Regulatory Status of Dapoxetine in Spain

Janssen-Cilag have submitted a Marketing Authorisation Application (MAA) in Europe for dapoxetine, a treatment for premature ejaculation (PE) in men 18-64 years of age. The safety and efficacy of dapoxetine for the treatment of men with PE were studied in five, double-blind, placebo-controlled, Phase III clinical trials involving more than 6000 subjects from 30 countries worldwide, including countries in North America, South America, Europe and Asia, and in Israel and South Africa. The results of all randomised studies were consistent and improvements included both increases in average intravaginal ejaculatory latency time (IELT) and improved patient-reported outcomes of increased control over ejaculation and reduced personal distress related to ejaculation. The most common adverse drug reactions reported during clinical trials were headache, dizziness, nausea, diarrhoea, insomnia and fatigue.

Over Dose

[6] As a member of the SSRI family, dapoxetine was initially created as an antidepressant. However, unlike other SSRIs, dapoxetine is absorbed and eliminated rapidly in the body. This study will be carried out on 60 patients with lifelong premature ejaculation and non-responding to dapoxetine alone. All patients will be equally divided into 2 groups (30 patients each). Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse. Group 1 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse. Name: Mohammed A Abu El-Hamd, MD Sohag, Egypt, 82524RecruitingMohammed Abu El-Hamd Contact:Mohammed A Abu El-Hamd, MDPhone Number: 01004139060Email: Mohammedadva@yahoo.com Sohag, Egypt, 82524RecruitingMohammed Abu El-Hamd Contact:Mohammed A Abu El-Hamd, MDPhone Number: 01004139060Email: Mohammedadva@yahoo.com Sohag, Egypt, 82524RecruitingMohammed Abu El-Hamd Contact:Mohammed A Abu El-Hamd, MDPhone Number: 01004139060Email: Mohammedadva@yahoo.com Contact:Mohammed A Abu El-Hamd, MDPhone Number: 01004139060Email: Mohammedadva@yahoo.com lifelong premature ejaculation and non-responding to dapoxetine alone. Principal Investigator: Mohammed A El-Hamd, Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well. Janssen Research & Development, LLCCompletedSexual Dysfunction, Physiological EjaculationGermany, Spain, Portugal, Finland, Sweden, Austria Johnson & Johnson Pharmaceutical Research & Development...CompletedSexual Dysfunction Ejaculation Sohag UniversityCompletedVitamin D, Vitamin B12 and Folic Acid Among Patients With Premature EjaculationEgypt Abant Izzet Baysal UniversityCompletedEjaculatory Dysfunction Sexual Dysfunction Male Premature (Early) EjaculationTurkey (Türkiye) PfizerCompletedEjaculationItaly, Spain, Australia, Austria, Canada, Czech Republic, France, Germany, Israel, Norway, Poland, Sweden, Turkey, Netherlands Institute for the Study of Urological Diseases,...RecruitingErectile DysfunctionGreece Centro Universitario de Ciencias de la Salud, MexicoUnknownObesity and Erectile DysfuntionMexico Saint Petersburg State University, RussiaRecruitingErectile DysfunctionRussian Federation Futura Medical Developments Ltd.CompletedErectile DysfunctionUnited States, Bulgaria, Georgia, Poland Product Avanafil CAS#330784-47-9; Vildagliptin CAS#274901-16-5Documentation: DMF, WC,COA Specification: in-house Product Oseltamivir Phosphate CAS#204255-11-8For the treatment and prevention of influenza A and B in adults and children one year and older. Specification: USP, EP, BP, CHP Documentation: DMF, WC, COA, GMP Product Tadalafil CAS#171596-29-5For the treatment of erectile dysfunction. Specification: USP, EP, BP Documentation: DMF, WC, COA, GMP Product DAPOXETINE HYDROCHLORIDEThis product is indicated for premature ejaculation(PE) in men aged 18 to 64 years. Product OSELTAMIVIR PHOSPHATEFor the treatment and prevention of influenza A and B in adults and children one year and older. Product Sildenafil dapoxetine 60 mg tablets CitrateFor the treatment of penile erectile dysfunction in men. Product TADALAFILFor the treatment of erectile dysfunction for men.

