natgillin/translations-raw huggingface dataset:
Slovenija Servier Pharma, d. o. o., Tel.: +386 (0)1 563 48 11
Tel.: +386 (0) 1 563 48 11
EU-Numbers
Num rul UE
Invented name
Concentra ia
Strength
Con inutul
Pharmaceutical Form
M rimea ambalajului
Route of administration
EU/ 1/ 01/ 173/ 001 Vaniqa
Packaging
Tub (HDPE)
Content (concentration) Package sizes
15 g (11. 5% w/ w)
EU/ 1/ 01/ 173/ 001 EU/ 1/ 01/ 173/ 002 EU/ 1/ 01/ 173/ 003
EU/ 1/ 01/ 173/ 002 Vaniqa
Vaniqa Vaniqa Vaniqa
EU/ 1/ 01/ 173/ 003 Vaniqa
11.5% 11.5% 11.5%
11. 5%
Cream Cream Cream
Crem
Cutaneous use Cutaneous use Cutaneous use
cutanat Administrare cutanat
Tube (HDPE) Tube (HDPE) Tube (HDPE)
(HDPE) Tub (HDPE)
15 g (11.5% w/ w) 30 g (11.5% w/ w) 60 g (11.5% w/ w)
w/ w) 60 g (11. 5% w/ w)
1 tube 1 tube 1 tube
1 tub
Vaniqa 11.5% cream
Vaniqa 11. 5% crem
Each gram of Vaniqa 11.5% w/ w cream contains 115 mg eflornithine (as hydrochloride monohydrate).
Un gram de Vaniqa 11. 5% w/ w crem con ine eflornitin 115 mg (sub form de clorhidrat monohidrat).
Cetostearyl alcohol Stearyl alcohol.
Alcool cetostearilic Alcool stearilic
Cream.
Crem.
White to off white cream
Crem de culoare alb pân la alb- g lbui
4.1 Therapeutic indication
4. 1 Indica ii terapeutice
A thin layer of the cream should be applied to clean and dry affected areas twice daily, at least eight hours apart.
Se aplic un strat sub ire de crem pe zonele afectate, curate i uscate, de dou ori pe zi, la un interval de cel pu in opt ore.
The cream should be rubbed in thoroughly.
Crema trebuie bine introdus în piele prin frecare.
Hands should be washed after applying this medicine.
Trebuie s v sp la i pe mâini dup aplicarea acestui medicament.
For maximal efficacy, the treated area should not be cleansed within four hours of application.
Pentru eficacitate maxim, zona tratat nu trebuie cur at timp de patru ore de la aplicare.
Cosmetics (including sunscreens) can be applied over the treated areas, but no sooner than five minutes after application.
Se pot aplica produse cosmetice (inclusiv cele de protec ie solar) pe zonele tratate, dar nu mai repede de cinci minute de la aplicare.
Efficacy has only been demonstrated for affected areas of the face and under the chin.
Eficacitatea a fost demonstrat numai pentru zonele afectate ale fe ei i interiorului b rbiei.
Application should be limited to these areas.
Aplicarea trebuie s se limiteze numai la aceste zone.
The product should be applied such that no visual residual product remains on the treated areas after rub-in.
Produsul trebuie aplicat astfel încât s nu r mân în mod vizibil resturi de produs pe zonele tratate dup frecare.
Maximal applied doses used safely in clinical trials were up to 30 grams per month.
Dozele maxime aplicate utilizate în condi ii de siguran în testele clinice au fost de pân la 30 grame pe lun.
Improvement in the condition may be noticed within eight weeks of starting treatment.
Se pot observa îmbun t iri ale afec iunii în termen de opt s pt mâni de la începerea tratamentului.
Continued treatment may result in further improvement and is necessary to maintain beneficial effects.
Un tratament continuu poate duce la îmbun t iri suplimentare i este necesar între inerea efectelor benefice.
The condition may return to pre-treatment levels within eight weeks following discontinuation of treatment.
Afec iunea poate reveni la forma anterioar tratamentului în termen de opt s pt mâni de la întreruperea acestuia.
Use should be discontinued if no beneficial effects are noticed within four months of commencing therapy.
Tratamentul trebuie întrerupt dac nu se observ aspecte pozitive în termen de patru luni de la începerea acestuia.
Patients may need to continue to use a hair removal method (e. g. shaving or plucking) in conjunction with Vaniqa.
