SmPC- Buprenorphine 8mg Sublingual Tablets: Change history
View Summary of Product Characteristics (SmPC- Buprenorphine 8mg Sublingual Tablets)
Last updated on this site: 05 Nov 2024
To update sections 4.2, 4.4, 4.5, and 4.8 of the SmPC in line
with PRAC recommendation (EMEA/H/C/PSUSA/00000459/202309). Consequently, the PIL
has been updated.
Additional updates:
Update to SmPC section 4.4 to correct the medicinal name.
Formatting updates to SmPC sections 4.2, 4.8 and PIL.
Editorial updates to SmPC sections 4.4, 4.8 and PIL.
QRD updates to SmPC section 4.8.
Last updated on this site: 05 Nov 2024
To update sections 4.2, 4.4, 4.5, and 4.8 of the SmPC in line
with PRAC recommendation (EMEA/H/C/PSUSA/00000459/202309). Consequently, the PIL
has been updated.
Additional updates:
Update to SmPC section 4.4 to correct the medicinal name.
Formatting updates to SmPC sections 4.2, 4.8 and PIL.
Editorial updates to SmPC sections 4.4, 4.8 and PIL.
QRD updates to SmPC section 4.8.
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Changes: (Updated: 05 Nov 2024)
To update sections 4.2, 4.4, 4.5, and 4.8 of the SmPC in line
with PRAC recommendation (EMEA/H/C/PSUSA/00000459/202309). Consequently, the PIL
has been updated.
Additional updates:
Update to SmPC section 4.4 to correct the medicinal name.
Formatting updates to SmPC sections 4.2, 4.8 and PIL.
Editorial updates to SmPC sections 4.4, 4.8 and PIL.
QRD updates to SmPC section 4.8.
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Changes: (Updated: 20 Sep 2022)
Initial upload