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Product Vardenafil HydrochlorideFor the treatment of penile erectile dysfunction in men. Brochure PRODUCT LIST OF PHARMA JITAIThe APIs and intermediates which producing by ourself included in this this product list.

Before taking Tadalafil and Dapoxetine,

Dapoxetine is an oral medication used for treatment of premature ejaculation (PE) in men aged (18–64 years).

Satisfaction Level	Percentage of Patients	Common Feedback	Improvement Suggestions
Very Satisfied	55%	Effective, quick action	Reduce side effects
Satisfied	25%	Works most of the time	More consistent dosing
Neutral	10%	Variable results	Better counseling on use
Dissatisfied	10%	Side effects or inefficacy	Adjust dosage or alternative

In this study, we present a validated, precise and sensitive method for determination of dapoxetine in human plasma by liquid chromatography/ electrospray ionization-tandem mass spectrometry. Dapoxetine and the internal standard (Dapoxetine- d6) were extracted from plasma via liquid–liquid extraction (LLE). The LC separation was performed utilizing ACE C8 (4.6 X50) mm, 5 µm column. The mobile phase was composed of acetonitrile and buffer (0.01 M Ammonium acetate +0.02% Formic acid solution) (85:15, v/v). The method was linear within the concentration range of 5.0–600 ng/mL for Dapoxetine in human plasma. Short analytical run was achieved with 1.6 min run time.

Mode of Action

Dapoxetine Hydrochloride exporters data on Eximpedia includes shipment-level records, exporter details, importing countries, HS codes, quantities, and export values. Users can analyse Dapoxetine Hydrochloride export trade data to understand sourcing patterns, demand trends, and buyer behaviour across global markets. Eximpedia’s Dapoxetine Hydrochloride export statistics are derived from verified customs and shipping records. Our data is regularly updated to ensure accuracy, helping users rely on real trade movements rather than estimates or outdated reports. Yes, we provide a verified list of Dapoxetine Hydrochloride exporters based on actual Dapoxetine Hydrochloride export shipment records.

How is the study designed?

This allows importers and suppliers to connect with genuine buyers actively exporting Dapoxetine Hydrochloride in specific countries. The Dapoxetine Hydrochloride HSN code helps classify Dapoxetine Hydrochloride products correctly during customs clearance. Using the correct HS code Dapoxetine Hydrochloride export classification ensures compliance with regulations, accurate duty calculation, and smooth international trade operations. Dapoxetine Hydrochloride export shipment data helps businesses track real-time trade flows, identify active buyers, analyse competitor exports, and monitor supply chain routes. Our data-driven dashboard supports smarter sourcing and sales strategies.

Product Sildenafil Citrate

Yes, we offer Dapoxetine Hydrochloride buyers data by country, allowing users to compare export volumes, supplier countries, and demand trends across multiple markets. This is ideal for exporters planning market expansion. exporters, importers, traders, logistics companies, researchers, and policymakers can all benefit from Eximpedia’s Dapoxetine Hydrochloride exporters database by gaining accurate insights into the global Dapoxetine Hydrochloride export market. See all that you can accomplish with Eximpedia Dapoxetine, sold under the brand name Priligy among others, is a selective serotonin reuptake inhibitor (SSRI) used for the treatment of premature ejaculation (PE) in men ages 18 to 64 years old. [3][4][5] Dapoxetine works by inhibiting the serotonin transporter, increasing serotonin's action at the postsynaptic cleft, and as a consequence promoting ejaculatory delay. Intra-day and inter-day accuracy was between 97 and 106% with precision (CV, %) of ≤ 5% achieved across all the quality control samples.

• Spain's regulatory agency approved dapoxetine after clinical review.
• Generic forms of dapoxetine are also available in Spain.
• Patients should avoid driving after taking dapoxetine if dizzy.
• The drug's effect lasts for about 12 hours.
• Dapoxetine has minimal impact on long-term sexual function.
• It is contraindicated with certain antidepressants.
• Healthcare providers in Spain monitor side effects closely.