Este posibil ca pacien ii s trebuiasc s utilizeze în continuare o metod de îndep rtare a p rului (de exemplu, rasul sau depilarea) împreun cu Vaniqa.
In that case, the cream should be applied no sooner than five minutes after shaving or use of other hair removal methods, as increased stinging or burning may otherwise occur.
În acest caz, crema nu trebuie aplicat mai devreme de cinci minute de la ras sau alt metod de îndep rtare a p rului, deoarece pot fi sim ite pi c turi sau arsuri.
Elderly:
Persoanele în vârst:
(> 65 years) no dosage adjustment is necessary.
(> 65 ani) nu este necesar ajustarea dozei.
Children and Adolescents:
Copiii i adolescen ii:
(< 12 years) safety and efficacy of Vaniqa have not been established.
(< 12 ani) siguran a i eficacitatea medicamentului Vaniqa nu au fost stabilite.
2 Hepatic/ renal impairment: the safety and efficacy of Vaniqa in women with hepatic or renal impairment have not been established.
Afec iuni hepatice/ renale: siguran a i eficacitatea utiliz rii Vaniqa la femeile cu afec iuni hepatice sau renale nu au fost stabilite.
4.3 Contraindications
2 4. 3 Contraindica ii
Hypersensitivity to eflornithine or to any of the excipients (see section 6.1).
6. 1).
Excessive hair growth can result from serious underlying disorders (e. g. polycystic ovary syndrome, androgen secreting neoplasm) or certain medications (e. g. cyclosporin, glucocorticoids, minoxidil, phenobarbitone, phenytoin, combined oestrogen-androgen hormone replacement therapy).
O cre tere excesiv a p rului poate ap rea din cauza unor tulbur ri grave nedescoperite (de exemplu sindrom ovarian polichistic, neoplasm androgen cu secre ie) sau a unor medicamente (de exemplu ciclosporin, glucocorticoide, minoxidil, fenobarbiton, fenitoin, tratament combinat de înlocuire a hormonului estrogen cu androgen).
These factors should be considered in the overall medical treatment of patients who might be prescribed Vaniqa.
Ace ti factori trebuie lua i în considerare în tratamentul medical general al pacien ilor c rora este posibil s li se prescrie Vaniqa.
Vaniqa is for cutaneous use only.
Vaniqa este destinat numai uzului cutanat.
Contact with eyes or mucous membranes (e. g. nose or mouth) should be avoided.
Contactul cu ochii sau cu membranele mucoase (de exemplu, nasul sau gura) trebuie evitate.
Transient stinging or burning may occur when the cream is applied to abraded or broken skin.
La aplicarea cremei pe pielea exfoliat sau cu probleme, pot fi sim ite pi c turi sau arsuri trec toare.
If skin irritation or intolerance develops, the frequency of application should be reduced temporarily to once a day.
În cazul în care apare iritarea pielii sau intoleran a acesteia, frecven a aplic rii trebuie redus temporar la o dat pe zi.
If irritation continues, treatment should be discontinued and the physician consulted.
Dac irita ia nu dispare, trebuie întrerupt tratamentul i consultat un medic.
It is recommended that hands are washed following use.
Se recomand sp larea mâinilor dup utilizare.
As the safety of Vaniqa has not been studied in patients with severe renal impairment, caution should be used when prescribing Vaniqa for these patients.
Întrucât siguran a medicamentului Vaniqa nu a fost studiat în cazul pacien ilor cu afec iuni renale grave, prescrierea medicamentului Vaniqa se va face cu precau ie la ace ti pacien i.
This product contains cetostearyl alcohol and stearyl alcohol which may cause local skin reactions (e. g. contact dermatitis).
Acest produs con ine alcool cetostearil i stearil alcool care pot provoca reac ii locale ale pielii (de exemplu, dermatit de contact).
No interaction studies have been performed.
Nu au fost efectuate studii de interac iune.
Throughout clinical trials data from a limited number of exposed pregnancies (22) indicate that there is no clinical evidence that treatment with Vaniqa adversely affects mothers or foetuses.
În timpul testelor clinice, datele de la un num r limitat de sarcini expuse (22) arat c nu exist o dovad clinic a faptului c tratamentul cu Vaniqa are efecte negative asupra mamei sau f tului.
Among the 22 pregnancies that occurred during the trials, only 19 pregnancies occurred while the patient was using Vaniqa.
