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Articles · Medicine Compliance Aid Stability · Lactation Safety Information · New Medicines ·

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Articles

Medicine Compliance Aid Stability

Celsentri · ViiV Healthcare UK Ltd

ViiV Healthcare UK Ltd
Celsentri
Tablets 150mg 300mg
A2 · Amber 2 · No stability data is available, the manufacturer does not, or cannot recommend use in CAs but there are no theoretical concerns with the product.
No special precautions for storage
Does not require any special storage conditions
17th August 2015

Lactation Safety Information

Specialist drug/complex disease area for which expert advice is recommended

New Medicines

Celsentri (outside US), Selzentry (US) · HIV infection with only CCR5-tropic HIV-1 detectable in treatment-experienced adolescents and children of 2 years of age and older and weighing at least 10 kg - in combination with other antiretroviral medicinal products

Information

Celsentri (outside US), Selzentry (US)
Licence extension / variation and new formulation
ViiV Healthcare
ViiV Healthcare

Development and Regulatory status

Launched
Launched
None
December 2017

Dec 17: Launched in UK. Price 20mg/ml sugar-free oral soln, 230ml=£230.44 [5].


Jul 17: The SPC is available on the EMC;[3] however, the oral solution is not expected to be available until November this year due to manufacturing delays [4].


Apr 17: EU positive opinion for a licence change for use in adolescents and children of 2 years of age and older and weighing at least 10 kg [1].

Category

A chemokine receptor 5 (CCR5) antagonist
In 2005, the estimated vertical transmission rate in infants born in the UK to women infected with HIV was less than 4%. 120 children aged under 16 years were diagnosed as HIV-positive [2].
HIV infection with only CCR5-tropic HIV-1 detectable in treatment-experienced adolescents and children of 2 years of age and older and weighing at least 10 kg - in combination with other antiretroviral medicinal products
Oral

Evidence based evaluations

SMC