Goserelin-vista

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GOSERELIN-VISTA (GOSERELIN-VISTA)

Composition:

Active substance: goserelin;

One implant contains 4.10 mg of goserelin acetate, equivalent to 3.6 mg of goserelin;
Excipients: poly(D,L-lactide-co-glycolide) 50:50.

Pharmaceutical form. Implant in pre-filled syringes.

Main physicochemical properties: the implant is visible in the implant holder. Dimensions: length approximately 13 mm, diameter approximately 1.2 mm. Functionality: after activation of the applicator, an intact cylindrical rod of white to almost white color emerges from the needle.

Pharmacotherapeutic group.
Gonadotropin-releasing hormone analogues. ATC code: L02AE03.

Pharmacological properties.

Pharmacodynamics.

Mechanism of action.

Goserelin (D-Ser(But)6 Azgly10 LH-RH) is a synthetic analogue of the natural luteinizing hormone-releasing hormone (LH-RH). With continuous administration, goserelin inhibits pituitary secretion of LH, leading to a reduction in serum testosterone concentrations in men and serum estradiol concentrations in women. This effect is reversible upon discontinuation of therapy. During the initial phase, goserelin, like other LH-RH agonists, may cause a transient increase in serum testosterone concentrations in men and serum estradi0l concentrations in women.

In men, testosterone concentrations decrease to castration levels by approximately day 21 after administration of the first implant and remain suppressed with continuous administration of the drug every 28 days. This reduction in testosterone concentration leads to tumor regression and symptomatic improvement in most patients with prostate cancer.

In clinical studies involving patients with metastatic prostate cancer, goserelin has been shown to produce outcomes similar to those of surgical castration.

In trials comparing monotherapy with bicalutamide 150 mg versus castration (predominantly via goserelin), no significant difference in overall survival was observed between patients with locally advanced prostate cancer receiving bicalutamide and those undergoing castration (hazard ratio = 1.05 [95% CI: 0.81–1.36]). However, statistical equivalence between the two treatment approaches cannot be established.

Goserelin has been reported to improve disease-free survival and overall survival when used as adjuvant therapy combined with radiotherapy in patients with localized intermediate-risk (T1–T2 and PSA [prostate-specific antigen] ≥10 ng/mL or Gleason score of 7) or locally advanced (T3–T4) prostate cancer. The optimal duration of adjuvant therapy has not been established; studies have shown that 3 years of adjuvant goserelin therapy significantly improves survival compared to radiotherapy alone. Neoadjuvant goserelin therapy combined with radiotherapy has been shown to improve disease-free survival in patients with localized or locally advanced prostate cancer.

Following prostatectomy in patients with locally advanced prostate cancer, adjuvant therapy with the drug may improve recurrence-free survival, although significant improvement in overall survival has not been demonstrated in patients without lymph node involvement at the time of surgery. Patients with locally advanced disease confirmed histopathologically and additional risk factors such as PSA ≥10 ng/mL or Gleason score of 7 prior to adjuvant therapy should undergo thorough evaluation. There is no evidence of improved clinical outcomes with neoadjuvant goserelin therapy following radical prostatectomy.

In women, serum estradiol concentrations decrease to postmenopausal levels by approximately day 21 after administration of the first implant and remain suppressed with continuous treatment every 28 days. This suppression provides beneficial effects in hormone-dependent breast cancer, uterine fibroids, endometriosis, and inhibition of ovarian follicular development. It also results in endometrial thinning and amenorrhea in most patients.

During treatment with LH-RH analogues, some women may enter menopause. Rarely, menstruation does not resume after discontinuation of therapy.

Goserelin in combination with iron supplements has been shown to induce amenorrhea, thereby increasing hemoglobin levels and improving hematological parameters compared to iron therapy alone. This combination resulted in a mean hemoglobin concentration 1 g/dL higher than that achieved with iron therapy alone.

Pharmacokinetics.

Goserelin has nearly complete bioavailability. Administration of the implant every 4 weeks maintains effective drug concentrations. There is no tissue accumulation. Goserelin is poorly protein-bound, and its serum half-life is 2–4 hours in patients with normal renal function. The half-life is prolonged in patients with impaired renal function. However, this change is not clinically significant with monthly administration, and therefore dosage adjustment is not required in patients with renal impairment. No significant changes in pharmacokinetic parameters are observed in patients with hepatic insufficiency.