Dintre cele 22 de sarcini care au ap rut în timpul testelor clinice, doar 19 sarcini au ap rut când pacienta utiliza Vaniqa.
Of these 19 pregnancies, there were 9 healthy infants, 5 elective abortions, 4 spontaneous abortions and 1 birth defect (Down’ s Syndrome to a 35 year old).
Din aceste 19 sarcini, au rezultat 9 copii s n to i, 5 avorturi deliberate, 4 avorturi spontane i 1 defect la na tere (Sindromul Down la o femeie de 35 de ani).
To date, no other relevant epidemiological data are available.
Pân în prezent nu exist alte date epidemiologice relevante.
Animal studies have shown reproductive toxicity (see section 5.3).
5. 3).
The potential risk to humans is unknown.
Poten ialul risc la oameni este necunoscut.
Therefore, women who are pregnant or planning pregnancy should use an alternative means to manage facial hair.
În consecin, femeile care sunt gravide sau inten ioneaz s r mân gravide trebuie s utilizeze metode alternative pentru controlarea p rului facial.
Lactation: it is not known if eflornithine is excreted in human milk.
Al ptarea: nu se cunoa te dac eflornitina este secretat în laptele uman.
Women should not use Vaniqa whilst breast-feeding.
Nu se recomand utilizarea medicamentului Vaniqa de c tre femeile care al pteaz.
No studies on the effects on the ability to drive and use machines have been performed.
Nu s- au efectuat studii privind efectele asupra capacit ii de a conduce vehicule sau de a folosi utilaje.
No effect is expected.
Nu se a teapt niciun fel de efecte.
The mostly skin related adverse reactions reported were primarily mild in intensity and resolved without discontinuation of Vaniqa or initiation of medical treatment.
Reac iile adverse cutanate cel mai des întâlnite au fost, în principal, u oare ca intensitate i au fost solu ionate f r întreruperea tratamentului cu Vaniqa sau începerea unui tratament medical.
The most frequently reported undesirable effect was acne, which was generally mild.
Reac ia advers cel mai frecvent raportat a fost acneea, care în general a fost u oar.
In the vehicle controlled trials (n= 594), acne was observed in 41% of patients at baseline; 7% of patients
Dintre
Of those with no acne at baseline, similar percentages (14%) reported acne following treatment with Vaniqa or vehicle.
3 cei care nu prezentau acnee la începerea tratamentului, un procent similar (14%) au raportat acnee dup tratamentul cu Vaniqa sau excipien i.
The following listing notes the frequency of adverse skin reactions seen in clinical trials, according to MedDRA convention.
Urm toarea enumerare noteaz frecven a reac iilor adverse ale pielii în studiile clinice, conform conven iei MedDRA.
MedDRA conventions for frequency are very common (> 10%), common (> 1% to < 10%), uncommon (> 0.1% to< 1%), rare (> 0.01% to < 0.1%), or very rare (< 0.01%), including isolated reports.
Conven iile MedDRA privind frecven a sunt foarte frecvente (> 10%), frecvente (> 1% pân la < 10%), mai pu in frecvente (> 0. 1% pân la < 1%), rare (> 0. 01% pân la < 0. 1%), sau foarte rare (< 0. 01%), inclusiv raport rile izolate.
Note that over 1350 patients were treated with Vaniqa in these trials for 6 months to one year, while only slightly more than 200 patients were treated with vehicle for 6 months.
V rug m s re ine i c peste 1350 pacien i au fost trata i cu Vaniqa în aceste studii timp de 6 luni pân la un an, în timp ce pu in peste 200 pacien i au fost trata i cu excipien i timp de 6 luni.
Most events were reported at similar rates between Vaniqa and vehicle.
Majoritatea evenimentelor adverse au fost raportate la frecven e similare între Vaniqa i excipien i.
The skin effects of burning, stinging, tingling, rash and erythema were reported at higher levels in Vaniqa treated patients compared to vehicle, as indicated by the asterisk (*).
Senza iile de arsur, pi c tur, usturime, mânc rime i eritem au fost raportate la niveluri mai mari în cazul pacien ilor trata i cu Vaniqa fa de cei trata i cu excipien i, conform indica iilor prin asterisc (*).
Frequency of adverse skin reactions seen in Vaniqa clinical trials, (according to MedDRA frequency convention).
Frecven a reac iilor adverse cutanate observate în studiile clinice cu Vaniqa (conform conven iei MedDRA privind frecven a).
