2023

Professional development Vacancies
2023
Changes to the safety information of medicinal products containing olaparib, adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) during the signal review at the meeting in 3-6 July 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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Scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency and the grounds for amending the registration materials/instructions for medical use of medicinal products containing dexamethasone

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 lamotrigine (lamotrigine)

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 flurbiprofen (flurbiprofen)

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 apomorphine (apomorphine)

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 morphine

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 semaglutide following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of January 9-12, 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 of medicinal products containing vemurafenib (vemurafenib) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 11-14 April 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 of medicinal products containing pralsetinib (pralsetinib) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 11-14 April 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 of medicinal products containing pralsetinib (pralsetinib) following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 11-14 April 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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