Clinical characteristics.

Indications.

Prostate cancer.

Treatment of prostate cancer in the following cases:

• treatment of metastatic prostate cancer – administration of goserelin favourably influenced survival, similar to the effect of surgical castration;
• treatment of locally advanced prostate cancer as an alternative to surgical castration – administration of goserelin favourably influenced survival, similar to the effect of antiandrogen therapy;
• as adjuvant therapy to radiotherapy in patients with localized prostate cancer at high risk or locally advanced prostate cancer – administration of goserelin improved disease-free survival and overall survival;
• as neoadjuvant therapy prior to radiotherapy in patients with localized high-risk prostate cancer or locally advanced prostate cancer – administration of goserelin improved disease-free survival;
• as adjuvant therapy following radical prostatectomy in patients with locally advanced prostate cancer and a high risk of disease progression – administration of goserelin improved disease-free survival.

Breast cancer.
Treatment of advanced, hormonally responsive breast cancer in pre- and perimenopausal women.

As an alternative to chemotherapy in the standard treatment of pre- and perimenopausal women with estrogen receptor-positive early breast cancer.

Endometriosis.
Relieves symptoms including pain, and reduces the size and number of endometrial lesions.

Endometrial thinning.
For prior thinning of the endometrium before endometrial ablation or resection.

Uterine fibroids.
In combination with iron therapy – to improve hematological status in anemic patients with fibroids prior to surgical intervention.

In vitro fertilization.
Pituitary desensitization in preparation for superovulation stimulation.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients.

Pregnancy or breastfeeding.

Paediatric age.

Interaction with other medicinal products and other forms of interaction.

Since androgen deprivation therapy may lead to QT interval prolongation, concomitant use of goserelin with medicinal products capable of prolonging the QT interval or causing torsades de pointes ventricular tachycardia, such as class IA antiarrhythmics (e.g., quinidine, disopyramide) or class III antiarrhythmics (e.g., amiodarone, sotalol, dofetilide, ibutilide), methadone, moxifloxacin, and antipsychotic medicinal products, should be carefully considered (see section "Special precautions for use").

Special precautions for use.

There is a high risk of developing depression (which may be severe) in patients receiving treatment with gonadotropin-releasing hormone agonists such as goserelin. Patients should be informed about this risk and provided with appropriate treatment should symptoms occur.

Androgen deprivation therapy may lead to QT interval prolongation.

Before prescribing goserelin to patients with a history of QT interval prolongation or risk factors for QT prolongation, as well as to patients concurrently using medicinal products that may cause QT prolongation (see section "Interaction with other medicinal products and other forms of interaction"), physicians must assess the benefit-risk ratio, including the potential risk of developing torsades de pointes ventricular tachycardia.

Injection site reactions, including pain, haematoma, bleeding, and vascular injury, have been reported with goserelin use. Patients should be monitored for signs or symptoms of abdominal bleeding. In very rare cases, administration errors have led to vascular injury and haemorrhagic shock requiring blood transfusion and surgical intervention. Particular caution is required when administering the medicinal product to patients with low body mass index (BMI) and/or those receiving full anticoagulant therapy (see section "Method of administration and dosage").

Men.

Goserelin should be used with caution in men at risk of developing urinary tract obstruction or spinal cord compression, and such patients should be closely monitored during the first month of therapy. Standard treatment for these complications should be initiated if spinal cord compression or renal insufficiency due to urinary tract obstruction occurs.

Consideration should be given to prescribing antiandrogens during the initial treatment period with GnRH analogues (e.g., cyproterone acetate 300 mg/day for 3 days before and 3 weeks after initiating goserelin), as this has been reported to prevent potential consequences of the initial rise in serum testosterone levels.

It is unlikely that patients with non-hormone-dependent prostate cancer will benefit from this treatment. This resistance to therapy may result from the absence of response to castration or hormonal therapy.

Testosterone measurement before initiating treatment is recommended to allow assessment of therapeutic benefit.

Administration of GnRH agonists may lead to decreased bone mineral density. Preliminary data suggest that the addition of bisphosphonates to GnRH agonist therapy may reduce bone mineral loss in men. Particular caution is required in patients with additional risk factors for osteoporosis (chronic alcohol abuse, smoking, long-term therapy with anticonvulsants or corticosteroids, family history of osteoporosis).