Very common (> 10%)
Foarte frecvente (> 10%)
Common (> 1% to < 10%)
Frecvente (> 1% pân la < 10%)
Pseudofolliculitis barbae, alopecia, stinging skin*, burning skin*, dry skin, pruritus, erythema*, tingling skin*, irritated skin, rash*, folliculitis
Pseudofolliculitis barbae, alopecie, pi c turi *, arsuri *, piele uscat, prurit, eritem *, usturime *, piele iritat, erup ii cutanate *, foliculit
Uncommon (> 0.1% to < 1%)
Mai pu in frecvente (> 0. 1% pân la < 1%)
Ingrown hair, oedema face, dermatitis, oedema mouth, papular rash, bleeding skin, herpes simplex, eczema, cheilitis, furunculosis, contact dermatitis, abnormal hair texture and abnormal hair growth, hypopigmentation, flushing skin, lip numbness, skin soreness
Fire de p r crescute în piele, edem facial, dermatit, edem bucal, erup ii cutanate papulare, sângerare a pielii, herpes simplex, eczem, cheilit, furunculoz, dermatit de contact, textur anormal a p rului, cre tere anormal a p rului, hipopigmenta ie, ro ea a pielii, amor irea buzelor, piele dureroas
Rare (> 0.01% to < 0.1%)
Rare (> 0. 01% pân la < 0. 1%)
Rosacea, seborrheic dermatitis, skin neoplasm, maculopapular rash, skin cysts, vesiculobullous rash, skin disorder, hirsutism, skin tightness
Rosacee, dermatit seboreic, neoplasm cutanat, erup ie cutanat maculo - papular, chisturi cutanate, erup ie cutanat veziculo- bulos, afec iuni cutanate, hirsutism, rigiditate a pielii
Given the minimal cutaneous penetration of eflornithine (see section 5.2), overdose is highly unlikely.
5. 2), supradozajul este foarte pu in probabil.
However, should very high dose cutaneous administration or accidental oral ingestion occur, attention should be paid to the effects seen with therapeutic doses of intravenous eflornithine (400 mg/ kg/ day or approximately 24 g/ day) used in the treatment of Trypanosoma brucei gambiense infection (African sleeping sickness): hair loss, facial swelling, seizures, hearing impairment, gastrointestinal disturbance, loss of appetite, headache, weakness, dizziness, anaemia, thrombocytopenia and leucopenia.
Totu i, în cazul administr rii unei doze cutanate foarte mari sau al înghi irii accidentale, trebuie urm rite efectele indicate în cazul dozelor terapeutice intravenoase de eflornitin (400 mg/ kg/ zi sau aproximativ 24 g/ zi) utilizate în tratamentul infec iei Trypanosoma brucei gambiense (boala somnului african): pierderea p rului, umflarea fe ei, convulsii, afectarea auzului, tulbur ri gastro- intestinale, lipsa poftei de mâncare, dureri de cap, sl biciune, ame eal, anemie, trombocitopenie i leucopenie.
Pharmacotherapeutic group: other dermatologicals, ATC code:
Grupa farmacoterapeutic: alte produse dermatologice, codul ATC:
Eflornithine irreversibly inhibits ornithine decarboxylase, an enzyme involved in the production of the hair shaft by the hair follicle.
Eflornitina inhib ireversibil ornitin decarboxilaza, o enzim implicat în producerea p rului de c tre foliculul pilos.
Vaniqa has been shown to reduce the rate of hair growth.
S- a ar tat c Vaniqa reduce rata cre terii p rului.
The safety and efficacy of Vaniqa was evaluated in two double-blind, randomised, vehicle- controlled clinical trials involving 594 women of skin types I-VI (393 on Vaniqa, 201 on vehicle) treated for up to 24 weeks.
Siguran a i eficacitatea medicamentului Vaniqa au fost evaluate în dou studii clinice dublu orb, randomizate, cu controlare a excipien ilor, la care au participat 594 femei cu piele de tip I- VI (393 tratate cu Vaniqa, 201 tratate excipien i) tratate timp de pân la 24 s pt mâni.
