Severe infection added as angioedema and an identified risk urticarial> Convulsions added as a potential risk> Part VII: Annexes Annex 1 EudraVigilance Interface – Available in electronic format only Annex 2 Treatment protocol – Provide copies of the treatment protocol. Annex 3 - Worldwide marketing authorisation by country (including EEA) For each product in the RMP provide (only if applicable): A3.1 Licensing status in the EEA Country Current licence Date of Date first Brand Comments status licence marketed in name(s) action 1 country Choose one of the <Enter a <Enter a date> If product has following: date> different routes of Approved authorisation e.g. Refused national + MRP in review
Severe infection added as an identified risk Convulsions added as a potential risk> angioedema and urticarial> Part VII: Annexes Annex 1 – EudraVigilance Interface Available in electronic format only Annex 2 – Treatment protocol Provide copies of the treatment protocol. Annex 3 - Worldwide marketing authorisation by country (including EEA) For each product in the RMP provide (only if applicable): A3.1 Licensing status in the EEA Country Current licence status Date of licence action 1 Date first marketed in country Brand name(s) Comments Choose one of the following: Approved Refused review <Enter a date> <Enter a date> If product has different routes of authorisation e.g. national + MRP in
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