2023

Professional development Vacancies
2023
Changes to the safety information of medicinal products containing ifosfamide (ifosfamide) powder for solution for injection/infusion based on the results of the meeting of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), held on 28–30 March 2023

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

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Changes to the safety information for medicinal products containing ifosfamide in the form of solution for injection based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of October 24–27, 2022

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

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Changes to the safety information of medicinal products containing riluzole following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 29 August – 1 September 2022

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

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Changes to the safety information of medicinal products containing ustekinumab (ustekinumab) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 29 August – 1 September 2022

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

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Changes to the safety information for medicinal products containing umeclidinium bromide/vilanterol (umeclidinium bromide/vilanterol) based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of August 29 – September 1, 2022

The European Medicines Agency (EMA) has published the minutes of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 29 August – 1 September…

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Changes to the safety information of the vaccine JCOVDEN (Janssen COVID-19 Vaccine) based on the results of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting of 26-29 September 2022

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

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Regarding amendments to the instructions for medical use of medicinal products containing adenosine

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

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Changes to the safety information of medicinal products containing methotrexate (methotrexate) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 28 November – 1 December 2022

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

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Regarding amendments to the package inserts for medical use of medicinal products containing ketorolac [for systemic use]

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

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Update of safety information on medicinal products containing 3-hydroxy 3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins): atorvastatin; fluvastatin; lovastatin; pitavastatin; pravastatin; rosuvastatin; simvastatin and other relevant fixed-dose combinations, adopted by the PRAC during the review of signals discussed at the meeting of January 6-9, 2023

In accordance with paragraph 8 of Section IV of the Procedure for conducting expert evaluation, the applicant must amend the instruction for medical use of the medicinal product…

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