Physicians assessed the change from baseline on a 4-point scale, 48 hours after women had shaved the treated areas of the affected areas of the face and under the chin, considering parameters such as hair length and density, and darkening of the
Medicii au evaluat schimbarea fa de starea de la începerea tratamentului pe o scar de 4 puncte, la 48 de ore dup ce femeile au ras zonele tratate ale zonelor afectate ale fe ei i p r ii interioare a b rbiei, luând în
4 skin associated with the presence of terminal hair.
4 considerare parametri precum lungimea i densitatea p rului i închiderea la culoare a pielii, asociat cu prezen a p rului terminal.
Improvement was seen as early as 8 weeks after initiation of treatment.
O ameliorare a fost observat chiar dup 8 s pt mâni de la începerea tratamentului.
The combined results of these two trials are presented below:
Rezultatele combinate ale acestor dou studii sunt prezentate mai jos:
Outcome* Clear / almost clear Marked improvement Improved No improvement / worse
Rezultat * Curat / aproape curat Îmbun t ire semnificativ Îmbun t it Nici o îmbun t ire / înr ut ire
Vaniqa 11.5% cream 6% 29% 35% 30%
Vaniqa 11. 5% crem 6% 29% 35% 30%
Vehicle 0% 9% 33% 58%
Excipient 0% 9% 33% 58%
* At end of therapy (Week 24).
* La finalul tratamentului (S pt mâna 24).
For patients who discontinued therapy during the trial last observations were carried forward to Week 24.
Pentru pacien ii care au întrerupt tratamentul în timpul studiului, ultimele observa ii au fost trecute în s pt mâna 24.
Statistically significant (p 0.001) improvement for Vaniqa versus vehicle was seen in each of these studies for women with marked improvement and clear/ almost clear responses.
O îmbun t ire semnificativ (p 0. 001) din punct de vedere statistic pentru Vaniqa versus excipient a fost observat în fiecare dintre aceste studii la femeile cu r spuns de îmbun t ire semnificativ i cur are/ aproape cur are.
These improvements resulted in a corresponding reduction in the darkening appearance of the facial skin associated with the presence of terminal hair.
Aceste îmbun t iri au dus la o reducere corespunz toare a aspectului întunecat al pielii fe ei, asociat cu prezen a p rului terminal.
Subgroup analysis revealed a difference in treatment success where 27% of non-white women and 39% of white women showed a marked or better improvement.
O analiz de subgrup a dezv luit o diferen în reu ita tratamentului, unde 27% dintre femeile de alt culoare i 39% din femeile albe au prezentat o îmbun t ire semnificativ sau mai mare.
Subgroup analysis also showed that 29% of obese women (BMI 30) and 43% of normal weight women (BMI < 30) showed a marked or better improvement.
Analiza de subgrup a mai indicat c 29% dintre femeile obeze (BMI 30) i 43% dintre femeile cu greutate normal (BMI < 30) au prezentat o îmbun t ire semnificativ sau mai mare.
About 12% of women in the clinical trials were postmenopausal.
Aproximativ 12% dintre femeile din studiile clinice se aflau în perioada de dup menopauz.
Significant improvement (p < 0.001) versus vehicle was seen in postmenopausal women.
S- a observat o îmbun t ire semnificativ (p < 0. 001) fa de excipient la femeile aflate în perioada de dup menopauz.
Patient self-assessments demonstrated a significantly reduced psychological discomfort with the condition, as measured by responses to 6 questions on a visual analogue scale.
Autoevalu rile pacien ilor demonstreaz un disconfort psihic redus semnificativ fa de afec iune, prin m surarea r spunsurilor la 6 întreb ri pe o scar vizual analoag.
Vaniqa significantly reduced how bothered patients felt by their facial hair and by the time spent removing, treating, or concealing facial hair.
Vaniqa a redus semnificativ sentimentul de disconfort al pacien ilor fa de p rul facial i timpul folosit pentru îndep rtarea, tratarea sau ascunderea acestuia.
Patient comfort in various social and work settings was also improved.
De asemenea, a fost îmbun t it confortul pacien ilor în diverse medii sociale i de munc.
Patient self-assessments were found to correlate with physician observations of efficacy.
S- a constatat c autoevalu rile corespundeau cu observa iile medicilor cu privire la eficacitate.
These patient-observable differences were seen 8 weeks after initiating treatment.
Aceste diferen e observabile ale pacien ilor au ap rut la 8 s pt mâni de la începerea tratamentului.
The condition returned to pre-treatment levels within eight weeks after discontinuation of treatment.
Afec iunea a revenit la forma anterioar tratamentului în termen opt s pt mâni de la întreruperea tratamentului.
