Annex I Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)
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Scientific conclusions Taking into account the PRAC Assessment Report on the PSUR(s) for haemophilus type b conjugate vaccines, the scientific conclusions are as follows: Based on the number of cases received of rash generalised reported for haemophilus type b conjugate vaccines, their temporal association, and the fact hypersensitivity and rash are listed, the PRAC considers that rash generalised should be included in the tabulated list of adverse reactions in section 4.8 of the SmPC, with an unknown frequency. The package leaflet should be updated accordingly. The CMDh agrees with the scientific conclusions made by the PRAC.
Grounds for the variation to the terms of the Marketing Authorisation(s) On the basis of the scientific conclusions for haemophilus type b conjugate vaccines the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) containing haemophilus type b conjugate vaccines is unchanged subject to the proposed changes to the product information. The CMDh reaches the position that the marketing authorisation(s) of products in the scope of this single PSUR assessment should be varied. To the extent that additional medicinal products containing haemophilus type b conjugate vaccines are currently authorised in the EU or are subject to future authorisation procedures in the EU, the CMDh recommends that the concerned Member States and applicant/marketing authorisation holders take due consideration of this CMDh position.
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Annex II Amendments to the product information of the nationally authorised medicinal product(s)
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Amendments to be included in the relevant sections of the Product Information (new text underlined and in bold, deleted text strike through)
Summary of Product Characteristics •
Section 4.8
The following adverse reaction(s) should be added under the SOC Skin and subcutaneous tissue disorders with a frequency unknown: rash generalised. Package Leaflet •
Section 4
The following adverse reaction(s) should be added with a frequency unknown: rash generalised.
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Annex III Timetable for the implementation of this position
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Timetable for the implementation of this position
Adoption of CMDh position:
October 2017 CMDh meeting
Transmission to National Competent Authorities
25 November 2017
of the translations of the annexes to the position: Implementation of the position by the Member
24 January 2018
States (submission of the variation by the Marketing Authorisation Holder):
Nov 25, 2017 - The CMDh reaches the position that the marketing authorisation(s) of products in the scope of this single PSUR assessment should be varied.
Nov 25, 2017 - 4.8 of the SmPC, with an unknown frequency. The package leaflet should be updated accordingly. The CMDh agrees with the scientific conclusions made by the PRAC. Grounds for the variation to the terms of the Marketing Authorisation(s).
Sep 28, 2017 - injection Haemophilus type b and Meningococcal group C conjugate vaccine. UK/H/0954/001. PA1077/116/001. GLAXOSMITHKLINE. (IRELAND) LIMITED. IE. Menitorix, proszek i rozpuszczalnik do sporzÄ dzania roztworu do wstrzykiwaÅ. Szczepionka
European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 28 September 2017. EMA/631269/2017. Human Medicines Evaluation Division. List of nationally authorised medicinal products. Active substance: haemophilus
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