Mood changes, including depression, have been reported. Close monitoring is required for patients with established depression and those with hypertension.

There is a high risk of hypotension (which may be severe) in patients treated with GnRH agonists such as goserelin. Patients should be informed of this risk and managed appropriately if symptoms occur.

In a pharmacoepidemiological study of GnRH agonists used for the treatment of prostate cancer, cases of myocardial infarction and heart failure were observed.

The risk increases when the medicinal product is used in combination with antiandrogenic agents. Reduced glucose tolerance has been observed in men treated with GnRH agonists. This may manifest as diabetes mellitus or loss of glycaemic control in patients with pre-existing diabetes. Therefore, monitoring of blood glucose levels is required.

Women.

Breast cancer as an indication.

Reduction in bone mineral density.

Administration of GnRH agonists may lead to decreased bone mineral density. After 2 years of treatment for early-stage breast cancer, the mean reduction in bone mineral density at the femoral neck and lumbar spine in women was 6.2% and 11.5%, respectively. These losses have been shown to be partially reversible: one year after treatment discontinuation, bone mineral density loss at the femoral neck and lumbar spine was 3.4% and 6.4% less, respectively, than before treatment initiation, although data on bone mass recovery are very limited. According to available data, in most women bone mass recovers after treatment cessation.

Preliminary data indicate that the use of goserelin in combination with tamoxifen in breast cancer patients may reduce bone mineral loss.

Benign conditions as an indication.

Loss of bone mineral density.

GnRH agonists may cause a reduction in bone mineral density of approximately 1% every 6 months of treatment. A 10% decrease in bone mineral density approximately doubles to triples the risk of fractures. According to available data, bone mass recovers in most women after treatment discontinuation.

In patients receiving goserelin for endometriosis treatment, additional hormone replacement therapy has been shown to attenuate the reduction in bone mineral density and the severity of vasomotor symptoms.

There are no specific data on the use of the medicinal product in patients with established osteoporosis or risk factors for its development (such as chronic alcohol abuse, smoking, long-term therapy with drugs that reduce bone mineral density, e.g., anticonvulsants or corticosteroids, family history of osteoporosis, eating disorders such as anorexia nervosa). Since reduced bone mineral density may be more hazardous in such patients, the appropriateness of goserelin use should be evaluated on a case-by-case basis, and therapy should only be initiated if benefits outweigh risks. Additional measures to counteract bone mineral loss should be considered.

Withdrawal bleeding.

At the beginning of goserelin treatment, some patients may experience vaginal bleeding of varying duration and intensity. This usually occurs within the first month after treatment initiation, likely as a reaction to estrogen withdrawal, and resolves spontaneously. If bleeding persists, its cause should be investigated.

There are no clinical data on the effect of goserelin use for the treatment of benign gynaecological conditions beyond 6 months.

Goserelin use may increase cervical resistance; therefore, caution should be exercised during cervical dilation.

Goserelin should only be used in assisted reproduction under the supervision of a specialist experienced in this field.

As with other GnRH agonists, cases of ovarian hyperstimulation syndrome (OHSS) have been reported with the use of 3.6 mg goserelin in combination with gonadotropin. The stimulation cycle should be carefully monitored to identify patients at risk of developing OHSS. If OHSS risk is present, administration of human chorionic gonadotropin (hCG) should be withheld.

Goserelin should be used with caution in fertilization procedures for patients with polycystic ovary syndrome, as a large number of follicles may be stimulated.

Women of reproductive age must use non-hormonal contraception during goserelin therapy and until menstruation resumes after treatment completion.

Close monitoring is required for patients with established depression and those with hypertension.

Goserelin use may result in a positive anti-doping test.

Use during pregnancy or breastfeeding.

Goserelin should not be used during pregnancy, as there is a theoretical risk of miscarriage or fetal abnormalities if GnRH agonists are administered during pregnancy. Women who may become pregnant should be carefully evaluated to exclude pregnancy.

Non-hormonal contraception should be used during treatment until menstruation resumes (see also precautions regarding the time required for menstruation recovery in the section "Special precautions for use").