Dapoxetine was stable in several conditions with recovery rates > 90%. This method was utilized successfully in clinical pharmacokinetic study following oral administration of 60 mg Dapoxetine tablets in 36 healthy male subjects. The result for all 90% confidence intervals were within the preset ranges. The method proved to be highly reproducible and sensitive and thus can be employed in bioequivalence studies and large scale sample analysis of Dapoxetine.

Adverse effects

Janssen-Cilag have submitted a Marketing Authorisation Application (MAA) in Europe for dapoxetine, a treatment for premature ejaculation (PE) in men 18-64 years of age. The safety and efficacy of dapoxetine for the treatment of men with PE were studied in five, double-blind, placebo-controlled, Phase III clinical trials involving more than 6000 subjects from 30 countries worldwide, including countries in North America, South America, Europe and Asia, and in Israel and South Africa. The results of all randomised studies were consistent and improvements included both increases in average intravaginal ejaculatory latency time (IELT) and improved patient-reported outcomes of increased control over ejaculation and reduced personal distress related to ejaculation. The most common adverse drug reactions reported during clinical trials were headache, dizziness, nausea, diarrhoea, insomnia and fatigue. This study will be carried out on 60 patients with lifelong premature ejaculation and non-responding to dapoxetine alone.

Study Locations

All patients will be equally divided into 2 groups (30 patients each). Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse. Group 1 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse. Name: Mohammed A Abu El-Hamd, MD Sohag, Egypt, 82524RecruitingMohammed Abu El-Hamd Contact:Mohammed A Abu El-Hamd, MDPhone Number: 01004139060Email: Mohammedadva@yahoo.com Sohag, Egypt, 82524RecruitingMohammed Abu El-Hamd Contact:Mohammed A Abu El-Hamd, MDPhone Number: 01004139060Email: Mohammedadva@yahoo.com Sohag, Egypt, 82524RecruitingMohammed Abu El-Hamd Contact:Mohammed A Abu El-Hamd, MDPhone Number: 01004139060Email: Mohammedadva@yahoo.com Contact:Mohammed A Abu El-Hamd, MDPhone Number: 01004139060Email: Mohammedadva@yahoo.com lifelong premature ejaculation and non-responding to dapoxetine alone. Principal Investigator: Mohammed A El-Hamd, Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University This information was retrieved directly from the website clinicaltrials.gov without any changes.

Product OSELTAMIVIR PHOSPHATE

If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well. Janssen Research & Development, LLCCompletedSexual Dysfunction, Physiological EjaculationGermany, Spain, Portugal, Finland, Sweden, Austria Johnson & Johnson Pharmaceutical Research & Development...CompletedSexual Dysfunction Ejaculation Sohag UniversityCompletedVitamin D, Vitamin B12 and Folic Acid Among Patients With Premature EjaculationEgypt Abant Izzet Baysal UniversityCompletedEjaculatory Dysfunction Sexual Dysfunction Male Premature (Early) EjaculationTurkey (Türkiye) PfizerCompletedEjaculationItaly, Spain, Australia, Austria, Canada, Czech Republic, France, Germany, Israel, Norway, Poland, Sweden, Turkey, Netherlands Institute for the Study of Urological Diseases,...RecruitingErectile DysfunctionGreece Centro Universitario de Ciencias de la Salud, MexicoUnknownObesity and Erectile DysfuntionMexico Saint Petersburg State University, RussiaRecruitingErectile DysfunctionRussian Federation Futura Medical Developments Ltd.CompletedErectile DysfunctionUnited States, Bulgaria, Georgia, Poland Product Avanafil CAS#330784-47-9; Vildagliptin CAS#274901-16-5Documentation: DMF, WC,COA Specification: in-house Product Oseltamivir Phosphate CAS#204255-11-8For the treatment and prevention of influenza A and B in adults and children one year and older. Specification: USP, EP, BP, CHP Documentation: DMF, WC, COA, GMP Product Tadalafil CAS#171596-29-5For the treatment of erectile dysfunction. Specification: USP, EP, BP Documentation: DMF, WC, COA, GMP Product DAPOXETINE HYDROCHLORIDEThis product is indicated for premature ejaculation(PE) in men aged 18 to 64 years. Unlock Import & Export insights by typing your unique search query According to Dapoxetine Hydrochloride export data, buyers can access detailed shipment records based on customs details across multiple countries. It provides information such as product description, HS code, quantity, value, origin country, port details, and buyer-supplier names. The top Dapoxetine Hydrochloride exporting countries are UKRAINE, VIETNAM. Our global Dapoxetine Hydrochloride export data is sourced from over 200+ country and 150+ Indian ports (sea, air, ICDs & SEZs) Trade professionals frequently use India Dapoxetine Hydrochloride export data to evaluate sourcing trends and shipment volumes. This data offers visibility into India Dapoxetine Hydrochloride export data statistics, helping exporters assess which ports handle specific product categories more efficiently. Regulated under the India Dapoxetine Hydrochloride customs export data, these insights ensure compliance, safety, and transparency in cargo handling. With access to the Dapoxetine Hydrochloride shipment export data, businesses gain clarity on shipment frequency, origin countries, and cargo movement.

