SmPC- Ezetimibe/Simvastatin 10mg/80mg Tablets: Change history
View Summary of Product Characteristics (SmPC- Ezetimibe/Simvastatin 10mg/80mg Tablets)
Last updated on this site: 11 May 2023
Description of update: The following change(s) has been notified:
• C.I.z. Other variation. Implementation of PRAC signal recommendation [Article 5 recommendation]: "3-hydroxy 3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins): atorvastatin; fluvastatin; lovastatin; pitavastatin; pravastatin; rosuvastatin; simvastatin and other relevant fixed dose combinations; pravastatin, fenofibrate; simvastatin, fenofibrate – Myasthenia gravis", EPITT No.: 19822; here for simvastatin; SPC sections 4.4 , 4.8 and PIL sections 2, 4 [PRAC recommendations on signals adopted at the 09-12 January 2023 PRAC meeting, EMA/PRAC/4770/2023, first published 06/02/2023; national translations, EMA/PRAC/4771/2023, first published 06/02/2023].
SmPC sections updated: 4.4, 4.6, 10.
Last updated on this site: 11 May 2023
Description of update: The following change(s) has been notified:
• C.I.z. Other variation. Implementation of PRAC signal recommendation [Article 5 recommendation]: "3-hydroxy 3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins): atorvastatin; fluvastatin; lovastatin; pitavastatin; pravastatin; rosuvastatin; simvastatin and other relevant fixed dose combinations; pravastatin, fenofibrate; simvastatin, fenofibrate – Myasthenia gravis", EPITT No.: 19822; here for simvastatin; SPC sections 4.4 , 4.8 and PIL sections 2, 4 [PRAC recommendations on signals adopted at the 09-12 January 2023 PRAC meeting, EMA/PRAC/4770/2023, first published 06/02/2023; national translations, EMA/PRAC/4771/2023, first published 06/02/2023].
SmPC sections updated: 4.4, 4.6, 10.
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Changes: (Updated: 11 May 2023)
Description of update: The following change(s) has been notified:
• C.I.z. Other variation. Implementation of PRAC signal recommendation [Article 5 recommendation]: "3-hydroxy 3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins): atorvastatin; fluvastatin; lovastatin; pitavastatin; pravastatin; rosuvastatin; simvastatin and other relevant fixed dose combinations; pravastatin, fenofibrate; simvastatin, fenofibrate – Myasthenia gravis", EPITT No.: 19822; here for simvastatin; SPC sections 4.4 , 4.8 and PIL sections 2, 4 [PRAC recommendations on signals adopted at the 09-12 January 2023 PRAC meeting, EMA/PRAC/4770/2023, first published 06/02/2023; national translations, EMA/PRAC/4771/2023, first published 06/02/2023].
SmPC sections updated: 4.4, 4.6, 10.
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Changes: (Updated: 22 Mar 2023)
Initial upload. New product launch: 22/03/2023.