Pregnancy must be excluded before initiating goserelin. There are no clinical data indicating a causal relationship between goserelin use and any subsequent oocyte, pregnancy, or pregnancy outcome abnormalities.

The use of goserelin during breastfeeding is not recommended. Menopause may naturally occur during treatment with GnRH analogues. Rarely, in some women, menstruation does not resume after treatment discontinuation.

Ability to affect reaction speed when driving or operating machinery.

The medicinal product has no effect or has a negligible effect on the ability to drive or operate machinery.

Administration and Dosage.

Goserelin-Vista should be administered with caution into the anterior abdominal wall due to the proximity of the inferior epigastric artery and its branches.

Particular caution is required when administering the medicinal product to patients with low BMI or those receiving anticoagulant therapy (see section "Special Precautions").

The injection must be administered subcutaneously according to the technique described in the administration instructions. The medicinal product must not be injected into blood vessels, muscle, or the peritoneal cavity.

If surgical removal of the goserelin implant becomes necessary, its location can be determined using ultrasound imaging.

Adults.

One 3.6 mg implant of Goserelin-Vista should be administered subcutaneously into the anterior abdominal wall every 28 days.

Dosage adjustment is not required for patients with renal or hepatic impairment, or for elderly patients.

In vitro fertilization (IVF).

Goserelin-Vista 3.6 mg is indicated for pituitary desensitization, determined by serum estradiol levels and corresponding to early follicular phase levels (approximately 150 pmol/L). This typically occurs between day 7 and day 21 of the menstrual cycle.

Controlled ovarian hyperstimulation with gonadotropins should be initiated once desensitization has been achieved. Desensitization induced by agonist implant administration is more profound, which may necessitate higher gonadotropin doses in some cases. When adequate follicular development is reached, gonadotropin administration should be discontinued and human chorionic gonadotropin (hCG) administered to induce ovulation. Treatment monitoring, oocyte retrieval, and fertilization should be performed according to standard practices of each treatment center.

Endometriosis should be treated for no longer than 6 months, as clinical data on longer treatment durations are currently lacking. Repeat treatment courses should be avoided due to the risk of decreased bone mineral density. It has been demonstrated that in patients receiving goserelin for endometriosis treatment, additional hormone replacement therapy (daily administration of estrogen and progestogen) reduces bone mineral density loss and alleviates vasomotor symptoms.

For endometrial thinning, the medicinal product should be administered for 4 or 8 weeks. In cases of large uterine size or uncertain timing of surgical intervention, a second capsule may be required.

Uterine fibroids.

Women with anemia caused by uterine fibroids may receive Goserelin-Vista 3.6 mg in combination with iron supplements for 3 months prior to surgical intervention.

Administration Instructions.

Use according to the recommendations of the prescribing physician. Particular caution is required when administering goserelin to patients with low BMI and/or those receiving full-dose anticoagulant therapy (see section "Special Precautions").

Administration Guidelines.

Use only if the applicator syringe pouch is undamaged. Use immediately after opening the pouch.

Local anesthesia may be used, but is generally not required. Dispose of the syringe in a dedicated sharps container. The following information is intended for healthcare professionals only.

Goserelin-Vista is administered via subcutaneous injection. Prior to administration, the instructions below must be reviewed.

Position the patient comfortably with the upper body slightly elevated. Prepare the injection site according to current guidelines.

NOTE. Exercise caution when administering the medicinal product into the anterior abdominal wall due to the proximity of the inferior epigastric artery and its branches; in very thin patients, the risk of vascular injury is increased.

Figure 1

Inspect the sterile packaging and applicator syringe for damage. Remove the syringe from its sterile packaging. Hold the applicator syringe at a slight angle to the light. Ensure that the Goserelin-Vista implant is at least partially visible. Remove the protective ring.

Figure 2

Grasp the applicator syringe by the body and remove the protective cap.

Unlike liquid injections, air bubbles should not be expelled—attempting to do so may displace the Goserelin-Vista implant.

Figure 3

Pinch the patient’s skin with two fingers while simultaneously gripping the syringe body, and insert the needle obliquely (almost parallel to the skin).

Insert the needle into the subcutaneous tissue (not into muscle or the peritoneal cavity) of the anterior abdominal wall, below the umbilical line, advancing until the body of the applicator syringe contacts the patient’s skin.