Before taking dapoxetine

Product OSELTAMIVIR PHOSPHATEFor the treatment and prevention of influenza A and B in adults and children one year and older. Product Sildenafil dapoxetine 60 mg tablets CitrateFor the treatment of penile erectile dysfunction in men. Product TADALAFILFor the treatment of erectile dysfunction for men. Product Vardenafil HydrochlorideFor the treatment of penile erectile dysfunction in men. Brochure PRODUCT LIST OF PHARMA JITAIThe APIs and intermediates which producing by ourself included in this this product list.

Study Registration Dates

Dapoxetine is an oral medication used for treatment of premature ejaculation (PE) in men aged (18–64 years). In this study, we present a validated, precise and sensitive method for determination of dapoxetine in human plasma by liquid chromatography/ electrospray ionization-tandem mass spectrometry. Dapoxetine and the internal standard (Dapoxetine- d6) were extracted from plasma via liquid–liquid extraction (LLE). The LC separation was performed utilizing ACE C8 (4.6 X50) mm, 5 µm column. The mobile phase was composed of acetonitrile and buffer (0.01 M Ammonium acetate +0.02% Formic acid solution) (85:15, v/v).

Product Tadalafil CAS#171596-29-5

The method was linear within the concentration range of 5.0–600 ng/mL for Dapoxetine in human plasma. Short analytical run was achieved with 1.6 min run time. Intra-day and inter-day accuracy was between 97 and 106% with precision (CV, %) of ≤ 5% achieved across all the quality control samples. Dapoxetine was stable in several conditions with recovery rates > 90%. This method was utilized successfully in clinical pharmacokinetic study following oral administration of 60 mg Dapoxetine tablets in 36 healthy male subjects. Insights derived from India Dapoxetine dapoxetine 5mg Hydrochloride exporters' statistics further help in understanding trade performance and identifying the top export ports.

Trend	Description	Expected Impact	Challenges
Increased Online Access	Growth in online pharmacy sales	Wider availability and convenience	Ensuring product authenticity
Expanded Demographic Use	Use among older populations for sexual health	Broader market potential	Medical supervision required
Regulatory Changes	Possible updates to prescription rules	Might increase accessibility	Balance between safety and access

Additionally, specialised India Dapoxetine Hydrochloride export statistics support containerized and multi-modal exports, strengthening the overall export infrastructure. Grab the Special Offer from Eximpedia and Start Exploring Global Import-Export Trade Data. Learn How our platform works in just 20 minutes! Free Import-Export Sample data-One Click Away! Check out the most commonly asked questions below. Dapoxetine Hydrochloride exporters data on Eximpedia includes shipment-level records, exporter details, importing countries, HS codes, quantities, and export values. Users can analyse Dapoxetine Hydrochloride export trade data to understand sourcing patterns, demand trends, and buyer behaviour across global markets. Eximpedia’s Dapoxetine Hydrochloride export statistics are derived from verified customs and shipping records.

