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Medicine Compliance Aid Stability

Zovirax · GlaxoSmithKline UK

GlaxoSmithKline UK
Tablets dispersible 200mg, 800mg
R1 · Red 1 · Stability data indicates that the drug is not suitable for CAs.
Store in airtight containers. Protect from light and moisture. Disintegrates outside packaging
29th July 2015

generic · Actavis UK Ltd

Actavis UK Ltd
Tablets 200mg, 400mg, 800mg
A3 · Amber 3 · No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Airtight container
Protect from light
Protect from moisture
Store in airtight containers. Protect from light and moisture
18th August 2015

Lactation Safety Information

Oral / Intravenous

Oral / Intravenous
Small amounts in breast milk
Used in full-term neonates from birth
Moderate level of evidence of use in breastfeeding
Poor oral bioavailability

For ophthalmic use

For ophthalmic use
Eye ointment discontinued globally December 2018
15th September 2019

For topical use

For topical use

New Medicines

Sitavig · Recurrent orofacial herpes simplex in immunocompetent patients


New formulation

Development and Regulatory status

Licensed but not launched
Jan 19 · Sitavig was launched in France in 2018, but no details are available yet regarding launch in other EU countries [12].
Jul 17 · Onxeo divests Sitavig to Vectans Pharma. Vectans Pharma specialises in commercialisation of drugs for oral pathologies [11].
May 16 · Bruno Farmaceutici will launch Labiriad® (name of Sitavig® in Italy) under its current regulatory status (prescription) and manage the regulatory procedure to obtain an over-the-counter (OTC) designation [10].
May 16 · Onxeo states on its website that Sitavig is to be marketed by international partners, mainly via licensing agreements, contributing towards the funding of other development projects [8].
Jul 15 · Onxeo sign a license agreement for Sitavig® with specialty pharmaceutical company Bruno Farmaceutici for commercialisation in Italy [8].
Aug 14 · BioAlliance Pharma merges with TopoTarget to form Onxeo [7].
Apr 13 · Sitavig® approved in US for treatment of recurring Herpes labialis [4].
Apr 13 · The first 8 EU countries in which Sitavig was approved include Sweden, the UK, Spain, Italy, Denmark, Finland, Norway & Poland. BioAlliance Pharma planned to submit registration dossiers in other European countries as soon as the 1Q 2013. The evaluation by the agencies should then last 4 to 6 months [5].
Feb 13 · Approved in the UK [6].
Dec 12 · Recommended for approval for treatment of recurrent labial herpes in immunocompetent pts presenting with more than four episodes a year, in 8 European countries including the UK, following a decentralised prcedure with Sweden as the refererence member state [3].
May 12 · US FDA has accepted the registration dossier for Sitavig (Sitavir) [2].
May 12 · US FDA has registration dossier for Sitavig (Sitavir). FDA has 60 days to conduct preliminary review and confirm validity for substantial review. Dossier is based on results of pivotal PIII clinical trial. [2]
Oct 11 · Filed in EU [1].


DNA polymerase inhibitor
According to a survey in 2000 patients, more than 33% suffered recurrent herpes (4 episodes and more a year) with an annual average of 6.3 episodes. [1]
Recurrent orofacial herpes simplex in immunocompetent patients

Trial or other data

Oct 11 · The EU filing is based on results PIII trial in 775 patients where one single application of Sitavir® 50mg significantly reduced the occurrence of vesicular lesions (p=0.043), the duration of the herpes episode (p=0.0038) and the severity of symptoms (p=0.008). A 9-month follow-up showed that Sitavir® had an effect on the long term, delaying the time to occurrence of the following herpes episode (p=0.04). [1]
Oct 11 · Mucoadhesive buccal tablet delivering very high concentrations of the active ingredient in mucosa and lips.