCL) new indications

SmPC Section 4.2

• Information related to the posology of the ABR combination and toxicities management.

SmPC Section 4.4

• EMA considered TLS and pneumonitis/ILD events reported with Calquence therapy warranted the inclusion of a special warning for both TLS and ILS events.

SmPC Section 4.8

• Revised according to the updated monotherapy pool and ABR combination.

SmPC Section 5.1

• Updated according to rrMCL (ACE-LY-004) and ECHO (ACE-LY-308) clinical trial efficacy data

PIL updated following approval of rrMCL and Echo indication updates. NI details removed from reporting details.

4.      Possible side effects

[...]

Very common (may affect more than 1 in 10 people):

·      muscle or joint pain

·      headache

·      rash

·      feeling tired (fatigue), weakness or lack of energy

·      feeling sick to your stomach (nausea),vomiting, stomach pain, constipation (infrequent or hard to pass stool), diarrhoea (frequent or loose stools)

·      decreased number of red blood cells, decreased number of neutrophils (a type of white blood cells) or decreased number of cells that help blood clot (platelets).)

·      high blood pressure

·      dizziness

·      headache, pressure in the eyes, nose or cheek area (sinusitis)

·      sore throat and runny nose (nasopharyngitis)

·      upper respiratory tract infection

·      urinary tract infection (pain or burning feeling when passing urine).)

·      new cancers, including cancers of the skin, may happen during treatment with Calquence (see section 2 ‘What you need to know before you take Calquence’)

[...]

6.      Contents of the pack and other information

[...]

This leaflet was last revised in 0408/2023.

Addition of Hypertension as an ADR to section 4.8, table 3 and table 4

10.    DATE OF REVISION OF THE TEXT

14^th June16 August 2023

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