This skin contact must be maintained throughout the entire implant administration process!

NOTE. The Goserelin-Vista applicator syringe cannot be used for aspiration. If the injection needle penetrates a large vessel, blood will be immediately visible in the syringe chamber. In case of vessel puncture, withdraw the needle immediately, apply pressure to stop bleeding, and monitor the patient for signs or symptoms of abdominal hemorrhage. Once hemodynamic stability is confirmed, another Goserelin-Vista implant may be administered using a new syringe at an alternate injection site. Exercise particular caution when administering the medicinal product to patients with low BMI and/or those receiving full-dose anticoagulant therapy.

Figure 4

Depress the plunger. As pressure is applied, the subcutaneous implant moves from the holder to the needle tip.

Under no circumstances should the syringe be pulled backward. During implant administration, the body of the applicator syringe must remain in contact with the patient’s skin.

Figure 5

When the plunger reaches its final position, the automatic needle retraction mechanism activates, and the plunger secures the implant in the subcutaneous tissue.

Figure 6

The needle retracts from the patient’s tissue into the polymer body of the applicator syringe. The syringe body should remain in contact with the patient’s skin. Typically, forward movement of the plunger and needle retraction occur in one smooth motion.

Figure 7

The subcutaneous implant administration process is complete. The needle is fully retracted into the syringe body.

The protective covering of the applicator syringe body prevents injury from the needle tip.

Figure 8

Replace the protective cap.

Do not insert the needle into muscle or the peritoneal cavity.

Dispose of the syringe in a dedicated sharps container.

NOTE. If surgical removal of the implant becomes necessary (although this is unlikely), its location can be identified using ultrasound scanning.

Children.

The medicinal product is not indicated for use in children, as safety and efficacy in this patient population have not been established.

Overdose.

Symptoms. Human experience with overdose is limited. No clinically significant adverse effects have been observed following premature or higher-than-recommended administration of goserelin. Animal studies show no effects other than the therapeutic ones on sex hormone levels and reproductive organs at higher goserelin doses.

Treatment. In case of overdose, symptomatic treatment should be provided.

Adverse Reactions

The frequency of adverse reactions was determined based on data from clinical studies and post-marketing reports. The most commonly reported adverse reactions included hot flushes, sweating, and injection site reactions.

Adverse events are categorized by frequency as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000), and frequency not known (cannot be estimated from the available data). Adverse reactions to goserelin by organ system according to MedDRA.

Organ systems	Frequency	Men	Women
Benign, malignant and unspecified neoplasms (including cysts and polyps)	Very rare	Pituitary tumors	Pituitary tumors
	Frequency unknown	-	Uterine fibroid degeneration
Immune system disorders	Uncommon	Hypersensitivity reactions to the medicinal product.	Hypersensitivity reactions to the medicinal product.
	Rare	Anaphylactic reactions	Anaphylactic reactions
Endocrine system disorders	Very rare	Pituitary hemorrhage	Pituitary hemorrhage
Metabolism and nutritional disorders	Common	Impaired glucose tolerancea	-
Psychiatric disorders	Very common	Decreased libidob	Decreased libidob
	Common	Mood changes, depression	Mood changes, depression
	Very rare	Psychiatric disorders	Psychiatric disorders
Nervous system disorders	Common	Paraesthesia	Paraesthesia
		Spinal cord compression	-
		-	Headache
Cardiac and vascular disorders	Very common	Hot flushesb	Hot flushesb
	Common	Heart failuref, myocardial infarctionf, arterial pressure disordersc	Arterial pressure disordersc
	Frequency unknown	QT interval prolongation (see sections "Special warnings and precautions for use" and "Interaction with other medicinal products and other forms of interaction")	-
Skin and subcutaneous tissue disorders	Very common	Hyperhidrosisb	Hyperhidrosisb, acnei
	Common	Rashd	Rashd, hair lossh
	Frequency unknown	Alopeciag	(see common)
Musculoskeletal and connective tissue disorders	Common	Bone paine	-
	Uncommon	Arthralgia	Arthralgia
Renal and urinary disorders	Uncommon	Ureteral obstruction	-
Reproductive system and breast disorders	Very common	Erectile dysfunction	-
		-	Vulvovaginal dryness
		-	Breast enlargement
	Common	Gynecomastia	-
	Uncommon	Breast tenderness	-
	Rare	-	Ovarian cysts
	Frequency unknown	-	Withdrawal bleeding
General disorders and administration site conditions	Very common	-	Injection site reactions
	Common	Injection site reactions	Injection site reactions
		-	Tumor flare, painful tumor
Laboratory findings	Common	Decreased bone density (see section "Special warnings and precautions for use"), increased body weight	Decreased bone density, increased body weight

