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• ESTROGEN PILLS SIDE EFFECT PROFESSIONAL

This helps to restore the integrity of the vaginal wall, relieving vaginal symptoms of dryness, soreness, itching, burning and painful intercourse. Gina is a local oestrogen therapy that is gradually released directly into the vaginal tissue. Vaginal atrophy is currently diagnosed based on symptoms alone and without the need, in most women, for any physical examination, making it suitable for a pharmacy setting. The most common symptoms of vaginal atrophy are dryness, soreness, itching, burning and painful intercourse (sexual symptoms of lack of lubrication). Vaginal atrophy (VA) is a condition in which the decrease in oestrogen levels causes thinning of the tissues in and around the vagina, decreased flexibility and elasticity of the vagina and a decrease in the mucus production that provides a moist vaginal environment. Low dose vaginal oestrogens have been used for a number of years to treat vaginal atrophy that can arise due to diminished oestrogen production following the menopause. Gina is used for the treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women aged 50 years and above, who have not had a period for at least 1 year. The final decision on whether to approve a change is made by the MHRA, on behalf of the UK Licensing Authority. views of relevant public associations and individuals with an interest in the medicine under consideration.

ESTROGEN PILLS SIDE EFFECT PROFESSIONAL

views of relevant health professionals and their professional bodies.evidence showing acceptable level of side effects.This includes evidence on the possible abuse or misuse of the medicine. This evidence needs to focus on the risk to the public. To do this, they need to get together evidence to show that the medicineĪ) is likely to be used appropriately, andī) with relatively little danger to the public. What evidence is needed?Ī company or organisation can ask MHRA for a medicine to be available as a pharmacy medicine or a general sale medicine. ‘Reasonable safety’ is defined as ‘Where the hazard to health, risk of misuse and need for special precautions in handling of the medicine are small, and where the wider sale would be a convenience to the purchaser’. To be reclassified from P to GSL, it must be demonstrated that the medicine may be supplied with reasonable safety in outlets other than in pharmacies. not normally be prescribed by a doctor for injection (parenteral administration).not contain substances or preparations of substances where the activity of the product or its side effects require further investigation.

not frequently or to a wide extent used incorrectly)

To be reclassified from POM to P a medicine must: To be reclassified directly from POM to GSL, a medicine must meet both the requirements of POM to P and P to GSL reclassifications. In some cases, a medicine may be reclassified directly from POM to GSL, where it meets the necessary requirements and it is safe to do so. When a medicine is reclassified, it is usual for reclassification from POM to P to occur in the first instance, and once some experience is gained with the product in the pharmacy (P) setting, further reclassification from P to GSL may occur. take advice from a group (‘stakeholder group’) of health professionals and representatives of people affected by the classification change.take advice from its committees of external experts.This is sometimes referred to as ‘switching’. Making a change on where a medicine is available is called reclassification. to buy from other shops - ‘general sales list medicine’ (GSL).to buy from pharmacies - ‘pharmacy medicine’ (P).on prescription only - ‘prescription only medicine’ (POM).This means that MHRA decides whether medicines are available: MHRA regulates medicines and medical devices in the UK, on behalf of the UK Licensing Authority. Background on deciding where medicines are available The role of MHRA Gina 10 microgram vaginal tablets Active substanceĬurrent: prescription (POM) Proposed: from pharmacies Indicationįor the treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women aged 50 years and above, who have not had a period for at least 1 year Marketing Authorisation Number:Ġ2 February 2022 – 23 February 2022 ReferenceĪRM 101 1.