Steady state cutaneous penetration of eflornithine in women from Vaniqa on facial skin of shaving women was 0.8%.
La starea de echilibru, penetrarea cutanat a eflornitinei din Vaniqa la nivelul pielii fe ei la femeile care se rad a fost 0. 8%.
The steady state plasma half-life of eflornithine was approximately 8 hours.
Timpul plasmatic de înjum t ire a eflornitinei la starea de echilibru a fost de aproximativ 8 ore.
Steady state was reached within four days.
Starea de echilibru a fost atins în patru zile.
The steady state peak and trough plasma concentrations of eflornithine were approximately 10 ng/ ml and 5 ng/ ml, respectively.
Vârful st rii de echilibru i a concentra iilor plasmatice ale eflornitinei au fost aproximativ 10 ng/ ml, respectiv 5 ng/ ml.
The steady state 12-hour area under the plasma concentration versus time curve was 92.5 ng. hr/ ml.
Curba zonei cu stare de echilibru timp de 12 ore sub nivelul concentra iilor din plasm versus timp a fost 92. 5 ng. hr/ ml.
Eflornithine is not known to be metabolised and is eliminated primarily in the urine.
Eflornitina nu se cunoa te a fi metabolizat i se elimin în principal în urin.
Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose toxicity, genotoxicity and carcinogenic potential, including one photocarcinogenicity study in mice.
Pe baza studiilor conven ionale de toxicitate la doz repetat, poten ial de genotoxicitate i carcinogen, inclusiv un studiu de fotocarcinogenitate la oareci, datele non- clinice nu au eviden iat niciun risc special pentru om.
In a dermal fertility study in rats, no adverse effects on fertility were observed at up to 180 times the human dose.
Într- un studiu dermal de fertilitate la obolani, nu s- au observat efecte adverse asupra fertilit ii la doze de maxim 180 de ori fa de doza uman.
In dermal teratology studies, no teratogenic effects were observed in rats and rabbits at doses up to 180 and 36 times the human dose, respectively.
În studii de teratologie dermica, nu s- au observat efecte teratogene la obolani i iepuri la doze de pân la 180 i, respectiv, 36 de ori mai mari decât doza uman,.
Higher doses resulted in maternal and foetal toxicity without evidence of teratogenicity.
Dozele mai mari au condus la toxicitate matern i fetal, f r dovezi de teratogenicitate.
Cetostearyl alcohol; Macrogol cetostearyl ether; Dimeticone; Glyceryl stearate; Macrogol stearate; Methyl parahydroxybenzoate (E218); Liquid paraffin; Phenoxyethanol; Propyl parahydroxybenzoate (E216); Purified water Stearyl alcohol.
Alcool cetostearilic; Eter cetostearil macrogol; Dimeticon; Gliceril stearat; Macrogol stearat; Metil parahidroxibenzoat (E218); Parafin lichid; Fenoxietanol; Propil parahidroxibenzoat (E216); Ap purificat Alcool stearilic.
High density polyethylene tube with a polypropylene screw cap containing 15 g, 30 g or 60 g of cream.
Tub din polietilen de mare densitate cu un capac în urubat din polipropilen care con ine 15 g, 30 g sau 60 g de crem.
6.6 Special precautions for disposal
6. 6 Precau ii speciale de eliminare
Ronda General Mitre, 151 08022 Barcelona, Spain.
Ronda General Mitre, 151 08022 Barcelona Spania
MARKETING AUTHORISATION NUMBERS
NUMERELE AUTORIZA IEI DE PUNERE PE PIA
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
DATA PRIMEI AUTORIZ RI SAU A REÎNNOIRII AUTORIZA IEI
20 March 2001
20 martie 2001
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
DE IN TORUL AUTORIZA IEI DE FABRICA IE RESPONSABIL PENTRU ELIBERAREA SERIEI
8 A MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
8 A DE IN TORUL AUTORIZA IEI DE FABRICA IE RESPONSABIL PENTRU ELIBERAREA SERIEI
Shire Pharmaceuticals Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom
Shire Pharmaceuticals Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, Marea Britanie
Hermal Kurt Herrmann GmbH & Co OHG Scholtzstrasse 3 D-21465 Reinbek Germany
Hermal Kurt Herrmann GmbH & Co OHG Scholtzstrasse 3 D- 21465 Reinbek Germania