Condition	Description	Approved Use in Spain	Alternative Treatments
Premature Ejaculation	Early ejaculation causing distress	Yes	Behavioral therapy, SSRIs
Anxiety Related to Sexual Activity	Performance anxiety	Off-label use	Counseling, relaxation techniques
Erectile Dysfunction	Sometimes co-treated	No	PDE5 inhibitors, therapy

Our data is regularly updated to ensure accuracy, helping users rely on real trade movements rather than estimates or outdated reports. Yes, we provide a verified list of Dapoxetine Hydrochloride exporters based on actual Dapoxetine Hydrochloride export shipment records. This allows importers and suppliers to connect with genuine buyers actively exporting Dapoxetine Hydrochloride in specific countries. The Dapoxetine Hydrochloride HSN code helps classify Dapoxetine Hydrochloride products correctly during customs clearance. Using the correct HS code Dapoxetine Hydrochloride export classification ensures compliance with regulations, accurate duty calculation, and smooth international trade operations. Dapoxetine Hydrochloride export shipment data helps businesses track real-time trade flows, identify active buyers, analyse competitor exports, and monitor supply chain routes. Our data-driven dashboard supports smarter sourcing and sales strategies. Yes, we offer Dapoxetine Hydrochloride buyers data by country, allowing users to compare export volumes, supplier countries, and demand trends across multiple markets.

More Information

The result for all 90% confidence intervals were within the preset ranges. The method proved to be highly reproducible and sensitive and thus can be employed in bioequivalence studies and large scale sample analysis of Dapoxetine. Unlock Import & Export insights by typing your unique search query According to Dapoxetine Hydrochloride export data, buyers can access detailed shipment records based on customs details across multiple countries. It provides information such as product description, HS code, quantity, value, origin country, port details, and buyer-supplier names. The top Dapoxetine Hydrochloride exporting countries are UKRAINE, VIETNAM.

Brand Names

Our global Dapoxetine Hydrochloride export data is sourced from over 200+ country and 150+ Indian ports (sea, air, ICDs & SEZs) Trade professionals frequently use India Dapoxetine Hydrochloride export data to evaluate sourcing trends and shipment volumes. This data offers visibility into India Dapoxetine Hydrochloride export data statistics, helping exporters assess which ports handle specific product categories more efficiently. Regulated under the India Dapoxetine Hydrochloride customs export data, these insights ensure compliance, safety, and transparency in cargo handling. With access to the Dapoxetine Hydrochloride shipment export data, businesses gain clarity on shipment frequency, origin countries, and cargo movement. Insights derived from India Dapoxetine dapoxetine 5mg Hydrochloride exporters' statistics further help in understanding trade performance and identifying the top export ports.

Plan for Individual participant data (IPD)

Additionally, specialised India Dapoxetine Hydrochloride export statistics support containerized and multi-modal exports, strengthening the overall export infrastructure. Grab the Special Offer from Eximpedia and Start Exploring Global Import-Export Trade Data. Learn How our platform works in just 20 minutes! Free Import-Export Sample data-One Click Away! Check out the most commonly asked questions below. This is ideal for exporters planning market expansion.

• Dapoxetine is recommended only for men with premature ejaculation.
• Regular follow-ups with a healthcare provider are advised.
• Some Spanish men prefer dapoxetine over other treatments.
• Dapoxetine is not suitable for men with cardiac conditions.
• It is important to disclose other medications when prescribing dapoxetine.
• Dapoxetine is not indicated for use in women or children.
• The medication helps improve confidence and reduces performance anxiety.

exporters, importers, traders, logistics companies, researchers, and policymakers can all benefit from Eximpedia’s Dapoxetine Hydrochloride exporters database by gaining accurate insights into the global Dapoxetine Hydrochloride export market. See all that you can accomplish with Eximpedia Dapoxetine, sold under the brand name Priligy among others, is a selective serotonin reuptake inhibitor (SSRI) used for the treatment of premature ejaculation (PE) in men ages 18 to 64 years old. [3][4][5] Dapoxetine works by inhibiting the serotonin transporter, increasing serotonin's action at the postsynaptic cleft, and as a consequence promoting ejaculatory delay. [6] As a member of the SSRI family, dapoxetine was initially created as an antidepressant. However, unlike other SSRIs, dapoxetine is absorbed and eliminated rapidly in the body.