a Decreased glucose tolerance was observed in men receiving GnRH agonists. This may manifest as diabetes mellitus or loss of glycemic control in individuals who already have diabetes.

b These pharmacological effects rarely require discontinuation of therapy. Hyperhidrosis and hot flushes may persist after stopping goserelin.

c Hypo- or hypertension has occasionally been observed in patients receiving goserelin. Changes are usually temporary and resolve either during continued therapy or after discontinuation of goserelin. Rarely, such changes required medical intervention, including discontinuation of goserelin.

d Usually mild, and often decreases without the need to discontinue treatment.

e Initially, patients with prostate cancer may experience a temporary increase in bone pain; in such cases, symptomatic treatment may be prescribed.

f Observed in pharmacoepidemiological studies of GnRH agonists used in the treatment of prostate cancer. The risk apparently increases when used in combination with antiandrogen agents.

g Particularly, loss of body hair is an expected effect due to decreased androgen levels.

h Hair loss on the head has been observed in women, including young women, treated for benign gynecological conditions. This phenomenon is usually mild, but occasionally may be severe.

i In most cases, acne occurred within one month after initiation of treatment.

Goserelin may cause: hepatic dysfunction and development of jaundice with increased levels of alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase; increased levels of lactate dehydrogenase, alkaline phosphatase, triglycerides; epistaxis, urticaria, pruritus.

Also, during treatment with this medicinal product, the following may occur: urinary system – dysuria, increased blood urea nitrogen, elevated creatinine levels, proteinuria; blood system – anemia, leucopenia, thrombocytopenia.

During administration of goserelin, injection site reactions (bleeding, hematoma, abscess, induration, pain), bleeding around the injection site leading to hemorrhagic shock, may occur.

Post-marketing experience.

Rarely, abnormal blood test results, cases of hepatic dysfunction, pulmonary embolism, and interstitial pneumonia have been observed with goserelin use. In women treated for endometriosis and/or fibroids, hypercalcemia has rarely been reported. In case of symptoms suggestive of hypercalcemia (e.g., thirst), appropriate investigations should be performed to exclude it.

Additionally, in women receiving the drug for benign gynecological conditions, the following adverse reactions have been observed: acne, changes in body hair, dry skin, weight gain, increased serum cholesterol levels, ovarian hyperstimulation syndrome (when used in combination with gonadotropins), vaginitis, vaginal discharge, nervousness, sleep disturbances, fatigue, peripheral edema, myalgia, calf muscle cramps, nausea, vomiting, diarrhea, constipation, abdominal disorders, voice changes.

At the beginning of treatment, disease symptoms may temporarily worsen; in such cases, symptomatic treatment may be prescribed.

Rarely, during treatment with GnRH analogs in women, menopause may occur, and menstruation may not resume after completion of therapy. It is unclear whether this is an effect of goserelin or a consequence of the underlying gynecological conditions.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after drug registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy to the State Expert Center of the Ministry of Health of Ukraine via the following link: https://aisf.dec.gov.ua

Shelf life. 4 years.

Use only if the pouch containing the applicator syringe is undamaged.

Use immediately after opening the pouch.

Storage conditions.

Store in the original packaging at a temperature not exceeding 30 °C. Keep out of reach of children.

Packaging.

One implant in an applicator syringe (the applicator syringe consists of a polymer body with an implant holder, needle, and plunger). One syringe in a pouch together with a moisture-absorbing capsule. One or three pouches in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

AMW GmbH / AMW GmbH

Manufacturer's address and location of business activity.

Birkerfeld 11, Lochham, Warngau, Bavaria, 83627, Germany / Birkerfeld 11, Lochham, Warngau, Bavaria, 83627, Germany

Marketing Authorization Holder.

Mistral Capital Management Limited